MedTrace Logo

Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo

NCT01243450 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 958

Last updated 2020-01-03

Study results available
· View outcomes & findings →

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

Treatment of acne

DRUG

placebo

treatment of acne

Sponsors & Collaborators

  • Spear Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • William Cunningham, MD · Cu-Tech

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT01243450 on ClinicalTrials.gov