Efficacy and Safety of Different Dose Regimens of Gabapentin for Treating Erythema/Flushing in Rosacea: A Randomized Controlled Trial

Summary

The goal of this clinical trial is to learn if Gabapentin works to treat flushing/erythema associated with rosacea. It will also learn about the safety of drug Gabapentin. The main questions it aims to answer are: * Does drug Gabapentin reduce flushing and erythema associated with rosacea? * What medical problems do participants have when taking drug Gabapentin? Researchers will compare Gabapentin to a positive control (minocycline plus hydroxychloroquine, a first-line treatment for rosacea) to see if drug Gabapentin works to reduce flushing and erythema associated with rosacea

Timeline

Start

2024-01-05

Primary completion

2025-07-31

Completion

2025-07-31

Publications

• Results Del Rosso JQ, Webster G, Weiss JS, Bhatia ND, Gold LS, Kircik L. Nonantibiotic Properties of Tetracyclines in Rosacea and Their Clinical Implications. J Clin Aesthet Dermatol. 2021 Aug;14(8):14-21. Epub 2021 Aug 1.
• Results Ma G, Zhang Y, Gao Q, Yuan X, Zhou Z, Jian D, Zhao Z, Wang B, Li J. Gabapentin improves the flushing of rosacea, but not other rosacea symptoms or quality of life: Results from a multicenter, randomized, double-blind, placebo-controlled pilot study. J Am Acad Dermatol. 2025 Apr;92(4):920-922. doi: 10.1016/j.jaad.2024.12.003. Epub 2024 Dec 15. No abstract available.
• Results Wei J, Wan M, Chen Q, Fu J, Yang L, Ni R, Ge L, Dan Y, Chen X, Kong M, Li L, Chen S, Yang S, Zhang L, Xia A, Tang L, Zhang Y, Zhang M, Song Z, Li J. Gabapentin is an efficacy treatment for facial flushing and erythema of erythematotelangiectatic rosacea: A randomized clinical noninferiority trial. J Am Acad Dermatol. 2025 Apr;92(4):927-930. doi: 10.1016/j.jaad.2024.12.011. Epub 2024 Dec 20. No abstract available.
• Results Logger JGM, Olydam JI, Driessen RJB. Use of beta-blockers for rosacea-associated facial erythema and flushing: A systematic review and update on proposed mode of action. J Am Acad Dermatol. 2020 Oct;83(4):1088-1097. doi: 10.1016/j.jaad.2020.04.129. Epub 2020 Apr 29.
• Results Husein-ElAhmed H, Steinhoff M. Evaluation of the efficacy of subantimicrobial dose doxycycline in rosacea: a systematic review of clinical trials and meta-analysis. J Dtsch Dermatol Ges. 2021 Jan;19(1):7-17. doi: 10.1111/ddg.14247. Epub 2020 Sep 28.
• Results Clanner-Engelshofen BM, Bernhard D, Dargatz S, Flaig MJ, Gieler U, Kinberger M, Klovekorn W, Kuna AC, Lauchli S, Lehmann P, Nast A, Pleyer U, Schaller M, Schofer H, Steinhoff M, Schwennesen T, Werner RN, Zierhut M, Reinholz M. S2k guideline: Rosacea. J Dtsch Dermatol Ges. 2022 Aug;20(8):1147-1165. doi: 10.1111/ddg.14849. Epub 2022 Aug 5.
• Results Tu KY, Jung CJ, Shih YH, Chang ALS. Therapeutic strategies focusing on immune dysregulation and neuroinflammation in rosacea. Front Immunol. 2024 Jul 29;15:1403798. doi: 10.3389/fimmu.2024.1403798. eCollection 2024.
• Results Barakji YA, Ronnstad ATM, Christensen MO, Zachariae C, Wienholtz NKF, Halling AS, Maul JT, Thomsen SF, Egeberg A, Thyssen JP. Assessment of Frequency of Rosacea Subtypes in Patients With Rosacea: A Systematic Review and Meta-analysis. JAMA Dermatol. 2022 Jun 1;158(6):617-625. doi: 10.1001/jamadermatol.2022.0526.

Drugs

Indications