Acne Vulgaris
Conditions
Brief 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.
Detailed description
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing 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.
Interventions
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
DRUGAKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
DRUGAKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
DRUGPlacebo
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate the therapeutic equivalence, efficacy and safety of the Investigational Product | Baseline to Week 12 | Percentage change in the inflammatory (papules and pustules) & non-inflammatory (open and closed comedones) of the lesion counts. |
Countries
United States
Outcome results
None listed