Efficacy and safety of tranilast combined with minocycline in the treatment of moderate-to-severe rosacea: a prospective, randomized controlled study

Background: Rosacea is a common chronic inflammatory skin disease. Mast cells are implicated in the pathogenesis of rosacea. However, the therapeutic potential of tranilast, a mast cell membrane stabilizer, remains unexplored. This study aims to evaluate the efficacy and safety of tranilast monotherapy and in combination with minocycline in patients with moderate-to-severe rosacea. Methods: This study has been registered on ClinicalTrials.gov (Registration No. NCT06307223). All enrolled patients with rosacea were randomly assigned to receive tranilast, minocycline, or a combination of both. Tranilast (0.1 g, three times daily) and minocycline (50 mg, once daily) were administered for 12 weeks, with follow-up every two weeks. Results: Forty-five patients completed the study. At week 12, the combination group showed a significantly higher IGA success rate (93.33%) compared to the tranilast (53.33%) and minocycline (46.67%) groups (p < 0.05). The secondary endpoints, such as CEA success rate, erythema index, and erythema score, also favored the combination group over minocycline group (p = 0.021, 0.030, and 0.024, respectively). Conclusion: In our study, patients with moderate to severe rosacea treated with tranilast showed a favorable clinical response and experienced no serious adverse events. The combination therapy yielded better outcomes than minocycline monotherapy, especially in improving facial erythema.