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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Accepted

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).

Conditions

• Pityriasis Versicolor

Interventions

Type	Name	Description
DRUG	shampoo with different composition	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.

Timeline

• Start date: 2018-09-01
• Primary completion: 2018-12-30
• Completion: 2018-12-30
• First posted: 2019-07-05
• Last updated: 2019-07-05

Locations

1 site across 1 country: Indonesia

Regulatory

• FDA-regulated drug study