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Completed

NCT Number: NCT04007237

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).

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Key information

Conditions

Pityriasis Versicolor Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea Versicolor

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Puskesmas Kecamatan Pulo Gadung

Jakarta, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. mycology efficacy

    Time frame: 7 days

    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

  2. mycology efficacy

    Time frame: 14 days

    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

  3. compliance

    Time frame: 7 days

    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.

  4. compliance

    Time frame: 14 days

    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.

  5. side effect

    Time frame: 7 days

    based on clinical symptoms : itching, burning or stinging sensation. Assessed based on patient records in the diary and through interviews during control

  6. side effect

    Time frame: 14 days

    based on clinical symptoms : itching, burning or stinging sensation. Assessed based on patient records in the diary and through interviews during control

  7. cost-effectiveness

    Time frame: two weeks

    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

  8. recurrence

    Time frame: 1 month

    if the KOH test 20% give a positive result again

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 5, 2019
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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