A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris
NCT06733402
Phase
Phase 1
Recruitment status
Completed
Participants
1,000
Lead sponsor
Sun Pharmaceutical Industries, Inc.
Start date
2024-06-20
Number of sites
- Summary
- To demonstrate the efficacy, therapeutic equivalence and safety of Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and US Reference Listed Drug, Canadian Reference Product over the placebo control in the treatment of acne vulgaris.
- Short title
- A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris
- Official title
- A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and Each Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris.
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2024-11-09
- First posted
- 2024-12-13
- Registry last updated
- 2024-12-13
- Primary completion date
- 2024-06-20
- Start date
- 2024-06-20
- Actual participants
- 1,000
- Participants
- 1,000
- 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
- NCT06733402
- ClinicalTrials.gov ID
- NCT06733402
- 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
Demonstrate the therapeutic equivalence, efficacy and safety of the Investigational Product
Timeframe: Baseline to Week 12
Percentage change in the inflammatory (papules and pustules) \& non-inflammatory (open and closed comedones) of the lesion counts.
Sources for outcomes
- Sex
- All
- Age groups
- Children, Adults
- Minimum age
- 12 Years
- Maximum age
- 40 Years
- Healthy volunteers
- No
- Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3 or 4 as per the Investigator's Global Assessment (IGA).
- Subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face.
- Subjects must be willing to refrain from using all other topical acne medications or antibiotics for acne vulgaris during the 12-week treatment period, other than the investigational product.
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Subjects with a history of hypersensitivity or allergy to Trifarotene, retinoids and/or any of the study medication ingredients.
- Subjects with excessive facial hair (e.g. beards, sideburns, mustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
- Subjects with a baseline irritation score of 3 = severe (marked, intense).
Sources for eligibility
- Taro Pharmaceuticals USA Inc.Hawthorne, United States
Sources for sites
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Acne Primary condition