A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne Vulgaris

Sun Pharmaceutical Industries, Inc.

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.04%; Drug: Placebo Control; Drug: Tretinoin Gel Microsphere, 0.04%

Study type: Interventional

Funder types: Industry

Identifiers

NCT07469228

TRTN-1620

Details and patient eligibility

About

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.

Full description

A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing 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.

Enrollment: 1,043 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,043 participants in 3 patient groups, including a placebo group

Tretinoin Gel Microsphere, 0.04%

Experimental group

Description:

The investigational product will be applied topically to the affected areas of the face lightly once daily at bedtime, avoiding the eyes, mouth, and other mucous membranes for 84 consecutive days.

Treatment:

Drug: Tretinoin Gel Microsphere, 0.04%

RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.04%

Active Comparator group

Description:

The investigational product will be applied topically to the affected areas of the face lightly once daily at bedtime, avoiding the eyes, mouth, and other mucous membranes for 84 consecutive days.

Treatment:

Drug: RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.04%

Placebo Control

Placebo Comparator group

Description:

The investigational product will be applied topically to the affected areas of the face lightly once daily at bedtime, avoiding the eyes, mouth, and other mucous membranes for 84 consecutive days.

Treatment:

Drug: Placebo Control