To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris

A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TRETINOIN CREAM, 0.05% to RETIN-A® (TRETINOIN) CREAM, 0.05% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03433378

Enrollment

700

Registered

2018-02-14

Start date

2017-08-04

Completion date

2018-01-26

Last updated

2018-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Brief summary

Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.

Detailed description

A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.05% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.05% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris

Interventions

DRUGTretinoin cream, 0.05%

Tretinoin cream, 0.05%

DRUGRETIN-A® (tretinoin) cream, 0.05%

RETIN-A® (tretinoin) cream, 0.05%

DRUGVehicle of the test product

Vehicle of the test product

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

Bioequivalence

Eligibility

Sex/Gender

ALL

Age

12 Years to 40 Years

Healthy volunteers

Yes

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) (per Table 1 below).

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.

Design outcomes

Primary

Measure	Time frame	Description
Demonstration of Bioequivalence	12 weeks	Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026