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

NCT ID: NCT06305637

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-04
• Study Completion Date: 2024-02-10

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.

Conditions

Tinea Versicolor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ketoconazole Shampoo, 2%

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Ketoconazole Shampoo, 2% (Reference Standard)

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Test Product; Reference Product; Vehicle

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalie Yantovskiy

Role: STUDY_DIRECTOR

Taro Pharmaceuticals, Inc.

Locations

Taro

Hawthorne, New York, United States

Countries

United States

Other Identifiers

KTCS-2302

Identifier Type: -

Identifier Source: org_study_id