Trial Outcomes & Findings for Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide (NCT NCT03122457)

Results Overview

Treatment Success defined as a score of 0 (clear) to 1 (almost clear) at day 99 (final study visit) by acne PGA scoring system. Full PGA scale from 0-5, with lower score indicating better drug efficacy

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Day 99

Results posted on

2020-09-04

Participant Flow

Recruitment from July 2015 through August 2019 Please confirm the date of the first enrollment (month, day, year) Please confirm the date of the last study visit or the last date that data was collected (month, day, year)

Participant milestones

Participant milestones
Measure	Lidamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combo lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days
Overall Study STARTED	22
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Lidamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combo lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days
Overall Study Withdrawal by Subject	6

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combo n=22 Participants lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days
Age, Categorical <=18 years	0 Participants n=22 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=22 Participants
Age, Categorical >=65 years	0 Participants n=22 Participants
Sex: Female, Male Female	22 Participants n=22 Participants
Sex: Female, Male Male	0 Participants n=22 Participants

PRIMARY outcome

Timeframe: Day 99

Treatment Success defined as a score of 0 (clear) to 1 (almost clear) at day 99 (final study visit) by acne PGA scoring system. Full PGA scale from 0-5, with lower score indicating better drug efficacy

Outcome measures

Outcome measures
Measure	Lidamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combo n=22 Participants lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days
PGA Score	0.53 score on a scale Standard Error 0.29

SECONDARY outcome

Timeframe: Day 99

Safety/drug-tolerance evaluated by subject-reported adverse events as well as physician evaluated erythema, scaling, drying, and stinging/burning on a 0-3 point scale, where 0=none and 3=severe.

Outcome measures

Outcome measures
Measure	Lidamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combo n=22 Participants lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days
Adverse Event Severity 0	22 Participants
Adverse Event Severity 1	0 Participants
Adverse Event Severity 2	0 Participants
Adverse Event Severity 3	0 Participants

Adverse Events

Lidamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anjali Vekaria

Icahn School of Medicine at Mount Sinai

Phone: 212-241-3288

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60