Efficacy and Side Effects of 8% Sulphur-Aloe Vera Soap Versus Bland Soap as an Adjuvant of Ketoconazole 2% Shampoo for the Treatment of Pityriasis Versicolor: Open Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Scaling severity
研究概览
简要总结
Pityriasis versicolor (PV) is a superficial, mild, often chronic recurring infection of the skin caused by Malassezia species which is characterized by the formation of hypopigmented, hyperpigmented and/or erythematous macules. It commonly occurs on the trunk and proximal extremities, but can also be found on the entire body. Diagnosis of PV established based on clinical features and microscopic examination with potassium hydroxide. The goals of PV treatment are: to eradicate the hyphae, disappearance of clinical signs and symptoms, to lessen recurrences, and improve patient's quality of life. Topical antifungal remains first line therapy and search for an ideal topical agent of PV continue. Various studies reported combining more than one topical agents can increase the efficacy, thus result in faster mycological cure.
详细描述
Pityriasis versicolor commonly has extensive and irregular pattern/distribution on the body. Therefore, topical antifungal such as ketoconazole, usually given in shampoo or solution form to cover large surface area. Many studies reported adverse effects of ketoconazole shampoo including pruritus, dry skin, and allergic contact dermatitis. Non-spesific keratolytic agent, such as sulphur, used for PV work by desquamation of the entire superficial skin layer and eliminating the fungi in the process. It also could enhance the penetration of ketoconazole into the stratum corneum, increasing its potency. Aloe vera (A. vera) contains acetylated mannan that acts as humectant and increase water content in stratum corneum. The combination of sulphur and A. vera in form of a soap as adjuvant to ketoconazole shampoo potentially will result in synergistic effect, faster mycological cure, and less adverse effects. There are limited data of sulphur and A.vera soap as an adjuvant PV treatment to ketoconazole shampoo. As a result of limited data, our trial is looked forward to assess the efficacy and adverse effect of sulphur and A.vera soap as an adjuvant PV treatment to ketoconazole shampoo.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age 18-65 years
- •Diagnosed as PV based on clinical features, microscopic examination using 10% potassium hydroxide, and Wood's lamp
排除标准
- •Pregnant or lactating women
- •PV with concurrent skin conditions (dermatitis or skin lesions in form of vesicles or blister or pustules or erosions or excoriation) with body surface area >30%
- •Use of topical antifungal and/or corticosteroid 14 days prior to study entry
- •Use of systemic antifungal and/or corticosteroid 30 days prior to study entry
- •History of allergy to shampoo or soap containing ketoconazole, sodium lauryl sulphate, sulphur, A. vera, charcoal powder, glycerin, or perfume.
研究组 & 干预措施
8% sulphur and A. vera soap and ketoconazole 2% shampoo
Twenty-one patients will be given the combination of 8% sulphur and A. vera soap applied to the entire body surface (excluding face), left on for five minutes and then washed off. This was applied twice daily for four weeks.
Along with the soap or placebo, patients will receive 2% ketoconazole shampoo, left on for five minutes and then washed off. This was applied thrice weekly for a week
干预措施: 8% sulphur and A. vera soap (Drug)
Bland soap and ketoconazole 2% shampoo
Twenty-one patients will be given bland soap applied to the entire body surface (excluding face), left on for five minutes and then washed off. This was applied twice daily for four weeks.
Along with the soap or placebo, patients will receive 2% ketoconazole shampoo, left on for five minutes and then washed off. This was applied thrice weekly for a week.
干预措施: 8% sulphur and A. vera soap (Drug)
结局指标
主要结局
Scaling severity
时间窗: 28 days
Patients will be evaluated for scaling severity according to the following scale: 0 = no scaling; 1 = mild distribution of scaling; 2 = moderate distribution of scaling; 3 = severe, extensive distribution of scaling.
Clinical assessment of pruritus
时间窗: 28 days
A visual analogue score (VAS) will be used to assess pruritus according to the following scale: 0 = no pruritus; 1-3 = mild pruritus; 4-6 = moderate pruritus; 7-10 = severe pruritus.
Mycological cure
时间窗: 28 days
Evaluation of mycological cure examined by microscopic examination using 10% potassium hydroxide. A cellophane tape will be used for taking scale lesions.
次要结局
- Wood's lamp(28 days)
- Skin hydration(28 days)
- Skin pH (potential hydrogen)(28 days)