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Institute of Dermatology,Chinese Academy of Medical Sciences,Nanjing 210042, China

Objective To observe the clinical efficacy and safety of tranilast capsule in the treatment of keloid. Methods A randomized, double-blind, parallel placebo-controlled clinical study was conducted. The patients were randomly divided into two groups, test group and control group, received oral tranilast capsule or placebo capsule, 100mg thrice a day for 12 weeks. Both groups also topically applied Hirudoid cream every day. The primary endpoint was the thickness of lesions determined by ultra-sound B examination, and secondary endpoints included the hardness, pruritus, pain intensity of lesions. All patients were evaluated at baseline, 4, 8 and 12 weeks after the beginning of treatment. Side effects were recorded at every follow-up. Results One hundred and forty-three patients with keloid were enrolled into this study, and 124 patients ( 60 in the test group, and 64 in the control group) completed the trial followed the protocol. At the end of the study, the decrease rates of lesion thickness and total scores of symptom and sign, effective rate were (27.83±21.68)%, (39.42 ±19.77)% and 15.00% respectively in the test group, (15.23 ±17.02)%,(0.64 ±0.95)% and 4.69% respectively in the control group, with significant difference between the two groups (P=0.001, 0.006, 0.046, respectively). The occurrence rate of side effects were of no significant difference between the two groups(5.88% vs 2.86%, P=0.438). Conclusion The results suggest that tranilast capsule may be effective and safe in the treatment of keloid.