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

Pityriasis Versicolor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04007237
• Other study ID #: efficacy - PV
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: July 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pityriasis Versicolor
• Recurrence
• Tinea Versicolor

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Puskesmas Kecamatan Pulo Gadung	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	recurrence	if the KOH test 20% give a positive result again	1 month