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

University of Indonesia (UI)

Status and phase: Completed; Phase 4

Conditions: Pityriasis Versicolor

Treatments: Drug: shampoo with different composition

Study type: Interventional

Funder types: Other

Identifiers

NCT04007237

efficacy - PV

Details and patient eligibility

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).

Enrollment: 100 patients

Sex: All

Ages: 12 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Selsun Shampoo (SeS2 shampoo)

Experimental group

Description:

Subject were given the SeS2 1.8% shampoo for 2 weeks. They should use it everyday, 10ml each time for 10 minutes. Evaluation was weekly and note for side effects and compliance

Treatment:

Drug: shampoo with different composition

Ketoconazole shampoo

Active Comparator group

Description:

Subject were given the Ketoconazole 2% shampoo for 2 weeks. They should use it everyday, 10ml each time for 10 minutes. Evaluation was weekly and note for side effects and compliance

Treatment:

Drug: shampoo with different composition