CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 205 enrolled
Drug / intervention
DFD-29 Extended Release Capsules (40 mg) +3 moredrug
Likely dose
DFD-29 Extended Release Capsules (40 mg)from 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/NCT03340961
NCT03340961Phase 2Completed
CompareCT.gov

A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea Over 16 Weeks

Dr. Reddy's Laboratories Limited·interventional·Posted Nov 14, 2017·Updated Mar 1, 2021

In Brief

A Phase 2 clinical trial evaluating DFD-29 Extended Release Capsules (40 mg), DFD-29 Extended Release Capsules (20 mg), and 2 other interventions for Rosacea. Completed, enrolled 205 participants across 14 sites.

Detailed Summary

Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment (IGA, modified scale without erythema), Clinician's Erythema Assessment (CEA), and on inflammatory lesion counts at Weeks 4, 8, 12 and 16 in comparison to Baseline.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRosacea
CountriesGermany
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 14, 2017
Enrollment StartOct 1, 2017
Primary CompletionNov 7, 2018
Study CompletionMar 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.6 years ago

Interventions

DFD-29 Extended Release Capsules (40 mg)drug

Oral Treatment

DFD-29 Extended Release Capsules (20 mg)drug

Oral Treatment

Oraycea® (doxycycline) Capsulesdrug

Oral Treatment

Placebo Capsulesdrug

Oral Treatment