NCT07015931已完成1 期
Efficacy of 0.025% Retinoic Acid Cream Compared to 0.1% Adapalene Cream on Mild Acne Vulgaris, as Well as Safety Profile and Post-Acne Sequelae in Fitzpatrick Skin Types III-V: A Randomized Double-Blind Clinical Trial Using the Split-Face Method
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Comparison of the percentage reduction in total acne lesions between the 0.025% tretinoin cream group and the 0.1% adapalene cream group
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness, safety profile, and post-acne sequelae of 0.025% retinoic acid cream versus 0.1% adapalene cream for mild acne vulgaris in individuals with Fitzpatrick skin types III-V.
Main research questions are:
- How does 0.025% retinoic acid cream compare to 0.1% adapalene cream in reducing the total number of acne lesions in patients with mild acne vulgaris and Fitzpatrick skin types III-V?
- What is the severity of adverse effects that occur on the facial side treated with 0.1% adapalene cream and the facial side treated with 0.025% retinoic acid cream in patients with mild acne vulgaris and Fitzpatrick skin types III-V?
- What is the severity of post-inflammatory hyperpigmentation (PIH) that occurs on the facial side treated with 0.1% adapalene cream and the facial side treated with 0.025% retinoic acid cream in patients with mild acne vulgaris and Fitzpatrick skin types III-V?
- What is the severity of post-acne erythema (PAE) that occurs on the facial side treated with 0.1% adapalene cream and the facial side treated with 0.025% retinoic acid cream in patients with mild acne vulgaris and Fitzpatrick skin types III-V?
- What is the quantity, type, and severity of post-acne scarring (PAS) that occurs on the facial side treated with 0.1% adapalene cream and the facial side treated with 0.025% retinoic acid cream in patients with mild acne vulgaris and Fitzpatrick skin types III-V?
Participants will:
- Undergo baseline assessments, including acne lesion count, hyperpigmentation index, Clinician Erythema Assessment (CEA) scale, and post-acne scarring grading on each facial side.
- Apply 0.025% retinoic acid cream and 0.1% adapalene cream on different facial sides as per randomization, every night for 12 weeks.
- Record daily adverse effects per facial side, lesion manipulation frequency, and sun exposure duration
- Attend follow-up visits every 4 weeks for acne lesion count, hyperpigmentation index, CEA scale, post-acne scarring grading, and assessment of adverse effect severity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of mild acne vulgaris, defined as fewer than 20 comedonal lesions, fewer than 15 inflammatory lesions, or a total lesion count of 30 or less, with a difference in total lesion count between the two sides of the face ≤ 5 lesions.
- •Minimum age of 15 years.
- •Indonesian individuals with Fitzpatrick skin types III-V.
- •Willing to participate in the study by signing an informed consent form.
排除标准
- •History of routine application of topical agents containing active ingredients on the face within the past 2 weeks.
- •History of oral antibiotic use within the past 2 weeks.
- •History of systemic retinoid use within the past 3 months.
- •Currently pregnant or breastfeeding.
- •Using oral contraceptives at the time of assessment.
- •Presence of other dermatologic conditions on the face aside from acne vulgaris.
- •Having sensitive facial skin classified as rosacea-type, stinging-type, or allergic-type.
- •Unwilling to discontinue topical active agent therapy that has been used routinely for at least 2 weeks prior to study participation.
研究组 & 干预措施
Treatment with 0.025% Retinoic Acid Cream (Split-Face Design)
Experimental
Participants will apply 0.025% retinoic acid cream half finger tip unit on one randomized side of the face every night for 12 weeks.
干预措施: retinoic acid cream 0.025% (Drug)
Treatment with 0.1% Adapalene Cream (Split-Face Design)
Experimental
Participants will apply 0.1% adapalene cream half finger tip unit on one randomized side of the face every night for 12 weeks.
干预措施: adapalene cream 0.1% (Drug)
结局指标
主要结局
Comparison of the percentage reduction in total acne lesions between the 0.025% tretinoin cream group and the 0.1% adapalene cream group
时间窗: from enrollment to the end of treatment at 12 weeks
The percentage reduction was calculated by comparing the total number of lesions at 12 weeks to baseline counts
次要结局
- Severity profile of adverse effects(from enrollment to the end of treatment at 12 weeks)
- Hyperpigmentation index profile(from enrollment to the end of treatment at 12 weeks)
- Post acne erythema profile(from enrollment to the end of treatment at 12 weeks)
- Profile of post-acne scar type(from enrollment to the end of treatment at 12 weeks)
- Severity profile of post acne scarring(from enrollment to the end of treatment at 12 weeks)
研究者
研究点 (1)
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