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

DV-202309.02

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.

2023-08-25

2023-12-31

2024-01-31

Completed

Early phase I

42

Inclusion Criteria: 1. Male or female 2. Age 18-65 years 3. Diagnosed as PV based on clinical features, microscopic examination using 10% potassium hydroxide, and Wood's lamp Exclusion Criteria: 1. Pregnant or lactating women 2. 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% 3. Use of topical antifungal and/or corticosteroid 14 days prior to study entry 4. Use of systemic antifungal and/or corticosteroid 30 days prior to study entry 5. History of allergy to shampoo or soap containing ketoconazole, sodium lauryl sulphate, sulphur, A. vera, charcoal powder, glycerin, or perfume.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 42, 'type': 'ACTUAL'}}

2024-03-26