A Study Comparing Ketoconazole Shampoo, 2% and Ketoconazole 2% Shampoo (RS) in the Treatment of Tinea Versicolor.

Phase 1

Completed

• Conditions: Tinea Versicolor
• Interventions: Drug: Ketoconazole Shampoo, 2% (Reference Standard); Drug: Ketoconazole Shampoo, 2%; Drug: Placebo

• Registration Number: NCT06305637
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

To demonstrate the efficacy, therapeutic equivalence and safety of Ketoconazole Shampoo, 2% (Taro Pharmaceuticals U.S.A., Inc.) and Ketoconazole 2% Shampoo (Reference Standard) in the treatment of tinea versicolor.

Detailed Description

A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Ketoconazole Shampoo, 2% (Taro Pharmaceuticals U.S.A, Inc.) to Ketoconazole Shampoo, 2% (Reference Standard) and both active treatments to a placebo control in the treatment of tinea versicolor.

Study Timeline

• Study Start: 2023-12-04
• Primary Completion: 2024-02-10
• Study Completion: 2024-02-10
• Status Verified: 2024-03
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

1. Healthy male or non-pregnant female aged ≥ 18 years
2. Subjects must have provided IRB approved written informed consent.
3. Subjects must have clinical diagnosis of tinea versicolor.
4. Subjects must be willing to refrain from using all other tinea versicolor medications or antifungals during the study, other than the investigational product.
5. Female Subjects of childbearing potential (excluding women who are premenarchal, surgically sterilized (by hysterectomy) or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.

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Exclusion Criteria

1. Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
2. Subjects with a history of hypersensitivity or allergy to ketoconazole, other imidazole antifungals, and/or any of the study medication ingredients.
3. Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of tinea versicolor (e.g., vitiligo, pityriasis alba, post inflammatory hypopigmentation and hyperpigmentation, seborrheic dermatitis, pityriasis rosea, guttate psoriasis, tinea corporis, nummular eczema, secondary syphilis, confluent reticulated papillomatosis of Gougerot and Carteaud, and mycosis fungoides).
4. Treatment for tinea versicolor within the past 6 months that had been unresponsive to prescription topical or oral antifungals.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketoconazole Shampoo, 2% (Reference Standard)	Ketoconazole Shampoo, 2% (Reference Standard)	The investigational product was applied on a single occasion topically to the damp skin of the affected area and a wide margin surrounding this area for 5 minutes and then rinsed off with water.
Ketoconazole Shampoo, 2%	Ketoconazole Shampoo, 2%	The investigational product was applied on a single occasion topically to the damp skin of the affected area and a wide margin surrounding this area for 5 minutes and then rinsed off with water.
Placebo Control	Placebo	The investigational product was applied on a single occasion topically to the damp skin of the affected area and a wide margin surrounding this area for 5 minutes and then rinsed off with water.

Primary Outcome Measures

Name	Time	Method
To demonstrate the therapeutic equivalence and safety of the Investigational Product	Day 28 Visit	Proportion of subjects with treatment success/cure

Trial Locations

Locations (1)

Taro; 🇺🇸 Hawthorne, New York, United States