Impact of Oral DFD-29, a Low-Dose Formulation of Minocycline, on Quality of Life in Patients with Rosacea: Results of Two Phase 3 Randomized Controlled Trials
Recommended Citation
Gold LS, Yamauchi P, Dirschka T, Tsianakas A, Dhawan S, and Sidgiddi S. Impact of Oral DFD-29, a Low-Dose Formulation of Minocycline, on Quality of Life in Patients with Rosacea: Results of Two Phase 3 Randomized Controlled Trials. J Clin Aesthet Dermatol 2025;18(10):66-72.
Document Type
Article
Publication Date
10-1-2025
Publication Title
J Clin Aesthet Dermatol
Keywords
DFD-29; Dermatology Life Quality Index (DLQI); Rosacea; Rosacea-Specific Quality of Life (RosaQoL) questionnaire; doxycycline; minocycline; patient-reported outcomes; quality of life
Abstract
OBJECTIVE: DFD-29 is a low-dose modified formulation of minocycline 40mg that has demonstrated efficacy and safety in patients with rosacea. We report the effect of DFD-29 on patient-reported assessments of disease severity and quality of life (QoL) from two clinical trials in patients with moderate-to-severe rosacea.
METHODS: MVOR-1 (NCT05296629) and MVOR-2 (NCT05343455) were 16-week, randomized, double-blind, active- and placebo-controlled Phase III trials that compared the impact of oral DFD-29 (EMROSI, Journey Medical Corporation), doxycycline 40mg, and placebo in adults aged 18 years or older with moderate-to-severe rosacea. Changes in QoL were exploratory endpoints that were evaluated at baseline and Weeks 2, 4, 8, 12, and 16 using the Rosacea-Specific Quality of Life (RosaQoL) questionnaire and the Dermatology Life Quality Index (DLQI).
RESULTS: Among randomized subjects, 288 completed MVOR-1 (DFD-29, n=117; doxycycline, n=98; placebo, n=73) and 296 completed MVOR-2 (DFD-29, n=115; doxycycline, n=113; placebo, n=68). In both trials, DFD-29 significantly improved QoL versus placebo (p< 0.05) as assessed by RosaQoL and DLQI over 16 weeks. In MVOR-2, DFD-29 was also significantly superior to doxycycline in improving least squares mean RosaQoL scores at Week 12 (p=0.034). In MVOR-1, patients reported superior improvements in DLQI scores with DFD-29 versus doxycycline (p< 0.05) at Weeks 4, 8, and 12.
LIMITATIONS: RosaQoL and DLQI were exploratory endpoints.
CONCLUSION: These data suggest that DFD-29 may be useful in improving QoL in patients with moderate-to-severe rosacea.
PubMed ID
41416027
Volume
18
Issue
10
First Page
66
Last Page
72
