A Bioequivalence study to Evaluate the Efficacy and Safety of Ketoconazole Shampoo in Subjects with Tinea Versicolor.
- Conditions
- Health Condition 1: B360- Pityriasis versicolor
- Registration Number
- CTRI/2024/01/061161
- Lead Sponsor
- Encube Ethicals Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Subject will be eligible for inclusion in this study only if all of the following criteria apply:
1. Male or non-pregnant, non-lactating female subjects of 18 to 65 years of age.
2. Subject with a clinical diagnosis of tinea versicolor and both of the following:
a. A combined severity score of at least 4, with at least one of the following signs and symptoms rated at least 2, using the following scale:
Signs/symptoms Scale
desquamation/scaling - 0 equals to absent
pruritus/itching - 1 equals to mild
erythema - 2 equals to moderate & 3 equal to severe
b. Presence of infection with Malassezia furfur (Pityrosporum orbiculare or P. ovale) confirmed by a positive KOH cellophane tape test showing the characteristic spaghetti and meatballs ? appearance of the round budding yeast cells and short hyphae.
3. Subject able to understand the investigational nature of this study and provide written informed consent prior to screening.
4. Female of childbearing potential, have a negative urine pregnancy test and willing to use an acceptable form of birth control including abstinence during the study.
5. Able to comply with study requirements in the opinion of Investigator.
6. Agree not to take a shower, bath, or swim, for at least 4 hours before all study visits
7. Agree to use only non-medicated shampoos and soaps during the entire study period.
Subject will not be eligible for inclusion in this study if any of the following criteria apply:
1. Has recent history or evidence of other fungal infections, including oral, vaginal or chronic mucocutaneous candidiasis, systemic fungal infections or dermatophyte infections that may interfere with assessment of tinea versicolor.
2. Use of any systemic antifungals (oral or injectable), corticosteroids or
immunosuppressive drugs within 30 days prior to randomization.
3. Any eye disease that could be irritated by shampoo.
4. Subject with known history of uncontrolled diabetes (based on HbA1c report [greater than 7%] within last 3 months) or expected change in anti-diabetic medication during study or within last 1 month.
5. Use of any prescription or over the counter (OTC), topical antifungal, anti-pruritus, corticosteroid, selenium sulfide or zinc pyrithione preparations within 14 days prior to randomization or used antihistamines that may interfere with the subjects ability to experience cutaneous sensations within 24 hours prior to randomization, unless on a stable dose of antihistamine for at least 30 days.
6. Any known hypersensitivity or allergy to ketoconazole or any other inactive ingredients used in the study products or other imidazole antifungals or other shampoos, soaps or cosmetics.
7. Treatment for tinea versicolor within the past six months that has been unresponsive to prescription topical or oral antifungals.
8. History of alcohol or other substance abuse within the last one year.
9. Any other clinical investigation using experimental drug within past 30 days of prior to randomization.
10. Institutionalized subject.
11. Live in the same household as currently enrolled subject or in the same household of a subject who has previously participated in the study.
12. Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities or on any medication that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into the trial.
13. Inability to understand the requirements of the study and the study information or is unable or unwilling to comply with the study protocol.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To evaluate bioequivalence (with clinical endpoint) of test product (Ketoconazole 2% Shampoo) of Encube Ethicals Private Limited, India with reference product (Ketoconazole Shampoo, 2%) of Padagis (Perrigo) Allegan, MI 49010 in subjects with tinea versicolor. <br/ ><br>2. To evaluate superiority of test and reference product with placebo in subjects with tinea versicolor. <br/ ><br>Timepoint: 4 Week(±4 days)
- Secondary Outcome Measures
Name Time Method 1. To assess safety and tolerability of study treatments. <br/ ><br> <br/ ><br>Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). <br/ ><br>Timepoint: 4 Week(±4 days)