CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 155 enrolled
Drug / intervention
DFD-03 Lotion, 0.1% +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03341910
NCT03341910Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Active-Controlled Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® (Tazarotene) Cream, 0.1% in the Topical Treatment of Acne Vulgaris for 12 Weeks

Dr. Reddy's Laboratories Limited·interventional·Posted Nov 14, 2017·Updated Aug 17, 2020

In Brief

A Phase 2 clinical trial evaluating DFD-03 Lotion, 0.1%, Tazorac Cream, 0.1%, and 2 other interventions for Acne Vulgaris. Completed, enrolled 155 participants across 1 site.

Detailed Summary

A study for Subjects with mild to moderate facial acne vulgaris. During the 12-week treatment period subjects randomized to DFD-03 Lotion or Vehicle Lotion will use the study drug twice daily. Subjects randomized to Tazorac Cream or Vehicle Cream will use the study drug once daily in the evening. Safety assessments will include the investigator's assessment of local cutaneous tolerance/application site reactions on the face, vital signs and adverse events.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 14, 2017
Enrollment StartAug 21, 2017
Primary CompletionMay 18, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.6 years ago

Interventions

DFD-03 Lotion, 0.1%drug

DFD-03 Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.

Tazorac Cream, 0.1%drug

Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.

DFD-03 Vehicle Lotion 0%drug

Vehicle Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.

Tazorac Vehicle Cream 0%drug

Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.