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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

455 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-21

Study Completion Date

2018-01-26

Brief Summary

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

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Detailed Description

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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

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Tretinoin cream 0.1%

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

Group Type EXPERIMENTAL

Tretinoin cream 0.1%

Intervention Type DRUG

Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)

RETIN-A® Cream

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

Group Type ACTIVE_COMPARATOR

RETIN-A® Cream

Intervention Type DRUG

RETIN-A® (Tretinoin) Cream (Valeant)

Vehicle of the test product

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

Group Type PLACEBO_COMPARATOR

Vehicle of the test product

Intervention Type DRUG

Vehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)

Interventions

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Tretinoin cream 0.1%

Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)

Intervention Type DRUG

RETIN-A® Cream

RETIN-A® (Tretinoin) Cream (Valeant)

Intervention Type DRUG

Vehicle of the test product

Vehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)

Intervention Type DRUG

Other Intervention Names

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Tretinoin Tretinoin Placebo

Eligibility Criteria

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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 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.