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A Short-contact Plaque Test Study With Daivobet® Gel in Psoriasis Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01607853
Recruitment Status : Completed
First Posted : May 30, 2012
Results First Posted : December 24, 2013
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Investigator)
Condition Psoriasis Vulgaris
Interventions Drug: Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes)
Drug: Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes)
Drug: Daivobet® gel applied for 24 hours (+/- 2 hours)
Drug: Daivobet® gel vehicle applied for 24 hours (+/- 2 hours)
Enrollment 24
Recruitment Details Start date: 28-Jun-2012 Completion date: 15-Oct-2012
Pre-assignment Details Prior to randomisation, the subjects entered a washout phase (if required) where antipsoriatic treatment and other relevant treatments had to be discontinued as defined by the exclusion criteria. Depending on prior use of disallowed treatments, the washout phase could last for up to 21 days.
Arm/Group Title Daivobet® Gel
Hide Arm/Group Description

Each of the 24 subjects participating in this exploratory trial received:

  • Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
  • Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
  • Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
  • Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title Daivobet® Gel
Hide Arm/Group Description

Each of the 24 subjects participating in this exploratory trial received:

  • Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
  • Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
  • Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
  • Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
  83.3%
>=65 years
4
  16.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
46.7  (14.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
7
  29.2%
Male
17
  70.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 24 participants
24
1.Primary Outcome
Title Change in Total Clinical Score From Baseline to Day 22
Hide Description Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clincal Score
Time Frame baseline to day 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.6  (1.6) -3.7  (2.0) -4.9  (1.5) -1.3  (0.9)
2.Secondary Outcome
Title Change in Total Clinical Score at Day 4 Compared to Baseline
Hide Description Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.
Time Frame Baseline to day 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.5  (0.8) -0.5  (0.6) -0.4  (0.7) -0.1  (0.5)
3.Secondary Outcome
Title Change in Total Clinical Score at Day 8 Compared to Baseline
Hide Description Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.
Time Frame Baseline to day 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.5  (1.2) -1.4  (1.4) -1.6  (1.3) -0.2  (0.9)
4.Secondary Outcome
Title Change in Total Clinical Score at Day 11 Compared to Baseline
Hide Description Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.
Time Frame Baseline to day 11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.3  (1.4) -2.3  (1.4) -3.0  (1.4) -0.7  (1.0)
5.Secondary Outcome
Title Change in Total Clinical Score at Day 15 Compared to Baseline
Hide Description Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinial Score.
Time Frame Baseline to day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.0  (1.3) -2.8  (1.6) -3.9  (1.5) -0.9  (1.1)
6.Secondary Outcome
Title Change in Total Clinical Score at Day 18 Compared to Baseline
Hide Description Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.
Time Frame Baseline to day 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.4  (1.5) -3.4  (1.6) -4.3  (1.5) -1.1  (1.0)
7.Secondary Outcome
Title Change From Baseline in Erythema at Day 4.
Hide Description Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.17  (0.32) -0.23  (0.36) -0.23  (0.36) -0.06  (0.22)
8.Secondary Outcome
Title Change From Baseline in Erythema at Day 8.
Hide Description Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.54  (0.51) -0.56  (0.50) -0.67  (0.55) -0.15  (0.35)
9.Secondary Outcome
Title Change From Baseline in Erythema at Day 11
Hide Description Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.79  (0.57) -0.85  (0.52) -1.06  (0.58) -0.27  (0.36)
10.Secondary Outcome
Title Change From Baseline in Erythema at Day 15
Hide Description Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.00  (0.49) -1.04  (0.62) -1.29  (0.57) -0.31  (0.48)
11.Secondary Outcome
Title Change From Baseline in Erythema at Day 18
Hide Description Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.04  (0.53) -1.19  (0.53) -1.42  (0.50) -0.46  (0.41)
12.Secondary Outcome
Title Change From Baseline in Erythema at Day 22
Hide Description Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.17  (0.60) -1.31  (0.66) -1.56  (0.61) -0.42  (0.41)
13.Secondary Outcome
Title Change From Baseline in Infiltration at Day 4
Hide Description Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.10  (0.29) -0.08  (0.28) -0.10  (0.25) 0.02  (0.10)
14.Secondary Outcome
Title Change From Baseline in Infiltration at Day 8
Hide Description Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.33  (0.38) -0.33  (0.50) -0.38  (0.47) 0.00  (0.26)
15.Secondary Outcome
Title Change From Baseline in Infiltration at Day 11
Hide Description Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 2 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.63  (0.52) -0.60  (0.59) -0.81  (0.53) -0.08  (0.32)
16.Secondary Outcome
Title Change From Baseline in Infiltration at Day 15
Hide Description Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.81  (0.55) -0.73  (0.63) -1.19  (0.62) -0.15  (0.28)
17.Secondary Outcome
Title Change From Baseline in Infiltration at Day 18
Hide Description Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.00  (0.59) -0.98  (0.70) -1.42  (0.65) -0.17  (0.32)
18.Secondary Outcome
Title Change From Baseline in Infiltration at Day 22
Hide Description Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.08  (0.60) -1.06  (0.74) -1.60  (0.61) -0.31  (0.32)
19.Secondary Outcome
Title Change From Baseline in Scaling at Day 4
Hide Description Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.19  (0.32) -0.19  (0.29) -0.10  (0.33) -0.08  (0.35)
20.Secondary Outcome
Title Change From Baseline in Scaling at Day 8
Hide Description Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.60  (0.55) -0.46  (0.57) -0.56  (0.52) -0.06  (0.45)
21.Secondary Outcome
Title Change From Baseline in Scaling at Day 11
Hide Description Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.90  (0.57) -0.88  (0.45) -1.08  (0.58) -0.35  (0.50)
22.Secondary Outcome
Title Change From Baseline in Scaling at Day 15
Hide Description Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.15  (0.54) -1.04  (0.55) -1.40  (0.53) -0.42  (0.55)
23.Secondary Outcome
Title Change From Baseline in Scaling at Day 18
Hide Description Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.35  (0.56) -1.27  (0.61) -1.50  (0.63) -0.48  (0.45)
24.Secondary Outcome
Title Change From Baseline in Scaling at Day 22
Hide Description Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time Frame Baseline to day 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.31  (0.60) -1.31  (0.70) -1.71  (0.53) -0.54  (0.41)
25.Secondary Outcome
Title Change in Lesion Thickness Measured by Ultrasound From Baseline to Day 22.
Hide Description [Not Specified]
Time Frame Baseline to day 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: millimeters
-0.61  (0.47) -0.80  (0.57) -0.90  (0.51) -0.11  (0.26)
26.Secondary Outcome
Title Change in Skin Thickness - Echo-poor Band - Measured by Ultrasound From Baseline to Day 22
Hide Description [Not Specified]
Time Frame Baseline to day 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daivobet® Gel Applied Then Removed After 10 Minutes Daivobet® Gel Applied Then Removed After 20 Minutes Daivobet® Gel Applied for 24 Hours Daivobet® Gel Vehicle Applied for 24 Hours
Hide Arm/Group Description:

