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Trial record 4 of 146 for:    acne AND erythema

A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products

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ClinicalTrials.gov Identifier: NCT01313728
Recruitment Status : Completed
First Posted : March 14, 2011
Results First Posted : January 19, 2012
Last Update Posted : February 15, 2012
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Dapsone plus Tretinoin Gel
Drug: Tretinoin Gel
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Overall Study
Hide Arm/Group Description This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
Period Title: Informed Consent to Baseline
Started 26
Completed 25 [1]
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
[1]
One subject withdrew after signing informed consent, but prior to Baseline measurements being taken.
Period Title: Baseline to Completion
Started 25
Completed 25
Not Completed 0
Arm/Group Title Overall Study
Hide Arm/Group Description This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
 100.0%
>=65 years
0
   0.0%
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants
25
[1]
Measure Description: Gender was not a relevant measure for the trial, and was not recorded. Number reported reflects Participants in the overall study who were either Male or Female.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
Fitzpatrick Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants
Type I 1
Type II 10
Type III 14
[1]
Measure Description: Skin type is categorized according to the Fitzpatrick skin type scale, which ranges from very fair (skin type I) to very dark (skin type VI). Only Skin Types I-III were included in this study.
1.Primary Outcome
Title Expert Grader Assessment - Erythema
Hide Description Ordinal erythema scores (on a scale of 0=none to 8=severe scaling and fissuring) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).
Time Frame Baseline to 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title Dapsone Gel + Tretinoin Gel Tretinoin Gel Alone
Hide Arm/Group Description:
Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
Tretinoin gel applied once daily to the assigned side of the face
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: Scores on a Scale
Day 0 = Baseline 0.0 0.0
Day 1 0.4 2.0
Day 2 0.4 2.0
Day 3 1.6 6.4
Day 4 6.8 7.6
Day 7 9.7 17.1
Day 8 10.8 20.9
Day 9 10.6 20.1
Day 10 11.6 20.4
Day 11 11.6 23.0
Day 14 16.6 19.5
2.Primary Outcome
Title Expert Grader Assessment - Dryness
Hide Description Ordinal dryness scores (on a scale of 0=none to 8=deep) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).
Time Frame Baseline to 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title Dapsone Gel + Tretinoin Gel Tretinoin Gel Alone
Hide Arm/Group Description:
Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
Tretinoin gel applied once daily to the assigned side of the face
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: Scores on a Scale
Day 0 = Baseline 0.0 0.0
Day 1 0.6 1.8
Day 2 1.7 2.5
Day 3 3.5 8.1
Day 4 12.6 14.2
Day 7 14.8 19.9
Day 8 18.5 25.6
Day 9 13.6 23.0
Day 10 20.4 37.6
Day 11 17.3 37.6
Day 14 23.5 28.3
3.Secondary Outcome
Title Subject Assessment – Burning/Stinging
Hide Description Ordinal burning/stinging scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).
Time Frame Baseline to 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title Dapsone Gel + Tretinoin Gel Tretinoin Gel Alone
Hide Arm/Group Description:
Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
Tretinoin gel applied once daily to the assigned side of the face
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: Scores on a Scale
Day 0 = Baseline 1.0 0.0
Day 1 2.6 1.6
Day 2 1.8 2.6
Day 3 6.6 5.5
Day 4 8.7 12.2
Day 7 7.5 9.5
Day 8 14.5 17.2
Day 9 9.6 20.2
Day 10 11.6 25.9
Day 11 10.6 25.9
Day 14 14.6 23.2
4.Secondary Outcome
Title Subject Assessment – Itching
Hide Description Ordinal itching scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).
Time Frame Baseline to 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title Dapsone Gel + Tretinoin Gel Tretinoin Gel Alone
Hide Arm/Group Description:
Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
Tretinoin gel applied once daily to the assigned side of the face
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: Scores on a Scale
Day 0 = Baseline 0.0 0.0
Day 1 1.6 2.8
Day 2 0.5 1.9
Day 3 0.6 1.8
Day 4 2.6 2.8
Day 7 3.6 7.6
Day 8 5.6 12.4
Day 9 5.6 12.4
Day 10 7.6 17.1
Day 11 8.6 13.4
Day 14 7.6 9.4
5.Secondary Outcome
Title Subject Assessment – Tightness
Hide Description Ordinal tightness scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).
Time Frame Baseline to 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title Dapsone Gel + Tretinoin Gel Tretinoin Gel Alone
Hide Arm/Group Description:
Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
Tretinoin gel applied once daily to the assigned side of the face
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: Scores on a Scale
Day 0 = Baseline 0.0 0.0
Day 1 1.5 1.8
Day 2 1.5 2.9
Day 3 2.6 4.7
Day 4 5.7 8.5
Day 7 8.6 12.5
Day 8 12.5 19.0
Day 9 11.6 17.2
Day 10 12.5 20.0
Day 11 9.6 15.3
Day 14 10.5 14.4
6.Secondary Outcome
Title Facial Tolerance
Hide Description All interval measurements were combined for comparative assessment between treatment regimens. Facial tolerance is the sum of scores from Erythema, Dryness, Burning/Stinging, Itching, and Tightness assessments, reported in Outcome Measures 1-5. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 6250 (highest possible combined score of 25, times 10 days, times 25 subjects).
Time Frame Baseline to 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapsone Gel + Tretinoin Gel Tretinoin Gel Alone
Hide Arm/Group Description:
Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
Tretinoin gel applied once daily to the assigned side of the face
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: Scores on a Scale
Day 0 = Baseline 1.0 0.0
Day 1 6.7 10.0
Day 2 5.9 11.9
Day 3 14.9 26.5
Day 4 36.4 45.3
Day 7 44.2 66.6
Day 8 61.9 95.1
Day 9 51.0 93.9
Day 10 63.7 124.6
Day 11 57.7 115.2
Day 14 72.8 94.8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall Study
Hide Arm/Group Description This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
All-Cause Mortality
Overall Study
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Overall Study
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Overall Study
Affected / at Risk (%)
Total   2/25 (8.00%) 
Skin and subcutaneous tissue disorders   
Irritation  2/25 (8.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Lineberry, Associate Director, Clinical Operations
Organization: Valeant Pharmaceuticals International Inc
Phone: 949-973-1153
EMail: David.Lineberry@valeant.com
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT01313728     History of Changes
Other Study ID Numbers: CA-P-7966
First Submitted: March 10, 2011
First Posted: March 14, 2011
Results First Submitted: October 14, 2011
Results First Posted: January 19, 2012
Last Update Posted: February 15, 2012