Trial Outcomes & Findings for A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris (NCT NCT02032407)

Results Overview

The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

68 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2015-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	Dapsone Gel Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Overall Study STARTED	68
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Dapsone Gel Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Overall Study Lost to Follow-up	2
Overall Study Pregnancy	1
Overall Study Other Miscellaneous Reasons	2

Baseline Characteristics

A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dapsone Gel n=67 Participants Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Age, Customized 18 to <30 years	32 participants n=5 Participants
Age, Customized ≥30 to <50 years	32 participants n=5 Participants
Age, Customized ≥50 years	3 participants n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Modified Intent-to treat (mITT) population included all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment.

The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Dapsone Gel n=67 Participants Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician Baseline	2.8 score on a scale Standard Deviation 0.72
Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician Change from Baseline at Week 12	-1.2 score on a scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: Baseline, Weeks 2 and 6

Population: Modified Intent-to treat (mITT) population included all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment.

The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Dapsone Gel n=67 Participants Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Change From Baseline in the GAAS Baseline	2.8 score on a scale Standard Deviation 0.72
Change From Baseline in the GAAS Change from Baseline at Week 2	-0.3 score on a scale Standard Deviation 0.63
Change From Baseline in the GAAS Change from Baseline at Week 6	-0.6 score on a scale Standard Deviation 0.74

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 6 and 12

Population: Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.

The investigator evaluated Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement).

Outcome measures

Outcome measures
Measure	Dapsone Gel n=67 Participants Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Percent Change From Baseline in Total Lesion Counts Change from Baseline at Week 2	-16.0 percent change Standard Deviation 23.45
Percent Change From Baseline in Total Lesion Counts Change from Baseline at Week 6 (n=61)	-30.0 percent change Standard Deviation 26.15
Percent Change From Baseline in Total Lesion Counts Change from Baseline at Week 12 (n=63)	-52.0 percent change Standard Deviation 26.96

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 6 and 12

Population: Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.

The investigator evaluated Inflammatory lesions (papule, pustule and nodule/cyst). A negative percent change from baseline indicates a reduction in lesion counts (improvement).

Outcome measures

Outcome measures
Measure	Dapsone Gel n=67 Participants Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Percent Change From Baseline in Inflammatory Lesion Counts Change from Baseline at Week 2	-25.0 percent change Standard Deviation 32.01
Percent Change From Baseline in Inflammatory Lesion Counts Change from Baseline at Week 6 (n=61)	-48.0 percent change Standard Deviation 26.72
Percent Change From Baseline in Inflammatory Lesion Counts Change from Baseline at Week 12 (n=63)	-65.0 percent change Standard Deviation 23.31

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 6 and 12

Population: Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.

The investigator evaluated Non-inflammatory (blackhead and whitehead) lesions. A negative percent change from baseline indicates a reduction in lesion counts (improvement).

Outcome measures

Outcome measures
Measure	Dapsone Gel n=67 Participants Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Percent Change From Baseline in Non-Inflammatory Lesion Counts Change from Baseline at Week 2	-9.8 percent change Standard Deviation 32.03
Percent Change From Baseline in Non-Inflammatory Lesion Counts Change from Baseline at Week 6 (n=61)	-16.0 percent change Standard Deviation 36.19
Percent Change From Baseline in Non-Inflammatory Lesion Counts Change from Baseline at Week 12 (n=63)	-41.0 percent change Standard Deviation 34.15

SECONDARY outcome

Timeframe: Weeks 2, 6 and 12

Population: Participants from the mITT, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.

The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. The percentage of participants with a score of 0=none or 1=minimal is reported.

Outcome measures

Outcome measures
Measure	Dapsone Gel n=67 Participants Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS Week 2	6.0 percentage of participants
Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS Week 6 (n=61)	13.1 percentage of participants
Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS Week 12 (n=63)	42.9 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 6 and 12

Population: Participants from the mITT population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data at the given time-point.

The participant assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. Higher scores indicate the presence of more severe signs of acne.

Outcome measures

Outcome measures
Measure	Dapsone Gel n=67 Participants Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Acne Symptom and Impact Scale (ASIS) Sign Domain Score Week 2	1.7 score on a scale Standard Deviation 0.72
Acne Symptom and Impact Scale (ASIS) Sign Domain Score Week 6 (n=60)	1.3 score on a scale Standard Deviation 0.68
Acne Symptom and Impact Scale (ASIS) Sign Domain Score Week 12 (n=63)	1.1 score on a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: Weeks 2, 6 and 12

Population: Participants from the mITT population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available for analysis at the given time-point.

The participant assessed the impact of acne vulgaris using the ASIS. The impact domain is a composite of 8 items assessing the psychosocial impacts (6 items emotional and 2 items social) of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The impact domain score is calculated as the average of the 8 items for a total possible score of 0 to 4. Higher scores on the ASIS Impact Domain indicate greater negative impact of acne on health-related quality of life and appearance.

Outcome measures

Outcome measures
Measure	Dapsone Gel n=67 Participants Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
ASIS Impact Domain Score Week 2	1.6 score on a scale Standard Deviation 0.91
ASIS Impact Domain Score Week 6 (n=60)	1.3 score on a scale Standard Deviation 0.91
ASIS Impact Domain Score Week 12 (n=63)	1.1 score on a scale Standard Deviation 0.91

Adverse Events

Dapsone Gel

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dapsone Gel n=68 participants at risk Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Reproductive system and breast disorders Spontaneous abortion	1.5% 1/68

Other adverse events

Adverse event data not reported

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