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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 20
- 主要终点
- Number of Participants With Adverse Events (AE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has acne vulgaris on the face, including the nose, with 20 to 100 total lesions (noninflammatory and/or inflammatory).
排除标准
- •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.
研究组 & 干预措施
PK Cohort: ACZONE 7.5%
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.
干预措施: dapsone gel (Drug)
Non-PK Cohort: ACZONE 7.5%
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.
干预措施: dapsone gel (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AE)
时间窗: From Baseline (Day 1) until Week 12
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.
Change From Baseline in Systolic and Diastolic Blood Pressure
时间窗: Baseline (Day 1), Week 12
Change from baseline in systolic and diastolic blood pressure was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.
Change From Baseline in Heart Rate
时间窗: Baseline (Day 1), Week 12
Change from baseline in heart rate was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.
Change From Baseline in Respiratory Rate
时间窗: Baseline (Day 1), Week 12
Change from baseline in respiratory rate was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Change From Baseline in Body Temperature
时间窗: Baseline (Day 1), Week 12
Change from baseline in body temperature was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Change From Baseline in Weight
时间窗: Baseline (Day 1), Week 12
Change from baseline in weight was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Change From Baseline in Height
时间窗: Baseline (Day 1), Week 12
Change from baseline in height was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator
时间窗: Week 12
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.
Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants
时间窗: Week 12
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.
次要结局
未报告次要终点