CTRI/2022/03/041524 [Registered on: 31/03/2022] Trial Registered Prospectively
Last Modified On:
17/10/2023
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
A Clinical Study to Evaluate the Efficacy and Safety of Ketoconazole Shampoo in Subjects with Tinea Versicolor.
Scientific Title of Study
A Multicenter, Randomized, Double-Blind, Three- Arm, Placebo-Controlled, Parallel Design, Study to Evaluate the Efficacy and Safety of Ketoconazole 2% Shampoo of Cadila Healthcare Limited with Ketoconazole Shampoo, 2% of Perrigo New York Inc. in Subjects with Tinea Versicolor
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
Protocol No.: C2A00867 Version: 2.0 Date: 14 Jun 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Vice President - Global Clinical Operations
Affiliation
Cliantha Research Limited
Address
Department Clinical Trials, Room no. 01, 2nd floor, 6, Arista@Eight Corporate House, Near Satyam House, Behind Rajpath Club, Bodakdev, Ahmadabad-380054, Gujarat, India.
Ahmadabad GUJARAT 380054 India
Phone
079-66219555
Fax
079-66219549
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Ankesh Barnwal
Designation
Associate director-I, Clinical Trial Medical Services
Affiliation
Cliantha Research Limited
Address
Department Clinical Trials, Room no. 01, 2nd floor, 6, Arista@Eight Corporate House, Near Satyam House, Behind Rajpath Club, Bodakdev, Ahmadabad-380054, Gujarat, India
Ahmadabad GUJARAT 380054 India
Phone
079-66219545
Fax
079-66219549
Email
abarnwal@cliantha.com
Details of Contact Person Public Query
Name
Mr Hitesh Maheshwari
Designation
Associate Director- Clinical Trial
Affiliation
Cliantha Research Limited
Address
Department Clinical Trials, 4th floor, 6,
Arista@Eight Corporate House, Near Satyam House,
Behind Rajpath Club, Bodakdev, Ahmadabad-380054,
Gujarat, India.
Ahmadabad GUJARAT 380054 India
Phone
079-66219577
Fax
079-66219549
Email
hmaheshwari@cliantha.com
Source of Monetary or Material Support
Cadila Healthcare Limited, Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad – 382 481, India.
Primary Sponsor
Name
Cadila Healthcare Limited
Address
Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad – 382 481, India.
The drug application is for a single occasion on the day/evening of Visit 1 (Day 0).
Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area. Lather, leave in place for 5 minutes, and then rinse off with water. Avoid study product contact with the eye.
Comparator Agent
Ketoconazole Shampoo, 2%
The drug application is for a single occasion on the day/evening of Visit 1 (Day 0).
Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area. Lather, leave in place for 5 minutes, and then rinse off with water. Avoid study product contact with the eye.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
Subject will be eligible for inclusion in this study only if all of the following criteria apply:
1 Male or non-pregnant or non-lactating female subjects between 18 years of age or above.
2 Subjects with a clinical diagnosis of tinea versicolor and both of the following
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
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 give written informed consent prior to study entry.
4. Female of childbearing potential, have a negative urine pregnancy test at the baseline visit 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.
ExclusionCriteria
Details
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 of tinea versicolor.
2. Use of any systemic or topical antifungals, corticosteroids or immunosuppressive drugs within 30 days prior to baseline visit.
3. 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 baseline visit or used antihistamines that may interfere with the subjects ability to experience cutaneous sensations within 24 hours prior to baseline visit unless on a stable dose of antihistamine for at least 30 days.
4. Any known hypersensitivity or allergy to ketoconazole or other imidazole antifungals or other shampoos, soaps or cosmetics.
5. Treatment for tinea versicolor within the past six months that has been unresponsive to prescription topical or oral antifungals.
6. History of alcohol or other substance abuse within the last one year.
7. Any other clinical investigation using experimental drug within past 30 days of prior to baseline visit.
8. Institutionalized subject.
9. Live in the same household as currently enrolled subject.
10. Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities 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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
To evaluate bioequivalence (with clinical endpoint) of test product (Ketoconazole 2% Shampoo) of Cadila Healthcare Limited with reference product (Ketoconazole Shampoo, 2%) of Perrigo New York Inc. in subjects with tinea versicolor.
2. To evaluate the superiority of test and reference product with placebo in subjects with tinea versicolor.
Day 28 (±4 days)
Secondary Outcome
Outcome
TimePoints
To assess safety and tolerability of study treatments.
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Day 28 (±4 days).
Target Sample Size
Total Sample Size="425" Sample Size from India="425" Final Enrollment numbers achieved (Total)= "425" Final Enrollment numbers achieved (India)="425"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
A study is Multicenter, Randomized, Double-Blind, Three- Arm, Placebo-Controlled, Parallel Design Study. This clinical trial intended to Evaluate the Efficacy and Safety of Ketoconazole 2% Shampoo of Cadila Healthcare Limited with Ketoconazole Shampoo, 2% of Perrigo New York Inc. in Subjects with Tinea Versicolor.