Potential Combination Topical Therapy of Acne Vulgaris: a Randomized Controlled Trial Comparing Efficacy of DAP/FLU Micro-emulsion vs. Standard Therapy of Adapalene.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety assessment by the recording of patient-reported adverse events
研究概览
简要总结
The investigators propose a randomized, double-blind control trial study to evaluate the efficacy and safety of the optimized topical combination ME of the investigated drugs in the treatment of acne vulgaris containing DAP-FLU in comparison with standard therapy of Adapalene at Mansoura University Dermatology and Andrology Outpatient Clinic.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females age 12 or older
- •Clinical diagnosis of mild to moderate facial acne vulgaris defined as:
- •≥ 5 inflammatory lesions, and;
- •≥ 10 non-inflammatory lesions, and;
- •Willing to refrain from using any treatments, other than the investigational product, for acne present on the face. This includes the use of antibiotics for the treatment of acne.
- •Willing and able to provide informed consent and to comply with the study protocol.
排除标准
- •Women were excluded if they were pregnant, nursing, or planning a pregnancy as were men with facial hair that would interfere with the assessments.
- •Continuous or planned use of tanning booths or excessive sun exposure, in the opinion of the Investigator.
- •Treatment with systemic corticosteroids within 28 days prior to baseline.
- •Two or more active nodular lesions.
- •Use of androgen receptor blockers (such as spironolactone or flutamide) in the 7 days prior to randomization.
研究组 & 干预措施
Adapalene .1% gel
Acne vulgaris patients treated with standard therapy of Adapalene.
干预措施: Adapalene .1% gel (Drug)
DAP/FLU ME
Acne vulgaris patients treated with the optimized topical combination ME contain DAP-FLU.
干预措施: DAP-FLU ME (Drug)
结局指标
主要结局
Safety assessment by the recording of patient-reported adverse events
时间窗: 8 Weeks
Throughout the study
Michaelson's acne severity index (ASI)
时间窗: 8 Weeks
It's evaluated by counting non-inflammatory lesions (open and closed comedones) and inflammatory lesions (papules, pustules and nodules of at least 5 mm in diameter), and calculated as follows: ASI = (comedones x 0.5) + (papules x 1) + (pustules x 2) + (nodules x 3).
次要结局
未报告次要终点
研究者
Amgad E Salem, pHD
Assistant lecturer, pharmaceutical department, faculty of pharmacy
Mansoura University