To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% and RLD in the Treatment of Acne Vulgaris

Taro Pharmaceuticals

Status and phase: Completed; Early Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: Vehicle of the test product; Drug: Tretinoin cream 0.1%; Drug: RETIN-A® Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT03427554

TRTC 1622

Details and patient eligibility

About

Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.

Full description

A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.1% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.1% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris

Enrollment: 455 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 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 be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.

Exclusion criteria

• Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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455 participants in 3 patient groups, including a placebo group

Tretinoin cream 0.1%

Experimental group

Description:

Once daily at home, to apply the entire affected areas of the face.

Treatment:

Drug: Tretinoin cream 0.1%

RETIN-A® Cream

Active Comparator group

Description:

Once daily at home, to apply the entire affected areas of the face.

Treatment:

Drug: RETIN-A® Cream

Vehicle of the test product

Placebo Comparator group

Description:

Once daily at home, to apply the entire affected areas of the face.

Treatment:

Drug: Vehicle of the test product