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

A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Ketoconazole Shampoo, 2% to Ketoconazole Shampoo, 2% (RS) and Both Active Treatments to a Placebo Control in the Treatment of Tinea Versicolor.

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.

Study Overview

• Status: Completed
• Conditions: Tinea Versicolor
• Intervention / Treatment: Drug: Ketoconazole Shampoo, 2%; Drug: Ketoconazole Shampoo, 2% (Reference Standard); Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 430
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Hawthorne, New York, United States, 10532
      • Taro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Test Product
Active Comparator: 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.	Drug: 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.; Other Names: Reference Product
Placebo Comparator: Placebo Control; 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.	Drug: 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.; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate the therapeutic equivalence and safety of the Investigational Product	Proportion of subjects with treatment success/cure	Day 28 Visit

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA
• Investigators: Study Director: Natalie Yantovskiy, Taro Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Actual): February 10, 2024
• Study Completion (Actual): February 10, 2024

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Dermatomycoses; Tinea; Tinea Versicolor; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Ketoconazole
• Other Study ID Numbers: KTCS-2302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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