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Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT00835198
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : October 31, 2011
Last Update Posted : October 31, 2011
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Dapsone; Tretinoin
Drug: Tretinoin
Enrollment 163
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tretinoin Gel 0.025% Dapsone Gel 5% and Tretinoin Gel 0.025%
Hide Arm/Group Description Tretinoin gel 0.025% Dapsone gel 5% and Tretinoin gel 0.025%
Period Title: Overall Study
Started 82 81
Completed 74 74
Not Completed 8 7
Arm/Group Title Tretinoin Gel 0.025% Dapsone Gel 5% and Tretinoin Gel 0.025% Total
Hide Arm/Group Description Tretinoin gel 0.025% Dapsone gel 5% and Tretinoin gel 0.025% Total of all reporting groups
Overall Number of Baseline Participants 82 81 163
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 82 participants 81 participants 163 participants
20.2
(12.1 to 46.1)
19.7
(12.5 to 52.2)
20.0
(12.1 to 52.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 163 participants
Female
44
  53.7%
38
  46.9%
82
  50.3%
Male
38
  46.3%
43
  53.1%
81
  49.7%
1.Primary Outcome
Title Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12
Hide Description Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT), which included all patients who started the study (randomized).
Arm/Group Title Tretinoin Gel 0.025% Dapsone Gel 5% and Tretinoin Gel 0.025%
Hide Arm/Group Description:
Tretinoin gel 0.025%
Dapsone gel 5% and Tretinoin gel 0.025%
Overall Number of Participants Analyzed 82 81
Mean (Standard Deviation)
Unit of Measure: Number of Lesions
Baseline 38.96  (6.3) 40.06  (9.4)
Week 12 -24.05  (13.02) -25.82  (12.36)
2.Secondary Outcome
Title Change From Baseline in Investigator Global Assessment at Week 12
Hide Description Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT), which included all patients who started the study (randomized).
Arm/Group Title Tretinoin Gel 0.025% Dapsone Gel 5% and Tretinoin Gel 0.025%
Hide Arm/Group Description:
Tretinoin gel 0.025%
Dapsone gel 5% and Tretinoin gel 0.025%
Overall Number of Participants Analyzed 82 81
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 3.02  (0.47) 2.99  (0.43)
Week 12 -1.07  (0.85) -1.08  (0.89)
3.Secondary Outcome
Title Change From Baseline in Overall Disease Severity at Week 12
Hide Description Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT), which included all patients who started the study (randomized).
Arm/Group Title Tretinoin Gel 0.025% Dapsone Gel 5% and Tretinoin Gel 0.025%
Hide Arm/Group Description:
Tretinoin gel 0.025%
Dapsone gel 5% and Tretinoin gel 0.025%
Overall Number of Participants Analyzed 82 81
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 4.14  (0.72) 4.05  (0.77)
Week 12 -1.79  (1.21) -1.76  (1.29)
4.Secondary Outcome
Title Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12
Hide Description Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or "pimples") lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT), which included all patients who started the study (randomized).
Arm/Group Title Tretinoin Gel 0.025% Dapsone Gel 5% and Tretinoin Gel 0.025%
Hide Arm/Group Description:
Tretinoin gel 0.025%
Dapsone gel 5% and Tretinoin gel 0.025%
Overall Number of Participants Analyzed 82 81
Mean (Standard Deviation)
Unit of Measure: Number of lesions
Baseline 40.94  (11.13) 40.69  (10.17)
Week 12 -19.91  (13.2) -15.81  (21.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tretinoin Gel 0.025% Dapsone Gel 5% and Tretinoin Gel 0.025%
Hide Arm/Group Description Tretinoin gel 0.025% Dapsone gel 5% and Tretinoin gel 0.025%
All-Cause Mortality
Tretinoin Gel 0.025% Dapsone Gel 5% and Tretinoin Gel 0.025%
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tretinoin Gel 0.025% Dapsone Gel 5% and Tretinoin Gel 0.025%
Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)   0/81 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tretinoin Gel 0.025% Dapsone Gel 5% and Tretinoin Gel 0.025%
Affected / at Risk (%) Affected / at Risk (%)
Total   12/82 (14.63%)   10/81 (12.35%) 
Infections and infestations     
Cold *  8/82 (9.76%)  7/81 (8.64%) 
Nervous system disorders     
Headache *  4/82 (4.88%)  3/81 (3.70%) 
*
Indicates events were collected by non-systematic assessment
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.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Results Point of Contact
Name/Title: Vice President Medical Affairs
Organization: Allergan, Inc.
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00835198     History of Changes
Other Study ID Numbers: MA-ACZ0801
First Submitted: January 30, 2009
First Posted: February 3, 2009
Results First Submitted: September 22, 2011
Results First Posted: October 31, 2011
Last Update Posted: October 31, 2011