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

NCT06305637 | Completed Phase 1 FDA Drug

• 1 other identifier: KTCS-2302
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinea Versicolor

Outcome Measures

Primary Outcomes (1)

• To demonstrate the therapeutic equivalence and safety of the Investigational Product

  Proportion of subjects with treatment success/cure

  Day 28 Visit

Study Arms (3)

Ketoconazole Shampoo, 2%

EXPERIMENTAL

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%

Ketoconazole Shampoo, 2% (Reference Standard)

ACTIVE COMPARATOR

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)

Placebo Control

PLACEBO COMPARATOR

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

Interventions

Ketoconazole Shampoo, 2% DRUG

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.

Also known as: Test Product

Ketoconazole Shampoo, 2%

Ketoconazole Shampoo, 2% (Reference Standard) DRUG

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.

Also known as: Reference Product

Ketoconazole Shampoo, 2% (Reference Standard)

Placebo DRUG

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.

Also known as: Vehicle

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or non-pregnant female aged ≥ 18 years
• Subjects must have provided IRB approved written informed consent.
• Subjects must have clinical diagnosis of tinea versicolor.
• Subjects must be willing to refrain from using all other tinea versicolor medications or antifungals during the study, other than the investigational product.
• 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.

You may not qualify if:

• Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
• Subjects with a history of hypersensitivity or allergy to ketoconazole, other imidazole antifungals, and/or any of the study medication ingredients.
• 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).
• Treatment for tinea versicolor within the past 6 months that had been unresponsive to prescription topical or oral antifungals.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (1)

Taro

Hawthorne, New York, 10532, United States

Location

MeSH Terms

Conditions

Tinea Versicolor

Interventions

Reference Standards

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Weights and Measures; Investigative Techniques

Study Officials

• Natalie Yantovskiy

  Taro Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: December 4, 2023
• Primary Completion: February 10, 2024
• Study Completion: February 10, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)