drugset / Trial / NCT04007237

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

NCT04007237

Phase 4 Completed 100 enrolled Indonesia University
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2018-09-01
Primary completion
2018-12-30
Completion
2018-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketoconazole Small molecule 2 % Topical
Subject Ketoconazole Small molecule 10 ml Topical
Subject selenium sulfide Small molecule 1.8 % Topical
Subject selenium sulfide Small molecule 10 ml Topical

Indications