A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in … (NCT07469228) | Clinical Trial Compass
CompletedPhase 1
A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne Vulgaris
United States1,043 participantsStarted 2025-08-04
Plain-language summary
To demonstrate the efficacy, therapeutic equivalence and safety of tretinoin gel microsphere, 0.04% (Sun Pharmaceutical Industries, Inc.) and RETIN-A MICRO ® (tretinoin) gel microsphere, 0.04% (Reference Listed Drug) in the treatment of acne vulgaris.
Who can participate
Age range12 Years – 40 Years
SexALL
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Inclusion Criteria:
* 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 must have provided IRB approved written informed consent.
* 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.
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 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).
* Subjects with a baseline irritation score of 3 = severe (marked, intense).
* Subjects with eczematous skin.
What they're measuring
1
Demonstrate & evaluate the therapeutic, equivalence and safety of the investigational product