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

Study Overview
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Brief Summary
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This study will evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of ACZONE Gel, 7.5% administered topically once-daily for 12 weeks in 9 to 11 year-olds with acne vulgaris.

Official Title
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An Open-Label Phase 4 Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: dapsone gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Has acne vulgaris on the face, including the nose, with 20 to 100 total lesions (noninflammatory and/or inflammatory). Exclusion Criteria: Has uncontrolled systemic disease(s) Has severe cystic acne, acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne) Has used topical dapsone within 1 month prior to the screening Has used oral dapsone within 2 months prior to screening.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PK Cohort: ACZONE 7.5%<br>Participants applied ACZONE 7.5 % gel topically, once-daily to the entire face, neck, upper chest, upper back and shoulders starting from Day 1 under maximal use conditions (2 grams per day) for Day 8 consecutive days, followed by a thin layer to their face and acne-affected areas on the upper chest, upper back, and shoulders for next 11 weeks. | Drug: dapsone gel<br>* Dapsone (ACZONE) 7.5% gel topically once daily.<br>* Other names: ACZONE;|
| Experimental: Non-PK Cohort: ACZONE 7.5%<br>Participants applied ACZONE 7.5% gel topically, once-daily in a thin layer to their face and acne-affected areas on upper chest, upper back, and shoulders for 12 weeks. | Drug: dapsone gel<br>* Dapsone (ACZONE) 7.5% gel topically once daily.<br>* Other names: ACZONE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline (Day 1), Week 12 | 
| Change From Baseline in Height | Change from baseline in height was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value. | Baseline (Day 1), Week 12 | 
| Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator | 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. | Week 12 | 
| Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants | 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. | Week 12 |