CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 323 enrolled
Drug / intervention
DFD-29 +2 moredrug
Likely dose
DFD-29 40 mg extended release capsulesAI-extracted
Key inclusion· 5
  • ✓Age 18 years or older
  • ✓Good general health as determined by investigator
  • ✓Clinical diagnosis of papulopustular rosacea with IGA grade 3 (moderate) or IGA grade 4 (severe) at Baseline
  • ✓15 to 60 inflammatory lesions (papules and pustules) on face at Baseline
Key exclusion· 6
  • ✕Pregnant, nursing, or planning pregnancy
  • ✕Male whose female partner is planning to conceive
  • ✕Clinically significant abnormal laboratory results that compromise safety or study participation
  • ✕History of organ transplant requiring immunosuppression, HIV, or immune compromised state

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

Search/NCT05296629
NCT05296629Phase 3Completed
CompareCT.gov

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

Journey Medical Corporation·interventional·Posted Mar 25, 2022·Updated Dec 3, 2024

In Brief

A Phase 3 clinical trial evaluating DFD-29, Doxycycline, and 1 other intervention for Papulopustular Rosacea. Completed, enrolled 323 participants across 27 sites.

Detailed Summary

This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPapulopustular Rosacea
CountriesUnited States
CollaboratorsDr. Reddy's Laboratories Limited

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMar 25, 2022
Enrollment StartMar 14, 2022
Primary CompletionJun 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.3 years ago

Interventions

DFD-29drug

DFD-29 (40 mg) extended release capsules

Doxycyclinedrug

Doxycycline 40 mg capsules

Placebodrug

Placebo capsules