Trial Outcomes & Findings for Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris (NCT NCT00835198)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

163 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2011-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Tretinoin Gel 0.025% Tretinoin gel 0.025%	Dapsone Gel 5% and Tretinoin Gel 0.025% Dapsone gel 5% and Tretinoin gel 0.025%
Overall Study STARTED	82	81
Overall Study COMPLETED	74	74
Overall Study NOT COMPLETED	8	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tretinoin Gel 0.025% n=82 Participants Tretinoin gel 0.025%	Dapsone Gel 5% and Tretinoin Gel 0.025% n=81 Participants Dapsone gel 5% and Tretinoin gel 0.025%	Total n=163 Participants Total of all reporting groups
Age Continuous	20.2 years n=5 Participants	19.7 years n=7 Participants	20.0 years n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	38 Participants n=7 Participants	82 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	43 Participants n=7 Participants	81 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Intent-to-treat (ITT), which included all patients who started the study (randomized).

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).

Outcome measures

Outcome measures
Measure	Tretinoin Gel 0.025% n=82 Participants Tretinoin gel 0.025%	Dapsone Gel 5% and Tretinoin Gel 0.025% n=81 Participants Dapsone gel 5% and Tretinoin gel 0.025%
Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 Baseline	38.96 Number of Lesions Standard Deviation 6.3	40.06 Number of Lesions Standard Deviation 9.4
Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 Week 12	-24.05 Number of Lesions Standard Deviation 13.02	-25.82 Number of Lesions Standard Deviation 12.36

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intent-to-treat (ITT), which included all patients who started the study (randomized).

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).

Outcome measures

Outcome measures
Measure	Tretinoin Gel 0.025% n=82 Participants Tretinoin gel 0.025%	Dapsone Gel 5% and Tretinoin Gel 0.025% n=81 Participants Dapsone gel 5% and Tretinoin gel 0.025%
Change From Baseline in Investigator Global Assessment at Week 12 Baseline	3.02 Scores on a scale Standard Deviation 0.47	2.99 Scores on a scale Standard Deviation 0.43
Change From Baseline in Investigator Global Assessment at Week 12 Week 12	-1.07 Scores on a scale Standard Deviation 0.85	-1.08 Scores on a scale Standard Deviation 0.89

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intent-to-treat (ITT), which included all patients who started the study (randomized).

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).

Outcome measures

Outcome measures
Measure	Tretinoin Gel 0.025% n=82 Participants Tretinoin gel 0.025%	Dapsone Gel 5% and Tretinoin Gel 0.025% n=81 Participants Dapsone gel 5% and Tretinoin gel 0.025%
Change From Baseline in Overall Disease Severity at Week 12 Baseline	4.14 Scores on a scale Standard Deviation 0.72	4.05 Scores on a scale Standard Deviation 0.77
Change From Baseline in Overall Disease Severity at Week 12 Week 12	-1.79 Scores on a scale Standard Deviation 1.21	-1.76 Scores on a scale Standard Deviation 1.29

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intent-to-treat (ITT), which included all patients who started the study (randomized).

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).

Outcome measures

Outcome measures
Measure	Tretinoin Gel 0.025% n=82 Participants Tretinoin gel 0.025%	Dapsone Gel 5% and Tretinoin Gel 0.025% n=81 Participants Dapsone gel 5% and Tretinoin gel 0.025%
Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 Week 12	-19.91 Number of lesions Standard Deviation 13.2	-15.81 Number of lesions Standard Deviation 21.3
Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 Baseline	40.94 Number of lesions Standard Deviation 11.13	40.69 Number of lesions Standard Deviation 10.17

Adverse Events

Tretinoin Gel 0.025%

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Dapsone Gel 5% and Tretinoin Gel 0.025%

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tretinoin Gel 0.025% n=82 participants at risk Tretinoin gel 0.025%	Dapsone Gel 5% and Tretinoin Gel 0.025% n=81 participants at risk Dapsone gel 5% and Tretinoin gel 0.025%
Infections and infestations Cold	9.8% 8/82	8.6% 7/81
Nervous system disorders Headache	4.9% 4/82	3.7% 3/81

Additional Information

Vice President Medical Affairs

Allergan, Inc.

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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
Publication restrictions are in place

Restriction type: OTHER