Trial Outcomes & Findings for A Clinical Trial to Evaluate the Efficacy of Two Acne Treatments (NCT NCT02755545)

Last Updated: 2023-12-28

Results Overview

Percent change from baseline in total lesions at week 12 was assessed by investigator or designee. Investigator or designee counted and recorded the number of open comedones, closed comedones, papules, and pustules on each subject's face. Lesions were counted globally on the following facial locations/quadrants: forehead, left cheek, chin, and right cheek. Each of the following lesion types were analyzed separately for forehead, left cheek, chin, right cheek, and the total of the 4 areas: * Inflammatory acne lesions (sum of papules and pustules) * Non-inflammatory acne lesions (sum of open comedones and closed comedones) * Total lesion counts (sum of inflammatory and non-inflammatory acne lesions counts)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

127 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2023-12-28

Participant Flow

Participant milestones

Participant milestones
Measure	Adapalene Subjects who were randomized to adapalene and used it once-daily.	Salicylic Acid Subjects who were randomized to salicylic acid and used it as directed per the OTC monograph.
Overall Study STARTED	62	65
Overall Study COMPLETED	43	44
Overall Study NOT COMPLETED	19	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adapalene n=62 Participants Subjects who were randomized to adapalene	Salicylic Acid n=65 Participants Subjects who were randomized to salicylic acid.	Total n=127 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=58 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	0 Participants n=59 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	0 Participants n=117 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.
Age, Categorical Between 18 and 65 years	58 Participants n=58 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	59 Participants n=59 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	117 Participants n=117 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.
Age, Categorical >=65 years	0 Participants n=58 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	0 Participants n=59 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	0 Participants n=117 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.
Sex: Female, Male Female	49 Participants n=58 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	56 Participants n=59 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	105 Participants n=117 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.
Sex: Female, Male Male	9 Participants n=58 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	3 Participants n=59 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	12 Participants n=117 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=58 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	2 Participants n=59 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	3 Participants n=117 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.
Race (NIH/OMB) Asian	3 Participants n=58 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	2 Participants n=59 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	5 Participants n=117 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=58 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	0 Participants n=59 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	0 Participants n=117 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.
Race (NIH/OMB) Black or African American	24 Participants n=58 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	24 Participants n=59 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	48 Participants n=117 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.
Race (NIH/OMB) White	26 Participants n=58 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	24 Participants n=59 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	50 Participants n=117 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.
Race (NIH/OMB) More than one race	0 Participants n=58 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	0 Participants n=59 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	0 Participants n=117 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=58 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	7 Participants n=59 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.	11 Participants n=117 Participants • Some subjects were enrolled, but excluded from analysis as they were withdrawn from the study before drug dispensed.
Region of Enrollment United States	62 participants n=62 Participants	65 participants n=65 Participants	127 participants n=127 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: A total of 127 were enrolled, but only 117 were included in the efficacy analysis.

Outcome measures

Outcome measures
Measure	Adapalene n=58 Participants Subjects treated with adapalene.	Salicylic Acid n=59 Participants Subjects treated with salicylic acid.
Percent Change From Baseline in Total Lesions at Week 12 Open comedones	-17.1 Percent change in lesions Standard Deviation 117.4	-45.6 Percent change in lesions Standard Deviation 61.1
Percent Change From Baseline in Total Lesions at Week 12 Closed comedones	-13.0 Percent change in lesions Standard Deviation 165.5	7.6 Percent change in lesions Standard Deviation 153.8
Percent Change From Baseline in Total Lesions at Week 12 Papules	-4.2 Percent change in lesions Standard Deviation 71.7	6.4 Percent change in lesions Standard Deviation 83.5
Percent Change From Baseline in Total Lesions at Week 12 Pustules	-30.1 Percent change in lesions Standard Deviation 153.2	-18.2 Percent change in lesions Standard Deviation 113.5
Percent Change From Baseline in Total Lesions at Week 12 Inflammatory acne lesions	-10.0 Percent change in lesions Standard Deviation 67.0	1.1 Percent change in lesions Standard Deviation 72.6
Percent Change From Baseline in Total Lesions at Week 12 Non-inflammatory acne lesions	-34.7 Percent change in lesions Standard Deviation 41.8	-22.8 Percent change in lesions Standard Deviation 43.0
Percent Change From Baseline in Total Lesions at Week 12 Total lesion counts	-28.3 Percent change in lesions Standard Deviation 38.2	-17.5 Percent change in lesions Standard Deviation 36.7

Adverse Events

Adapalene

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Salicylic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Adapalene n=62 participants at risk Subjects who were randomized to adapalene	Salicylic Acid n=65 participants at risk Subjects who were randomized to salicylic acid.
Skin and subcutaneous tissue disorders Dry skin	3.2% 2/62 • Number of events 2 • Collected over the duration of the study up to 24 weeks.	0.00% 0/65 • Collected over the duration of the study up to 24 weeks.

Additional Information

Director, Medical Affairs and Clinical Development

Galderma

Phone: 8179615325

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place