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

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Tinea Versicolor

Treatments: Drug: Ketoconazole Shampoo, 2% (Reference Standard); Drug: Ketoconazole Shampoo, 2%; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06305637

KTCS-2302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 430 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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430 participants in 3 patient groups, including a placebo group

Ketoconazole Shampoo, 2%

Experimental group

Description:

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.

Treatment:

Drug: Ketoconazole Shampoo, 2%

Ketoconazole Shampoo, 2% (Reference Standard)

Active Comparator group

Description:

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.

Treatment:

Drug: Ketoconazole Shampoo, 2% (Reference Standard)

Placebo Control

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo