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Pityriasis Versicolor

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

Sponsored by Indonesia University

About this trial

Last updated 7 years ago

Study ID

efficacy - PV

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

12 to 60 Years
All Sexes

Trial Timing

Ended 7 years ago

What is this trial about?

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).

What are the participation requirements?

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.