A Study Comparing Tretinoin Gel Microsphere, 0.1% and RETIN-A MICRO ® Gel Microsphere, 0.1% in the Treatment of Acne Vulgaris

Taro Pharmaceuticals

Status and phase: Completed; Early Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: Tretinoin Gel Microsphere, 0.1%; Drug: Placebo Control; Drug: RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04883736

TRTN-1619

Details and patient eligibility

About

To demonstrate the therapeutic equivalence and safety of Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) in the treatment of acne vulgaris.

Full description

A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) in the treatment of acne vulgaris.

Enrollment: 973 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: Accepts Healthy Volunteers

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 (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)

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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973 participants in 3 patient groups, including a placebo group

Tretinoin Gel Microsphere, 0.1%

Experimental group

Description:

The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.

Treatment:

Drug: Tretinoin Gel Microsphere, 0.1%

RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1%

Active Comparator group

Description:

The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.

Treatment:

Drug: RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1%

Placebo Control

Placebo Comparator group

Description:

The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.

Treatment:

Drug: Placebo Control