A Randomized, Double Blind, Three- arm, Placebo Controlled, Parallel Design, Multi-Center, Clinical Endpoint Bioequivalence Study of Ketoconazole Shampoo 2% (Test Product) Compared with Ketoconazole Shampoo 2% (Reference Product) In Adult Subjects with Tinea Versicolor.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 535
- Locations
- 23
- Primary Endpoint
- •To demonstrate clinical endpoint bioequivalence of Ketoconazole Shampoo 2% For Topical Application of Novitium Pharma (a subsidiary of ANI Pharmaceuticals INC.) with Ketoconazole Shampoo 2% For Topical Application of Perrigo in subjects with Tinea Versicolor.
Study Overview
Brief Summary
A Randomized, Double Blind, Three- arm, Placebo Controlled, Parallel Design, Multi-Center, Clinical Endpoint Bioequivalence Study in Adult Male and Female (non-pregnant & non-lactating) Subjects with Tinea Versicolor.
The primary objective of this study is to demonstrate clinical endpoint bioequivalence between the test and reference products and to test the superiority of the two active treatments to Placebo in human adult Male and Female (non-pregnant & non-lactating) Subjects with Tinea Versicolor. The secondary objective is to assess the safety of Investigational Products in human adult Male and Female (non-pregnant & non-lactating) Subjects with Tinea Versicolor.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Male or non-pregnant, non-lactating female, with the age limit of ≥18 years to ≤65 years.
- •2.Subject able to communicate effectively and provide written informed consent.
- •3.Female subject of childbearing potential must NOT be pregnant or lactating at Visit 01 (negative urine pregnancy test).
- •4.Be either post-menopausal or surgically sterile, abstinent, or, if sexually active, willing to practice an effective method of birth control before entry and throughout the study.
- •5.Clinical diagnosis of Tinea Versicolor.
- •Presence of infection with Malassezia furfur (Pityrosporum orbiculare or P.
- •ovale) as confirmed by a positive KOH cellophane tape test (Annexure 04) showing the characteristic “spaghetti and meatballs†appearance of the round budding yeast cells and short hyphae.
- •6.Sum of clinical signs and symptoms score of target lesion at least 4; in addition, target lesion must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either pruritis or scaling.
- •7.Subjects willing to abide by the study requirements and also give consent to take photos of the infected area (s).
Exclusion Criteria
- •1.Pregnant or lactating or planning to become pregnant during the study period.
- •2.Use of Antipruritics, including Antihistamines, within 72 hours prior to entry into the study.
- •3.Use of topical Corticosteroid, Antibiotics or Antifungal therapy within 02 weeks prior to entry into the study.
- •4.Use of systemic (e.g., oral or injectable) Corticosteroid, Antibiotics or Antifungal therapy within 01 month prior to entry into the study.
- •5.Use of oral Terbinafine or Itraconazole within 02 months prior to entry into the study.
- •6.Use of immunosuppressive medication or radiation therapy within 03 months prior to entry into the study.
- •7.Use of any other topical products applied to the target site, Systemic (e.g., oral or injectable) Antibiotics or Antifungals, Systemic Corticosteroid, Antipruritics, including Antihistamines, within 24 hours of study visits.
- •8.History of dermatophyte infections unresponsive to systemic or topical antifungal drugs 9.History of alcohol or other substance abuse within the last one year.
- •10.Known hypersensitivity to Ketoconazole, other Imidazoles or to any component of the formulation, particularly sulfites.
- •11.Receipt of any drug as part of a research study within 30 days before Visit
- •12.Previous participation in a similar study.
- •13.Institutionalized subject.
- •14.Inability to understand the requirements of the study and the relative information or are unable or unwilling to comply with the study protocol.
- •15.Any other condition of the subject, which, in the opinion of the investigator, which is likely to interfere with the study treatment and assessments.
- •16.Other severe acute or chronic medical 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 judgement of the investigator, would make the subject inappropriate for entry into the trial.
Outcomes
Primary Outcomes
•To demonstrate clinical endpoint bioequivalence of Ketoconazole Shampoo 2% For Topical Application of Novitium Pharma (a subsidiary of ANI Pharmaceuticals INC.) with Ketoconazole Shampoo 2% For Topical Application of Perrigo in subjects with Tinea Versicolor.
Time Frame: •To demonstrate clinical endpoint bioequivalence of Ketoconazole Shampoo 2% For Topical Application of Novitium Pharma (a subsidiary of ANI Pharmaceuticals INC.) with Ketoconazole Shampoo 2% For Topical Application of Perrigo in subjects with Tinea Versicolor. | •To evaluate the superiority of Ketoconazole Shampoo 2% For Topical Application and Ketoconazole Shampoo 2% For Topical Application of Perrigo over placebo in subjects with Tinea Versicolor. | in 4 weeks
•To evaluate the superiority of Ketoconazole Shampoo 2% For Topical Application and Ketoconazole Shampoo 2% For Topical Application of Perrigo over placebo in subjects with Tinea Versicolor.
Time Frame: •To demonstrate clinical endpoint bioequivalence of Ketoconazole Shampoo 2% For Topical Application of Novitium Pharma (a subsidiary of ANI Pharmaceuticals INC.) with Ketoconazole Shampoo 2% For Topical Application of Perrigo in subjects with Tinea Versicolor. | •To evaluate the superiority of Ketoconazole Shampoo 2% For Topical Application and Ketoconazole Shampoo 2% For Topical Application of Perrigo over placebo in subjects with Tinea Versicolor. | in 4 weeks
Secondary Outcomes
- To assess the safety and tolerability of Investigational Products(Safety will be assessed for total study duration 4 weeks)