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Efficacy and the Tolerability of the Sequential Application of Two Marketed Products in Patients With Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT01461655
Recruitment Status : Completed
First Posted : October 28, 2011
Results First Posted : December 4, 2013
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: marketed topical retinoid
Drug: marketed topical NSAID
Drug: vehicle gel
Enrollment 40
Recruitment Details Start date: 21-NOV-2011 (FSFV - first subject first visit) Completion date: 26-APR-2012 (LSLV - last subject last visit)
Pre-assignment Details  
Arm/Group Title Topical Retinoid - Placebo, Topical Retinoid - NSAID
Hide Arm/Group Description

Using a left-right split face set up, the study evaluated the effect of sequential application of topical retinoid 0.1% gel and NSAID 5% gel in comparison with the sequential application of topical retinoid 0.1% gel and vehicle gel for the treatment of acne vulgaris.

The randomised subjects received the following products:

  • NSAID 5% gel , in the morning on the appropriate hemiface.
  • Topical retinoid 0.1% gel, in the evening on the entire face.
  • Vehicle gel, in the morning on the appropriate hemiface.
Period Title: Overall Study
Started 40
Completed 40
Not Completed 0
Arm/Group Title Topical Retinoid - Placebo, Topical Retinoid - NSAID
Hide Arm/Group Description

marketed topical retinoid : once daily application, 4 weeks

vehicle gel : once daily application, 4 weeks

Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
23.7  (4.2)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
23
  57.5%
Male
17
  42.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 40 participants
40
1.Primary Outcome
Title Percentage Change in Inflammatory Lesions From Baseline to End of Treatment
Hide Description Percentage change in inflammatory lesions count from baseline to the end of treatment
Time Frame Baseline to End of treatment (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical Retinoid - Placebo Topical Retinoid-NSAID
Hide Arm/Group Description:

marketed topical retinoid : once daily application, 4 weeks

vehicle gel : once daily application, 4 weeks

marketed topical NSAID : once daily application, 4 weeks

marketed topical retinoid : once daily application, 4 weeks

Overall Number of Participants Analyzed 40 40
Median (Standard Deviation)
Unit of Measure: percentage of change
-20.3  (45.3) -29.4  (37.0)
2.Secondary Outcome
Title Non-inflammatory Lesions Count
Hide Description Percentage change in non-inflammatory lesions count from baseline to the end of treatment
Time Frame Baseline to End of treatment (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical Retinoid - Placebo Topical Retinoid-NSAID
Hide Arm/Group Description:

marketed topical retinoid : once daily application, 4 weeks

vehicle gel : once daily application, 4 weeks

marketed topical NSAID : once daily application, 4 weeks

marketed topical retinoid : once daily application, 4 weeks

Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: percentage of change
-41.4  (31.2) -43.1  (37.6)
3.Secondary Outcome
Title Total Lesions Count
Hide Description Percentage change in total lesions count from baseline to the end of treatment
Time Frame Baseline to End of treatment (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical Retinoid - Placebo Topical Retinoid-NSAID
Hide Arm/Group Description:

marketed topical retinoid : once daily application, 4 weeks

vehicle gel : once daily application, 4 weeks

marketed topical NSAID : once daily application, 4 weeks

marketed topical retinoid : once daily application, 4 weeks

Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: percentage of change
-35.4  (24.0) -39.9  (27.0)
4.Secondary Outcome
Title Percentage Change in Total Lesions Count
Hide Description Percentage change in total leasions count from baseline to day 8
Time Frame Baseline to Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical Retinoid - Placebo Topical Retinoid-NSAID
Hide Arm/Group Description:

marketed topical retinoid : once daily application, 4 weeks

vehicle gel : once daily application, 4 weeks

marketed topical NSAID : once daily application, 4 weeks

marketed topical retinoid : once daily application, 4 weeks

Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: percentage of change
-20.4  (24.1) -21.1  (28.6)
5.Secondary Outcome
Title Percentage Change in Total Lesions Count
Hide Description Percentage change in total lesions count from baseline to day 15
Time Frame Baseline to Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical Retinoid - Placebo Topical Retinoid-NSAID
Hide Arm/Group Description:

marketed topical retinoid : once daily application, 4 weeks

vehicle gel : once daily application, 4 weeks

marketed topical NSAID : once daily application, 4 weeks

marketed topical retinoid : once daily application, 4 weeks

Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: percentage of change
-24.9  (24.3) -22.2  (29.0)
6.Secondary Outcome
Title Percentage Change in Total Lesions Count
Hide Description Percentage change in total lesions count from baseline to day 22
Time Frame Baseline to Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical Retinoid - Placebo Topical Retinoid-NSAID
Hide Arm/Group Description:

marketed topical retinoid : once daily application, 4 weeks

vehicle gel : once daily application, 4 weeks

marketed topical NSAID : once daily application, 4 weeks

marketed topical retinoid : once daily application, 4 weeks

Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: percentage of change
-35.7  (21.8) -32.5  (30.0)
7.Secondary Outcome
Title Investigator Global Assessment (IGA) of Disease Severity
Hide Description

The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe).

The outcome was the proportion of "success" (improvement of two grades of the IGA) from baseline to the end of treatment. “Success” is defined as improvement of two grades from the baseline assessment.

Time Frame Baseline to End of treatment (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical Retinoid - Placebo Topical Retinoid-NSAID
Hide Arm/Group Description:

marketed topical retinoid : once daily application, 4 weeks

vehicle gel : once daily application, 4 weeks

marketed topical NSAID : once daily application, 4 weeks

marketed topical retinoid : once daily application, 4 weeks

Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: participants
0 1
Time Frame Adverse events were collected from study start untill 43 (±2)days after the last on-treatment visit if an AE (serious or non-serious) classified as possible or probably related to the study treatment was ongoing at the last on-treatment visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Topical Retinoid - Placebo, Topical Retinoid - NSAID
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Topical Retinoid - Placebo, Topical Retinoid - NSAID
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Topical Retinoid - Placebo, Topical Retinoid - NSAID
Affected / at Risk (%)
Total   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Topical Retinoid - Placebo, Topical Retinoid - NSAID
Affected / at Risk (%)
Total   40/40 (100.00%) 
Eye disorders   
Eyelid oedema * 1  2/40 (5.00%) 
Infections and infestations   
Nasopharyngitis * 1  5/40 (12.50%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  3/40 (7.50%) 
Nervous system disorders   
Headache * 1  9/40 (22.50%) 
Migraine * 1  2/40 (5.00%) 
Reproductive system and breast disorders   
Dysmenorrhoea * 1  7/40 (17.50%) 
Skin and subcutaneous tissue disorders   
Eczema * 1  2/40 (5.00%) 
Rash erythematous * 1  2/40 (5.00%) 
Skin irritation * 1  37/40 (92.50%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.1
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.
Prior to submitting or presenting a manuscript, the investigator shall provide to LEO Pharma a copy of all such manuscripts, and LEO Pharma shall have rights to review and comment. Upon the request of LEO Pharma the investigator shall remove any confidential information prior to submitting or presenting the manuscripts. The investigator shall, upon the request of LEO Pharma, delay publication or presentation to allow LEO Pharma to protect its inventions and other intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosure Manager
Organization: LEO Pharma A/S
Phone: +45 4494 5888
EMail: disclosure@leo-pharma.com
Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01461655     History of Changes
Other Study ID Numbers: LP0045-01
2011-000244-24 ( EudraCT Number )
First Submitted: October 25, 2011
First Posted: October 28, 2011
Results First Submitted: April 17, 2013
Results First Posted: December 4, 2013
Last Update Posted: February 15, 2017