Trial Outcomes & Findings for Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris (NCT NCT01047189)

NCT ID: NCT01047189

Last Updated: 2018-09-10

Results Overview

Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 26 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2018-09-10

Participant Flow

Participants were recruited from IRB approved advertising and the Wake Forest University Health Sciences Dermatology Clinic

Participant milestones

Measure	Ziana Gel Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks	Clindamycin Plus Tretinoin Applied Separately Generic clindamycin 1% gel plus tretinoin 0.025% cream
Overall Study STARTED	13	13
Overall Study COMPLETED	9	13
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris

Baseline characteristics by cohort

Measure	Ziana Gel n=13 Participants Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks	Clindamycin Plus Tretinoin Applied Separately n=13 Participants Generic clindamycin 1% gel plus tretinoin 0.025% cream	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	20.1 years n=5 Participants	26.2 years n=7 Participants	23.1 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	13 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: All patients were analyzed up to end of treatment or last visit.

Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap

Outcome measures

Measure	Ziana Gel n=13 Participants Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks	Clindamycin Plus Tretinoin Applied Separately n=13 Participants Generic clindamycin 1% gel plus tretinoin 0.025% cream
Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne	88 Percent of doses Interval 13.0 to 115.0	61 Percent of doses Interval 8.0 to 95.0

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: All patients were analyzed up to end of treatment or last visit.

Outcome measures

Measure	Ziana Gel n=13 Participants Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks	Clindamycin Plus Tretinoin Applied Separately n=13 Participants Generic clindamycin 1% gel plus tretinoin 0.025% cream
The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count	-51 percentage of lesions Interval -80.0 to -23.0	-32 percentage of lesions Interval -66.0 to 2.0

Adverse Events

Ziana Gel

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Clindamycin Plus Tretinoin Applied Separately

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ziana Gel n=13 participants at risk Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks	Clindamycin Plus Tretinoin Applied Separately n=13 participants at risk Generic clindamycin 1% gel plus tretinoin 0.025% cream
Skin and subcutaneous tissue disorders Burning sensation on facial skin	7.7% 1/13 • Number of events 1	0.00% 0/13

Additional Information

Steven Feldman, MD, PhD

Wake Forest University Health Sciences

Phone: 336-716-3775

Email: sfeldman@wfubmc.edu

Results disclosure agreements

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