An AE was defined as "any untoward medical occurrence in a clinical trial participant (regardless of the administration of the study drug and its causal relationship to it). An AE could therefore, be any unfavorable and unintended medical occurrence during the participant's participation in the trial, including deterioration of a pre-existing medical condition, an abnormal clinically significant finding in a laboratory assessment, or an abnormal clinically significant finding in the physical examination or vital sign.

Safety population included all participants who received at least one application of study drug.

Change from baseline in systolic and diastolic blood pressure was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.

Safety population included all participants who received at least one application of study drug.

Change from baseline in heart rate was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.

Safety population included all participants who received at least one application of study drug.

Change from baseline in respiratory rate was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.

Safety population included all participants who received at least one application of study drug.

Change from baseline in body temperature was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.

Safety population included all participants who received at least one application of study drug.

Change from baseline in weight was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.

Safety population included all participants who received at least one application of study drug.

Change from baseline in height was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.

Safety population included all participants who received at least one application of study drug.

Local dermal tolerability was evaluated by investigator in terms of presence and absence of dryness, scaling and erythema symptoms and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point scale of 0 - 3, where 0 = none (no dryness, scaling and erythema) and 3 = severe (marked roughness, heavy scale production and intense redness). The higher score indicated severe symptoms.

Safety population included all participants who received at least one application of study drug. Here, "number analyzed" signifies number of participants with available data for the specified category.

Local dermal tolerability was evaluated by participants in terms of presence and absence of prickling pain sensation immediately after (within 5 minutes of dosing) and its severity in the areas of body where medication was applied (face). Stinging/burning symptoms were graded on a 4-point scale of 0 - 3 where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling/stinging sensation; not really bothersome), 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome), 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort). The higher score indicated severe symptoms.

Safety population included all participants who received at least one application of study drug. Here, "number analyzed" signifies number of participants with available data for the specified category.

The mean plasma peak (10 hours postdose) concentrations of dapsone, dapsone hydroxylamine and N-acetyl dapsone were reported.

Pharmacokinetic (PK) population included all participants who received applications of study drug for at least 8 days under maximal use conditions and had evaluable blood samples for PK analysis.

The trough plasma concentrations of Dapsone, Dapsone hydroxylamine and N-acetyl dapsone were reported.

Pharmacokinetic (PK) population included all participants who received applications of study drug for at least 8 days under maximal use conditions and had evaluable blood samples for PK analysis.

Inflammatory lesion counts were the sum of counts of the following lesion types (face only): Papule - a small, red, solid elevation less than (<) 1.0 centimeter (cm) in diameter; Pustule - a small, circumscribed elevation of the skin that contains yellow-white exudate; Nodule - a circumscribed, elevated, solid lesion generally more than 1.0 cm in diameter with palpable depth; Cyst - a smooth, dome-shaped, elevated, freely moveable, skin-colored, round to ovoid lesion greater than 0.7 cm in diameter. Change from baseline was calculated by subtracting post-dose value from baseline value.

Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment. This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).

Inflammatory lesion counts were the sum of counts of the following lesion types (face only): Papule - a small, red, solid elevation less than 1.0 cm in diameter; Pustule - a small, circumscribed elevation of the skin that contains yellow-white exudate; Nodule - a circumscribed, elevated, solid lesion generally more than 1.0 cm in diameter with palpable depth; Cyst - a smooth, dome-shaped, elevated, freely moveable, skin colored, round to ovoid lesion greater than 0.7 cm in diameter.

Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment.This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).

Non-inflammatory lesion counts were defined as the sum of counts of the following lesion type (face only): open comedone - a pigmented dilated pilosebaceous orifice (blackhead); closed comedone - a tiny white papule (whitehead). Change from baseline was be calculated by subtracting post-dose value from the baseline value.

Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment. This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).

Noninflammatory lesion counts were defined as the sum of counts of the following lesion type (face only): open comedone - a pigmented dilated pilosebaceous orifice (blackhead); closed comedone - a tiny white papule (whitehead).

Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment. This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).

Total lesion counts were defined as the sum of inflammatory lesion counts and noninflammatory lesion counts (face only). Change from baseline was be calculated by subtracting post-dose value from the baseline value.

Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment.This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).

Total lesion counts were defined as the sum of inflammatory lesion counts and noninflammatory lesion counts (face only).

Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment. This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).

Overall severity of acne vulgaris was evaluated by using a 5-point IGA scale: Clear (0) - (no comedones; papules or pustules, residual hyperpigmentation and erythema may be present); Almost clear (1) - (rare comedones; no more than a few small papules and pustules); Mild (2) - (easily recognizable comedones in limited numbers; +/- presence of small papules and pustules); Moderate (3) - (many comedones; +/- easily recognizable small and medium-sized papules; no nodules or cysts; Severe (4) - (widespread and numerous comedones; many small, medium-sized and large papules and pustules; nodules or cysts may or may not be present).

Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment. This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).

Overall severity of acne vulgaris was evaluated by using a 5-point IGA scale: Clear (0) - (no comedones; papules or pustules, residual hyperpigmentation and erythema may be present); Almost clear (1) - (rare comedones; no more than a few small papules and pustules); Mild (2) - (easily recognizable comedones in limited numbers; +/- presence of small papules and pustules); Moderate (3) - (many comedones; +/- easily recognizable small and medium-sized papules; no nodules or cysts; Severe (4) - (widespread and numerous comedones; many small, medium-sized and large papules and pustules; nodules or cysts may or may not be present).

Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment.This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).