The Comparative Assessment of Mycological Efficacy, Safety, Recurrence, and Cost-effectiveness of Selenium Sulfide 1.8% Shampoo Versus Ketoconazole 2% Shampoo in Pityriasis Versicolor: a Double-blind Randomized Controlled Trial

• Status: Completed
• Trial end date: 2018-12-30
• Target enrollment: 0
• Participant gender: All

Summary

There are several topical treatment for Pityriasis Versicolor including ketoconazole and selenium sulfide. Ketoconazole is a broad spectrum anti-fungal drug from imidazole group that has been reported to be effective in PV. The study aimed to reveal the mycological efficacy, safety, recurrence and cost-effectiveness of selenium sulfide 1.8% shampoo (SeS2) and ketoconazole 2% shampoo in the treatment of pityriasis versicolor. A double blind randomized controlled trial was performed in patients with PV during September-December 2018. Patients who involved in this study were allocated to SeS2 or ketoconazole 2% based on block randomization. Physical examinations, scale provocation test, Wood lamp and potassium hydroxide (KOH) examination were conducted to evaluate the treatment response and side effects on 7th - 14th day. Intention to treat analysis was performed in this study. cost-effectiveness was analyzed by Incremental Cost-Effectiveness Ratio (ICER).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indonesia University
• Treatments: Ketoconazole; Selenium; Selenium disulfide

Criteria

Inclusion Criteria:

• Having PV characteristic skin lesions,proven by 20% KOH scraping test and Parker Blue-Black® ink, with the founding of short hyphae and group spores or short hyphae only

• willing to participate in the study by signing the written informed consent

• Subjects under the age of 18 with permission from parents or guardians.

Exclusion Criteria:

• A history of hypersensitivity to the ingredients of the shampoo tested.

• Having skin abnormalities with impaired skin integrity

• In the treatment of topical anti-fungal therapy for less than two weeks or systemic anti-fungal for less than one month.

• Pregnancy and breastfeeding.

• Patients with PV lesions on the face.