Clinical Trials Logo

Clinical Trial 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. Of the 320 subjects, approximately 160 subjects are planned to be enrolled at 15 sites in the US, while the remaining subjects are to be enrolled at 14 sites in the EU.


Clinical Trial Description

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. Subject visits are scheduled at Screening, Baseline (Day 1), and Weeks 2, 4, 8, 12, and 16. Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment modified scale without erythema (IGA), Clinician's Erythema Assessment (CEA), and total inflammatory lesion count at Weeks 2, 4, 8, 12, and 16 compared to Baseline. Laboratory assessments of blood (hematology and biochemistry) and urine (routine tests) will be conducted at Screening and Week 16 (end of study [EOS] or early termination) to assess for any changes in the safety parameters. Other safety assessments include vital signs, physical examination, urine pregnancy tests (for females of childbearing potential), and collection of AE data. The impact of the treatment on the quality of life (QoL) of the subjects will be assessed using the rosacea-specific tool RosaQoL in addition to the Dermatology Life Quality Index (DLQI) at Baseline and Weeks 2, 4, 8, 12, and 16. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05343455
Study type Interventional
Source Journey Medical Corporation
Contact
Status Completed
Phase Phase 3
Start date March 29, 2022
Completion date June 30, 2023

See also
  Status Clinical Trial Phase
Completed NCT03276936 - A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea Phase 3
Completed NCT02601963 - Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea Phase 2
Completed NCT02268474 - Excel V 532 nm KTP Laser for Treatment of Erythematotelangiectatic Rosacea & Papulopustular Rosacea N/A
Completed NCT01555463 - Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea Phase 3
Active, not recruiting NCT03667222 - Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea Phase 2
Terminated NCT03564145 - A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea Phase 3
Completed NCT05150587 - Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea Phase 2
Completed NCT03263273 - Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea Phase 2
Completed NCT01784133 - A Twelve Week Safety and Efficacy Study in Rosacea Phase 2
Completed NCT01872715 - Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea Phase 4
Completed NCT05296629 - A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea. Phase 3
Completed NCT05838170 - Study of TP-04 in Participants With Papulopustular Rosacea Phase 2
Recruiting NCT06013371 - PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea Phase 2
Recruiting NCT03864978 - Safety and Efficacy of Rifaximin in Patients With Papulopustular Rosacea and Positive Lactulose Breath Test Phase 2
Completed NCT03564119 - A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea Phase 3
Completed NCT03079531 - Open Label Study to Assess the Effect of Secukinumab in Moderate to Severe Papulopustular Rosacea Phase 1/Phase 2
Completed NCT01045551 - Open Label Pilot Study of Apremilast in Treatment of Rosacea Phase 2
Completed NCT03448939 - A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea Phase 3
Completed NCT05675501 - Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties Phase 1
Withdrawn NCT03883945 - A Safety and Efficacy Study to Evaluate Rosacea Phase 1/Phase 2