Efficacy and safety of oral DFD-29 versus doxycycline in rosacea: A systematic review and meta-analysis

Clin Exp Dermatol. 2026 Mar 9:llag118. doi: 10.1093/ced/llag118. Online ahead of print.

ABSTRACT

BACKGROUND: Rosacea is a chronic skin disorder causing facial erythema, telangiectasias, papules, and pustules. Guidelines recommend sub-antimicrobial doses, such as doxycycline 40 mg. If symptoms persist, evaluating the efficacy and safety of sub-antimicrobial minocycline may expand therapeutic options.

AIM: The present systematic review and meta-analysis evaluates DFD-29 as a low-dose tetracycline alternative to treat rosacea.

METHODS: Our analysis included data from three RCTs sourced from PubMed, Embase, and Cochrane databases to compare the Investigator’s Global Assessment (IGA) success, reduction in inflammatory lesion counts, treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs) in patients using DFD-29 versus modified-release doxycycline. Statistical analyses were conducted using RStudio.

RESULTS: In pooled analysis of 643 patients, DFD-29 significantly increased the likelihood of achieving a successful IGA score compared to doxycycline (OR 2.51; 95% CI 1.80 to 3.49; p < 0.001; I2 = 0%). The DFD-29 40 mg group had significantly greater reductions in IGA scores compared to the 20 mg group (p = 0.0210). The DFD-29 40 mg group also exhibited a higher reduction in inflammatory lesion counts than doxycycline (MD -4.56; 95% CI -6.18 to -2.93; p < 0.001), whereas the 20 mg group did not show significant results. There were no significant differences in TEAEs across groups (OR 0.96; 95% CI 0.55 to 1.66; p = 0.87; I2 = 0%), with only one SEA (atrial fibrillation) was reported with DFD-29.

CONCLUSION: Our meta-analysis showed that DFD-29 at 40 mg daily, is a superior and well-tolerated alternative to modified-release doxycycline for moderate-to-severe rosacea.

PMID:41802266 | DOI:10.1093/ced/llag118