DFD-29 Outperforms Doxycycline in Phase 3 Rosacea Trials

DFD-29 (Emrosi) may offer a new oral standard for papulopustular rosacea with superior efficacy compared to doxycycline (Oracea), according to data presented at the 2025 Fall Clinical Dermatology Conference. Findings may be particularly relevant for patients with persistent inflammatory lesions or inadequate response to current systemic therapies.1

Rosacea affects 16 million Americans, and up to 415 million people globally, and is most frequently seen in adults aged 30 to 50 years. The National Rosacea Society reported that 90% of patients surveyed said their condition had lowered their self-esteem and confidence, and many have avoided social interaction due to their symptoms. Approximately half (51%) of patients have missed work because of their rosacea and 88% said their condition adversely affected professional interactions.2

Journey Medical Corporation presented pooled results from two identically designed, pivotal Phase 3 studies (Minocycline Versus Oracea in Rosacea-1 [MVOR-1] and Minocycline Versus Oracea in Rosacea-2 [MVOR-2]) evaluating DFD-29 (minocycline HCl modified-release capsules, 40 mg total dose: 10 mg immediate release + 30 mg extended release) for the treatment of inflammatory lesions of papulopustular rosacea in adults.

The pooled analysis demonstrates statistically and clinically significant improvements with DFD-29 versus both doxycycline 40 mg and placebo, across all primary and secondary efficacy endpoints.

“These combined Phase 3 results, demonstrating Emrosi’s statistical superiority over both Oracea and placebo in achieving Investigator’s Global Assessment (IGA) treatment success and reducing total inflammatory lesion count, reaffirm the strong efficacy and safety profile that have established Emrosi as an important treatment option for patients with rosacea,” said Claude Maraoui, co-founder, president, and CEO of Journey Medical Corporation.1

The analysis focused on two multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled trials.Investigators recruited 653 adults with moderate-to-severe papulopustular rosacea, randomized 3:3:2 to receive DFD-29 (40 mg once daily), doxycycline (40 mg once daily), or placebo for 16 weeks. The primary objective was to evaluate efficacy and safety of DFD-29 vs placebo, while the secondary outcome was to compare DFD-29 with Oracea.

Patients treated with DFD-29 achieved a ~1.6-fold higher IGA success rate than Oracea (62.7% versus 39.0%, respectively; P < .001) and >2-fold higher than placebo (28.2%; P < .001). Patients in the DFD-29 cohort demonstrated a mean reduction of nearly 20 inflammatory lesions (19.2), significantly greater than either comparator (14.8 and 11.3, respectively).

Both co-primary (IGA success) and secondary (lesion reduction) endpoints were met in each trial independently and in pooled analyses.

No major safety issues or serious adverse events attributed to DFD-29. The incidence and severity of treatment-emergent adverse events (TEAEs) were comparable across all groups and no new safety signals emerged, which was consistent with the safety profile of oral tetracyclines in dermatology.

DFD-29’s dual-release (10 mg IR + 30 mg ER) formulation is designed to optimize pharmacokinetics for both early and sustained anti-inflammatory activity, potentially reducing microbial resistance risks associated with traditional antibiotic dosing.

These data support DFD-29 as a next-generation oral therapy for moderate-to-severe rosacea, offering stronger lesion reduction, higher IGA clearance rates, excellent tolerability, and potential once-daily convenience with improved consistency in clinical response.

DFD-29 is U.S. Food and Drug Administration (FDA)-approved and available inthe United States for the treatment of inflammatory lesions of rosacea in adults. Investigators noted that further post-marketing data will be important to assess long-term durability, resistance patterns, and real-world adherence.

“As we expand Emrosi’s reach and adoption, these data strengthen our position in the growing dermatology market and underscore our commitment to delivering clinically proven therapies that improve patient outcomes,” said Maraoui. “We believe Emrosi has the potential to become the standard of care for rosacea.”1

References

1. Journey Medical Corporation. Journey Medical Corporation Reports combined emrosiTM (DFD-29) phase 3 clinical trial efficacy data analysis presented at the 2025 fall clinical dermatology conference. GlobeNewswire News Room. October 24, 2025. Accessed October 25, 2025. https://www.globenewswire.com/news-release/2025/10/24/3172789/0/en/Journey-Medical-Corporation-Reports-Combined-Emrosi-DFD-29-Phase-3-Clinical-Trial-Efficacy-Data-Analysis-Presented-at-the-2025-Fall-Clinical-Dermatology-Conference.html.
2. National Rosacea Society. Rosacea.org - National Rosacea Society. Accessed October 25, 2025. https://www.rosacea.org/.