MedTrace Logo

A Bioavailability Study of DFD-03 Compared to Tazorac® in Patients With Moderate Acne Vulgaris

NCT03599193 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2021-03-01

Study results available
· View outcomes & findings →

Summary

This was a multicenter, randomized, multiple-dose, laboratory-blinded, open-label, 2-arm, parallel-arm study in subjects with moderate acne vulgaris.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Tazarotene Lotion, 0.1%

DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off

DRUG

Tazarotene Cream, 0.1%

Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Anirudh Gautam · Dr. Reddy's Laboratories Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-04
Primary Completion
2018-04-30
Completion
2018-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03599193 on ClinicalTrials.gov