Comparison Between Topical Ketoconazole 2% Cream and Topical Adapalene 2% Cream in the Treatment of Mild Comedonal and Papulopustular Acne, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To study the efficacy of topical ketoconazole 2% cream in treatment of mild to moderate acne
研究概览
简要总结
objective: is to assess the efficacy of topical ketoconazole 2% cream in comparison with topical retinoid in the treatment of mild comedonal and papulopustular acne to determine if ketoconazole can be an alternative to topical retinoid with less side effects and more compliance.
Patients and methods: 52 patients with mild comedonal and papulopustular acne will be randomized into 2 groups and instructed to apply randomly either topical KTZ 2% cream or topical retinoid cream for a period of 12 weeks. Evaluation of response will be done by a blinded investigator
详细描述
Background: Acne vulgaris is a common chronic inflammatory skin disorder of pilosebaceous units that occurs predominantly in the skin of the face, upper chest and upper back. Acne is of multifactorial origin with four main pathophysiologic mechanisms: follicular hyperkeratinization with obstruction of pilosebaceous ducts, hormonal influences on sebum production, cutibacterium acnes (C. acnes) proliferation, immune host reaction and inflammation. Ketoconazole (KTZ) is an imidazolic anti-mycotic derivative that has been recently tried as a new line of treatment of mild acne. KTZ acts on microbial dysbiosis through the inhibitory effect on lipase activity of malassezia species and both antibiotic-susceptible and resistant C. acnes.
Objectives: our objective is to assess the efficacy of topical ketoconazole 2% cream in comparison with topical retinoid in the treatment of mild comedonal and papulopustular acne to determine if ketoconazole can be an alternative to topical retinoid with less side effects and more compliance.
Patients and methods: 52 patients with mild comedonal and papulopustular acne will be randomized into 2 groups. Group A will be advised to apply topical KTZ 2% cream twice daily on the whole face. Group B will be advised to apply topical retinoid cream once daily at night on the whole face except sensitive areas for a period of 12 weeks. Evaluation of response will be done by a blinded investigator 2 weeks after discontinuation of treatment using total lesion count, Global Evaluation of Acne (GEA) scores, Cardiff Acne Disability Index (CADI), and post-inflammatory hyperpigmentation (PIH) scores and patient satisfaction.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with mild comedonal or papulopustular acne with a GEA score from 1-2 on the face.
- •Both sexes.
- •Age: adolescents and adults.
- •Skin type 3 and 4.
排除标准
- •• Patients using, will use during the study, or discontinued less than 4 weeks before study baseline, prescribed or over-the counter topical therapies for the treatment of acne.
- •Patients using, will use during the study, or discontinued less than 4 weeks before study baseline, any facial procedures such as chemical peel, laser treatment or depilation in area of treatment application (except eyebrow shaping).
- •Patients with outdoor occupation, exposed to sun and heat.
- •Patients using, will use during study any cosmoceuticals.
- •Patients using, will use during the study, or discontinued less than 12 weeks before study baseline, systemic therapies for the treatment of acne or any other systemic treatments.
- •Patients with other special types of acne or conditions presenting with acne/acneiform eruption.
- •Irregular menstrual cycles or clinically suspected polycystic ovarian syndrome.
- •Patients with other facial rashes preventing the accurate assessment.
- •Known or suspected allergy to ingredients.
- •Pregnancy or lactation.
研究组 & 干预措施
mild acne patients who will apply topical ketoconazole 2%
they will apply topical KTZ 2% cream twice daily on the whole face for 12 weeks
干预措施: advised to apply topical ketoconazole 2% cream twice daily on the whole face. (Drug)
mild acne patients who will apply topical adapalene 2%
they will apply topical retinoid cream once daily at night on the whole face except sensitive areas for a period of 12 weeks
干预措施: topical adapalene to the face (Drug)
结局指标
主要结局
To study the efficacy of topical ketoconazole 2% cream in treatment of mild to moderate acne
时间窗: 3 months
results will be assessed using total lesion count
次要结局
- patient satisfaction(3 months)
- effect on post inflammatory hyperpigemntation(3 month)
研究者
Mona Mostafa Korany Mahmoud
lecturer of dermatology, Cairo university
Cairo University