A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris
NCT06063473
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
Sun Pharmaceutical Industries, Inc.
Start date
2023-02-22
Number of sites
- Summary
- To demonstrate therapeutic equivalence and safety of Trifarotene cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and AKLIEF® cream in the treatment of acne vulgaris
- Short title
- A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream 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.) and to AKLIEF® Cream (Trifarotene 0.005%,Galderma) and Both Active Treatments 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
- 2023-07-13
- First posted
- 2023-10-02
- Registry last updated
- 2023-10-02
- Primary completion date
- 2023-07-13
- Start date
- 2023-02-22
- Actual participants
- Participants
- 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
- NCT06063473
- ClinicalTrials.gov ID
- NCT06063473
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Single masking
- Masked roles
- Investigators
Sources for study design
Demonstration in Therapeutic Equivalence & Safety of the Investigational Product
Timeframe: Baseline to Week 12
Percent change in the inflammatory (papules and pustules) \& non-inflammatory (open and closed comedones) lesion counts
Sources for outcomes
- Sex
- All
- Age groups
- Children, Adults
- Minimum age
- 12 Years
- Maximum age
- 40 Years
- Healthy volunteers
- Yes
- Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects ages 12 to 17 years of age inclusive must have provided IRB approved written assent;
- Subjects must have a definite clinical diagnosis of acne vulgaris of 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.
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
- Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients.
- Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis,squamous cell carcinoma, eczema, acneiform eruptions caused by medications,steroid acne, steroid folliculitis, or bacterial folliculitis).
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