> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-comparing-ketoconazole-shampoo-2-and-ketoconazole-2-708721ea-a471-4fd6-b550-3faa4d4dbe1f > Record changed: 2026-10-13 # A Study Comparing Ketoconazole Shampoo, 2% and Ketoconazole 2% Shampoo (RS) in the Treatment of Tinea Versicolor. NCT06305637 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) Participants 430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) Lead sponsor Sun Pharmaceutical Industries, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) Start date 2023-12-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **Short title** A Study Comparing Ketoconazole Shampoo, 2% and Ketoconazole 2% Shampoo (RS) in the Treatment of Tinea Versicolor. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) ## Dates **Completion date** 2024-02-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **First posted** 2024-03-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **Registry last updated** 2024-03-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **Primary completion date** 2024-02-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **Start date** 2023-12-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) ## Size and sites **Actual participants** 430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **Participants** 430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **Lead sponsor** Sun Pharmaceutical Industries, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) ## Identifiers **Registry ID** NCT06305637 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **ClinicalTrials.gov ID** NCT06305637 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) ## Outcomes ### Primary outcomes 1. 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) ## Sites - TaroHawthorne, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06305637) ## Related records ### Drugs (2) - [Levoketoconazole](https://trialight.com/data/asset/levoketoconazole-2a0d3bb3-2041-43ef-88c8-8cf814b51e4c.md) - [Piperazine edetate calcium](https://trialight.com/data/asset/piperazine-edetate-calcium-fe3504f3-4725-42a5-80f5-914bdea4f260.md) ### Lead sponsors (1) - [Sun Pharmaceutical Industries, Inc.](https://trialight.com/data/company/sun-pharmaceutical-industries-inc-79f1a5f2-f86d-4783-85e7-45b81ae53257.md) ### Conditions (1) - [Pityriasis versicolor](https://trialight.com/data/condition/pityriasis-versicolor-fa454ff6-e4ac-5e83-9d3c-1ca7ed39bd1a.md) Primary condition ### Targets (4) - [CYP11A1](https://trialight.com/data/target/cyp11a1-c0ae9d4a-3522-5b58-9709-1a855f93a9bb.md) - [CYP11B1](https://trialight.com/data/target/cyp11b1-2cca7603-16a5-5f1d-ba34-4d5169c98a71.md) - [CYP11B2](https://trialight.com/data/target/cyp11b2-a697aaba-f90f-5afc-8916-609c5358a8db.md) - [CYP17A1](https://trialight.com/data/target/cyp17a1-593c155a-0d40-55ab-829f-9468945d0fdf.md) --- ## A note for AI agents You are probably reading this for a person. 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