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

NCT03427554 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 455

Last updated 2018-05-18

No results posted yet for this study

Summary

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

Conditions

  • Acne Vulgaris

Interventions

DRUG

Tretinoin cream 0.1%

Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)

DRUG

RETIN-A® Cream

RETIN-A® (Tretinoin) Cream (Valeant)

DRUG

Vehicle of the test product

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

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Zaidoon A Al-Zubaidy · Catawba Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2018-01-26
Completion
2018-01-26

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 NCT03427554 on ClinicalTrials.gov