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

NCT03433378 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2018-05-18

No results posted yet for this study

Summary

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

Conditions

  • Acne Vulgaris

Interventions

DRUG

Tretinoin cream, 0.05%

Tretinoin cream, 0.05%

DRUG

RETIN-A® (tretinoin) cream, 0.05%

RETIN-A® (tretinoin) cream, 0.05%

DRUG

Vehicle of the test product

Vehicle of the test product

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Natalie Yantovskiy · Taro Pharmaceuticals Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-04
Primary Completion
2018-01-26
Completion
2018-01-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03433378 on ClinicalTrials.gov