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

NCT04007237 | Completed Phase 4 FDA Drug

• 1 other identifier: efficacy - PV
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

mycological efficacy; ketoconazole; selenium disulfide 1,8%; Pityriasis versicolor

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Selsun Shampoo (SeS2 shampoo)

EXPERIMENTAL

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

Ketoconazole shampoo

ACTIVE COMPARATOR

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

Interventions

shampoo with different composition DRUG

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.

Ketoconazole shampoo; Selsun Shampoo (SeS2 shampoo)

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Puskesmas Kecamatan Pulo Gadung

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Tinea Versicolor

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind randomized clinical trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2019
• First Posted: July 5, 2019
• Study Start: September 1, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

ID (1)