Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris

Number of Participants With Adverse Events (AE)

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.

Time frame: From Baseline (Day 1) until Week 12

Change From Baseline in Systolic and Diastolic Blood Pressure

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

Time frame: Baseline (Day 1), Week 12

Change From Baseline in Heart Rate

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

Time frame: Baseline (Day 1), Week 12

Change From Baseline in Respiratory Rate

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

Time frame: Baseline (Day 1), Week 12

Change From Baseline in Body Temperature

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

Time frame: Baseline (Day 1), Week 12

Change From Baseline in Weight

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