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NCT03341910 · ClinicalTrials.gov registry record · Phase 2

A Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® Cream, 0.1% in the Topical Treatment of Acne Vulgaris

A Phase 2 study, sponsored by Dr. Reddy's Laboratories Limited.

Completed
Registry status
Phase 2
Development phase
155
Enrollment target

NCT03341910: Completed Phase 2 study, sponsored by Dr. Reddy's Laboratories Limited.

NCT03341910 is a Phase 2 study that has completed, run by Dr. Reddy's Laboratories Limited. The registered enrollment target is 155 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03341910, a Phase 2 study, has completed, sponsored by Dr. Reddy's Laboratories Limited.

COMPLETED
Registry status
Phase 2
Development phase
155 participants
Enrollment target

Study 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.

Primary Outcome

Frequency count of treatment emergent adverse events will be compared between DFD-03 Lotion and Tazorac Cream groups.

Interventions

  • DRUG Tazorac Cream, 0.1%
  • DRUG DFD-03 Lotion, 0.1%
  • DRUG DFD-03 Vehicle Lotion 0%
  • DRUG Tazorac Vehicle Cream 0%

Trial Details

FieldValue
Enrollment Target 155 participants
Start Date 2017-08-21
Est. Completion 2018-05-18
Phase Phase 2
Dr. Reddy's Laboratories Limited

52 total trials

What the finished NCT03341910 record still lists

NCT03341910 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher).

The record links to 0 conditions, and to 4 interventions - of which Tazorac Cream, 0.1% is the first listed.

NCT03341910 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03341910 about?

NCT03341910 is a clinical study titled "A Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® Cream, 0.1% in the Topical Treatment of Acne Vulgaris". 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. Sa...

What is the current status of trial NCT03341910?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 155 participants. The study started on 2017-08-21. Estimated completion is 2018-05-18.

What interventions are being tested in trial NCT03341910?

The interventions under investigation include: Tazorac Cream, 0.1% (DRUG), DFD-03 Lotion, 0.1% (DRUG), DFD-03 Vehicle Lotion 0% (DRUG), Tazorac Vehicle Cream 0% (DRUG).

Who is sponsoring clinical trial NCT03341910?

This trial is sponsored by Dr. Reddy's Laboratories Limited, which has 52 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03341910's enrollment target sits among peer trials

155 448th of 2000 higher than 1,553 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03341910, the US trial registry maintained by the National Library of Medicine. NCT03341910 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.