NCT02755545.

Methods	This is a randomised, double‐blind, multicentre trial
Participants	Inclusion criteria of the trial Men and women age 21 to 45 years at the time of enrolment Individuals with mild to moderate acne (score of 2 to 3 on FDA Investigator's Global Assessment Scale 1) on the face Individuals with at least 5 inflammatory lesions Individuals with 10 ‐ 100 non‐inflammatory lesions Fitzpatrick skin type I‐VI Individuals willing to provide written informed consent including photo release, Health Insurance Portability and Accountability Act (HIPAA), and are able to read, speak, write, understand English Willing to withhold all facial treatments during the course of the study Individuals of child‐bearing potential who use an acceptable method of contraception throughout the study Subjects must be stable on any medication they are taking for at least 30 days Exclusion criteria of the trial Individuals diagnosed with allergies to topical acne products Individuals having a condition and/or disease of the skin that the Investigator deems inappropriate for participation Women who are nursing, pregnant, or planning to become pregnant during the study Individuals who have pre‐existing or dormant dermatologic conditions on the face which in the opinion of the investigator could interfere with the outcome of the study Individuals using or who have used any systemic medication considered to affect the course of acne, specifically, but not exclusively antibiotics or steroids within the last 30 days prior to entry into the study Individuals who are currently participating in another facial usage study or have participated in a clinical trial within 4 weeks prior to inclusion into the study Individuals with any planned surgeries and/or invasive medical procedures during the course of the study Individuals who started hormone replacement therapy (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study Individuals with facial sunburn or excessive tanned facial skin or that are not willing to avoid daily sun exposure on the face and the use of tanning beds or sunless tanning products for the duration of the study Individuals currently taking or have taken within the last 30 days oral or topical prescription medications for acne
Interventions	A: adapalene applied topically to the entire face or other affected area of the skin once daily (number of participants unclear) B: salicylic acid applied topically to affected area of the skin one to three times daily (number of participants unclear) Total estimated number of participants enrolled: 127
Outcomes	Primary outcome of the trial Percentage change in total lesions at week 12 from baseline (time frame: 12 weeks). Percentage change from baseline assessment at week 12, as assessed by investigator or designee Secondary outcomes of the trial Mean change in inflammatory lesion count (time frame: week 1, week 2, week 6, week 12, week 18, week 24). Mean change from baseline assessments at week 1, week 2, week 6, week 12, week 18, and week 24 as assessed by investigator or designee. Note that papules and pustules are classified as inflammatory acne lesions. Mean change in non‐inflammatory lesion count (time frame: week 1, week 2, week 6, week 12, week 18, week 24). Mean change from baseline assessments at week 1, week 2, week 6, week 12, week 18, and week 24 as assessed by investigator or designee. Note that open and closed comedones are classified as non‐inflammatory acne lesions. Mean change in Investigator's Global Assessment (IGA) (time frame: week 1, week 2, week 6, week 12, week 18, week 24). Mean change from baseline assessments at week 1, week 2, week 6, week 12, week 18, and week 24 as assessed by investigator or designee using the IGA scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe). Mean change in skin texture (digital images) (time frame: week 6, week 12, week 24). Mean change from baseline efficacy parameter assessment at week 6, week 12, and week 24 as assessed by trained evaluator. The efficacy parameter will be assessed globally using a modified Griffiths' 10‐point scale according to the following numerical definitions (half‐point scores may be used as necessary to more accurately describe the skin condition): 0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate; 7 to 9 = severe (worst possible condition) Mean change in skin tone evenness (digital images) (time frame: week 6, week 12, week 24). Mean change from baseline efficacy parameter assessment at week 6, week 12, and week 24 as assessed by trained evaluator. The efficacy parameter will be assessed globally using a modified Griffiths' 10‐point scale according to the following numerical definitions (half‐point scores may be used as necessary to more accurately describe the skin condition): 0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate; 7 to 9 = severe (worst possible condition) Mean change in skin clarity (digital images) (time frame: week 6, week 12, week 24). Mean change from baseline efficacy parameter assessment at week 6, week 12, and week 24 as assessed by trained evaluator. The efficacy parameter will be assessed globally using a modified Griffiths' 10‐point scale according to the following numerical definitions (half‐point scores may be used as necessary to more accurately describe the skin condition): 0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate; 7 to 9 = severe (worst possible condition) Mean change in overall skin complexion (digital images) (time frame: week 6, week 12, week 24). Mean change from baseline efficacy parameter assessment at week 6, week 12, and week 24 as assessed by trained evaluator. The efficacy parameter will be assessed globally using a modified Griffiths' 10‐point scale according to the following numerical definitions (half‐point scores may be used as necessary to more accurately describe the skin condition): 0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate; 7 to 9 = severe (worst possible condition) Subject self‐assessment questionnaire (time frame: week 1, week 2, week 6, week 12, week 24). Subjects will be asked to complete a self‐assessment questionnaire at week 1, week 2, week 6, week 12, and week 24. This questionnaire has a 5‐point Likert Response scale (1 = strongly agree; 5 = strongly disagree). Incidence of adverse events (time frame: 24 weeks) Mean change in erythema (tolerance) parameter (time frame: baseline, week 1, week 2, week 6, week 12, week 24). Investigator‐reported erythema evaluations will be performed at baseline and weeks 1, 2, 6, 12, and 24 using a 4‐point scale (0 = none; 3 = severe) Mean change in dryness (tolerance) parameter (time frame: baseline, week 1, week 2, week 6, week 12, week 24). Investigator‐reported dryness evaluations will be performed at baseline and weeks 1, 2, 6, 12, and 24 using a 4‐point scale (0 = none; 3 = severe) Mean change in scaling (tolerance) parameter (time frame: baseline, week 1, week 2, week 6, week 12, week 24). Investigator‐reported scaling evaluations will be performed at baseline and weeks 1, 2, 6, 12, and 24 using a 4‐point scale (0 = none; 3 = severe) Mean change in stinging/burning (tolerance) parameter (time frame: baseline, week 1, week 2, week 6, week 12, week 24). Subject‐reported stinging/burning evaluations will be performed at baseline and weeks 1, 2, 6, 12, and 24 using a 4‐point scale (0 = none; 3 = severe)
Notes	This study is sponsored by Galderma Laboratories, LP. Completed but no results posted.