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A Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks

NCT03292640 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 547

Last updated 2021-03-01

Study results available
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Summary

Enrollment of subjects with mild to moderate facial acne vulgaris.

Co-Primary efficacy endpoints included:

* Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face
* Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the face
* Proportion of subjects with a clinical response of "success" at Week 12 for lesions on the face. Success based on IGA is defined as an IGA score of 0 (Clear) or 1 (Almost clear) at Week 12 with at least a 2-grade reduction from Baseline.

Conditions

  • Acne Vulgaris

Interventions

DRUG

DFD-03 (0.1% tazarotene) Lotion

DFD-03 Lotion (0.1% tazarotene) - twice daily application

DRUG

DFD-03 (0% tazarotene) Lotion (Placebo)

DFD-03 Vehicle Lotion (0% tazarotene) - twice daily application

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Srinivas R. Sidgiddi, M.D. · Dr. Reddy's Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-06
Primary Completion
2018-05-14
Completion
2018-05-14
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 NCT03292640 on ClinicalTrials.gov