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Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo

NCT01135069 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2014-10-27

Study results available
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Summary

The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.

Conditions

Interventions

DRUG

Tretinoin microsphere 0.1%

Treatment of acne vulgaris

DRUG

Brand Retin-A Micro tretinoin microsphere gel 0.1%

Treatment of acne vulgaris

DRUG

placebo microsphere gel

treatment of acne vulgaris

Sponsors & Collaborators

  • Spear Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Krunal Patel, MD · Moore Clinical Research

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
2009-10-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01135069 on ClinicalTrials.gov