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

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).

Study Overview

• Status: Completed
• Conditions: Pityriasis Versicolor
• Intervention / Treatment: Drug: shampoo with different composition

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia
    • Puskesmas Kecamatan Pulo Gadung

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 56 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Selsun Shampoo (SeS2 shampoo); 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	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.
Active Comparator: Ketoconazole shampoo; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mycology efficacy	skin scrapping with KOH test 20% and Parker Blue-Black® ink with the founding of short hyphae and group spores or short hypha only as a positive result	7 days
mycology efficacy	skin scrapping with KOH test 20% and Parker Blue-Black® ink with the founding of short hyphae and group spores or short hypha only as a positive result	14 days
compliance	the number of day in which a participant using the shampoo which was assigned for minimum 5 days or more and the remaining volume of shampoo does not exceed 25 ml.	7 days
compliance	the number of day in which a participant using the shampoo which was assigned for minimum 5 days or more and the remaining volume of shampoo does not exceed 25 ml.	14 days
side effect	based on clinical symptoms : itching, burning or stinging sensation. Assessed based on patient records in the diary and through interviews during control	7 days
side effect	based on clinical symptoms : itching, burning or stinging sensation. Assessed based on patient records in the diary and through interviews during control	14 days
cost-effectiveness	Cost calculations include administrative fees (registration and consultation of doctors), laboratory examinations, medical expenses and compensation for side effects adjusted for the duration of therapy. The results of the calculation of costs obtained are then linked to the negative outcome difference (KOH is still positive) or the value of absolute risk reduction (ARR) on day 14. So that cost efficacy is seen from Incremental Cost-Effectiveness Ratio	two weeks
recurrence	if the KOH test 20% give a positive result again	1 month

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: June 15, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: ketoconazole; mycological efficacy; selenium disulfide 1,8%; Pityriasis versicolor
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Infections; Disease Attributes; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Skin Diseases, Papulosquamous; Mycoses; Dermatomycoses; Recurrence; Tinea Versicolor; Pityriasis
• Other Study ID Numbers: efficacy - PV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes