A Study Comparing Ketoconazole Shampoo, 2% and Ketoconazole 2% Shampoo (RS) in the Treatment of Tinea Versicolor.
NCT06305637
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
Sun Pharmaceutical Industries, Inc.
Start date
2023-12-04
Number of sites
- 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.
- Short title
- A Study Comparing Ketoconazole Shampoo, 2% and Ketoconazole 2% Shampoo (RS) in the Treatment of Tinea Versicolor.
- Official title
- 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.
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2024-02-10
- First posted
- 2024-03-12
- Registry last updated
- 2024-03-12
- Primary completion date
- 2024-02-10
- Start date
- 2023-12-04
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06305637
- ClinicalTrials.gov ID
- NCT06305637
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Triple masking
- Masked roles
- Participants, Care providers, Investigators
Sources for study design
To demonstrate the therapeutic equivalence and safety of the Investigational Product
Timeframe: Day 28 Visit
Proportion of subjects with treatment success/cure
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- Yes
- 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.
- 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.
Sources for eligibility
- TaroHawthorne, United States
Sources for sites
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Pityriasis versicolor Primary condition