A Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules

Phase 2 Completed 205 enrolled Dr. Reddy's Laboratories Limited

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2017-10-01
Primary completion: 2018-11-07
Completion: 2019-03-31

Outcome

Met primary endpoint

paper DFD-29 40mg met both co-primary endpoints, achieving IGA treatment success in 66.0 percent subjects versus 11.5 percent placebo (p<0.0001) PMID 35096250 ↗

Publications

Tsianakas A, Pieber T, Baldwin H, Feichtner F, Alikunju S, Gautam A, Shenoy S, Singh P, Sidgiddi S. Minocycline Extended-Release Comparison with Doxycycline for the Treatment of Rosacea: A Randomized, Head-to-Head, Clinical Trial. J Clin Aesthet Dermatol. 2021 Dec;14(12):16-23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Doxycycline	Small molecule	40 mg	Oral
Subject	Minocycline	Small molecule	20 mg	Oral
Subject	Minocycline	Small molecule	40 mg	Oral