Objective: Subantibiotic dose doxycycline (SDD40), formulated as a modified-release 40mg capsule administered once daily, is used to treat inflammatory lesions of rosacea. In order to investigate whether the patient's weight or lesion severity impacts clinical outcomes with using SDD40, the efficacy and safety of SDD40 in treating rosacea were evaluated in randomized controlled studies (RCTs).
Methods: Phase II, III, and IV RCTs, and a subsequent meta-analysis were described. For all studies, the primary efficacy endpoint was the change in total inflammatory lesion count (papules, pustules, and nodules) from baseline to Week 16. For one of the studies, body weights were categorized by BMI (body mass index). Secondary efficacy endpoints included the change in Investigator's Global Assessment (IGA). Safety was assessed by monitoring adverse events (AEs).
Results: The efficacy of SDD40 was consistent across the studies (two trials including n=72 and n=91 subjects) and meta-analysis (n=127 and n=142). SDD40 remained effective regardless of baseline disease severity and weight (with a weak correlation coefficient below 0.75); overweight or obese subjects with severe rosacea cleared at least as well if not better than those with a normal BMI and mild disease. The treatment was well tolerated with no to minimal gastrointestinal-related AEs.
Limitations: Retrospective analyses have methodological limitations.
Conclusion: Consistency between study results including the meta-analysis supports the effectiveness and safety of SDD40, irrespective of the weight of the patient or rosacea severity based on inflammatory lesion count at baseline.
Keywords: antimicrobial resistance; body mass index (BMI); inflammatory lesions of rosacea; obesity; subantibiotic dose oral doxycycline (SDD40); subantimicrobial-dose oral doxycycline.
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