A Phase 1 interventional study of Trifarotene Cream 0.005% and AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG in Acne Vulgaris, sponsored by Taro Pharmaceuticals USA. Completed at 1 site in United States. Open to participants aged 12 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by Taro Pharmaceuticals USA (part of Sun Pharmaceutical Industries Limited) · Phase 1, Interventional, and Treatment
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.
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.
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's enrollment of 1,000 is above the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Taro Pharmaceuticals USA is the lead sponsor of 71 studies on the registry; none are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 1 (5%) have results posted.
First submitted after Taro Pharmaceuticals USA became part of Sun Pharmaceutical Industries Limited.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
Drug: Trifarotene Cream 0.005%
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
Drug: AKLIEF® 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.
Drug: AKLIEF® 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.
Drug: Placebo
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
Also known as: Test Product
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
Also known as: Reference Product
Drug page: Trifarotene
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
Also known as: Reference Product
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
Also known as: Vehicle
Demonstrate the therapeutic equivalence, efficacy and safety of the Investigational Product
Percentage change in the inflammatory (papules and pustules) \& non-inflammatory (open and closed comedones) of the lesion counts.
Time frame: Baseline to Week 12
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Trifarotene