Trial Outcomes & Findings for Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris (NCT NCT02944461)

NCT ID: NCT02944461

Last Updated: 2019-04-03

Results Overview

Investigator will evaluate global acne severity using the IGA scale as follows: 1= Clear Skin, 2 = Almost Clear, 3 = Mild Severity, 4 = Severe, 5 = Very Severe

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2019-04-03

Participant Flow

Participant milestones

Measure	Dapsone Gel 7.5% Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks. Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne
Overall Study STARTED	20
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris

Baseline characteristics by cohort

Measure	Dapsone Gel 7.5% n=20 Participants Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks. Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne
Age, Continuous	21 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Investigator will evaluate global acne severity using the IGA scale as follows: 1= Clear Skin, 2 = Almost Clear, 3 = Mild Severity, 4 = Severe, 5 = Very Severe

Outcome measures

Measure	Dapsone Gel 7.5% n=15 Participants Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks. Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne
Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale week 4	0 Participants
Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale week 10	3 Participants
Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale week 16	7 Participants

SECONDARY outcome

Timeframe: 16 Weeks

Outcome measures

Measure	Dapsone Gel 7.5% n=15 Participants Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks. Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne
The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline	-74 percent change in lesion count Standard Deviation 21

SECONDARY outcome

Timeframe: 16 Weeks

Outcome measures

Measure	Dapsone Gel 7.5% n=15 Participants Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks. Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne
The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline	-72 percent change in lesion count Standard Deviation 28

SECONDARY outcome

Timeframe: 16 Weeks

Outcome measures

Measure	Dapsone Gel 7.5% n=15 Participants Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks. Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne
The Percent Change in Total Lesion Count at Week 16 Compared to Baseline	-73 percent change in lesion count Standard Deviation 23

Adverse Events

Dapsone Gel 7.5%

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Dapsone Gel 7.5% n=20 participants at risk Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks. Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne
Skin and subcutaneous tissue disorders infected abrasions of legs	5.0% 1/20 • Number of events 1 • 16 weeks
Surgical and medical procedures gum graft surgery	5.0% 1/20 • Number of events 1 • 16 weeks
Eye disorders stye, right eye	5.0% 1/20 • Number of events 1 • 16 weeks
Skin and subcutaneous tissue disorders sunburn arms/chest/back	5.0% 1/20 • Number of events 1 • 16 weeks

Additional Information

M. McAllister

Skin Sciences, PLLC

Phone: 5024519000

Email: mmdermresearch@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place