Long-term Study of Efficacy/Safety of Adapalene/Benzoyl Peroxide Topical Gel in Acne Vulgaris Subjects

Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse.

Time frame: At Month 12

Population: ITT population included all participants who were enrolled and to whom medication was dispensed. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse.

Time frame: At Month 6

Population: ITT population included all participants who were enrolled and to whom medication was dispensed. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Percent change in inflammatory, noninflammatory and total lesions at Month 12 was measured from baseline lesions. The noninflammatory lesion count was the sum of open comedones (a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead) and closed comedones (a mass of sebaceous material that is impacted behind a closed follicular orifice (whitehead). The inflammatory lesion count was the sum of papules (a small, solid elevation less than 1.0 cm in diameter) and pustules (a small, circumscribed elevation of the skin that contains yellow-white exudate). The total lesion count was the sum of inflammatory and noninflammatory lesions. Missing adapalene and benzoyl peroxide data were imputed using last observation carried forward (LOCF).

Time frame: Baseline, Month 12 LOCF

Population: ITT population included all participants who were enrolled and treated to whom medication was dispensed.

Clinical laboratory parameters included hematology, blood chemistry, urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported.

Time frame: Baseline up to Month 14

Population: The safety population was defined as all participants enrolled who had applied study medication at least once.

Local tolerability assessment for dryness (brittle and/or tight sensation) was graded on a 0 (none) to 3 (severe) scale as follows; none (0- no dryness), mild (1- slight but definite roughness), moderate (2 -moderate roughness), severe (3- marked roughness).

Time frame: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12

Population: The safety population was defined as all participants enrolled who had applied study medication at least once. Here, 'number analyzed' signifies participants who were evaluable at each post-baseline timepoint.

Local tolerability assessment for erythema (abnormal redness of the skin) was graded on a 0 (none) to 3 (severe) scale as follows; none (0- no erythema), mild (1- slight pinkness present), moderate (2- definite redness, easily recognized), severe (3- intense redness). The worst severity scores were generally mild or moderate, and rarely severe.

Time frame: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12

Population: The safety population was defined as all participants enrolled who had applied study medication at least once. Here, 'number analyzed' signifies participants who were evaluable at each post-baseline timepoint.

Local tolerability assessment for scaling (abnormal shedding of the stratum corneum) was graded on a 0 (none) to 3 (severe) scale as follow; none (0- no Scaling), mild (1- barely perceptible shedding, noticeable only on light scratching or rubbing), moderate (2- obvious but not profuse shedding), severe (3- heavy scale production).

Time frame: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12

Population: The safety population was defined as all participants enrolled who had applied study medication at least once. Here, 'number analyzed' signifies participants who were evaluable at each post-baseline timepoint.

Local tolerability assessment for stinging/burning \[prickling pain sensation immediately after (within 5 minutes of) dosing\] was graded on a 0 (none) to 3 (severe) scale as follows; none (0- no stinging/ burning), mild (1- slight warm, tingling/stinging sensation; not really bothersome), moderate (2- definite warm, tingling/stinging sensation that is somewhat), severe (3- hot, tingling/stinging sensation that has caused definite discomfort).

Time frame: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12

Population: ITT safety population was defined as all participants enrolled who had applied study medication at least once. Here, 'number analyzed' signifies participants who were evaluable at each post-baseline timepoint.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Time frame: Baseline up to Month 14

Population: The safety population was defined as all participants enrolled who had applied study medication at least once.