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: millimeters
-0.57  (0.35) -0.54  (0.50) -0.62  (0.33) -0.06  (0.30)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Daivobet® Gel
Hide Arm/Group Description

Each of the 24 subjects participating in this exploratory trial received:

  • Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
  • Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
  • Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
  • Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks

The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.

All-Cause Mortality
Daivobet® Gel
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Daivobet® Gel
Affected / at Risk (%)
Total   0/24 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Daivobet® Gel
Affected / at Risk (%)
Total   4/24 (16.67%) 
Infections and infestations   
Nasopharyngititis * 1  2/24 (8.33%) 
Nervous system disorders   
Headache * 1  2/24 (8.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1

In this small exploratory trial the subjects received all 4 investigational products on small dermal test sites.

Regarding Adverse Events, only local dermal reactions could be potentially attributed to a specific investigational product.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor is entitled to review and comment on publications prior to submission or presentation. Upon request of the sponsor, the investigator shall delay publication or presentation to allow for protection of the sponsors inventions and other intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosure Manager
Organization: Leo Pharma A/S
Phone: 00 45 44 94 58 88
EMail: ctr.disclosure@leo-pharma.com
Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01607853    
Other Study ID Numbers: LP0076-57
2012-001507-21 ( EudraCT Number )
First Submitted: May 23, 2012
First Posted: May 30, 2012
Results First Submitted: November 4, 2013
Results First Posted: December 24, 2013
Last Update Posted: April 14, 2015