A Clinical Evaluation of Safety and Efficacy of Tranilast for Keloid and Hypertrophic Scars: A Prospective, One-group, Open-labeled Study.
- Author:
Won Jai LEE
1
;
Dae Hyun LEW
;
Seum CHUNG
;
Dong Kyun RAH
;
Beyoung Yun PARK
Author Information
1. Institute for Human Tissue Restoration, Korea.
- Publication Type:In Vitro ; Original Article
- Keywords:
Tranilast;
Keloid;
Hypertrophic scar
- MeSH:
Chemistry;
Cicatrix;
Cicatrix, Hypertrophic*;
Collagen Type I;
Erythema;
Fibroblasts;
Follow-Up Studies;
Humans;
Keloid*;
Prospective Studies*;
Pruritus;
Research Personnel;
Sensation;
Superoxides;
Transforming Growth Factor beta1;
Visual Analog Scale
- From:Journal of the Korean Society of Plastic and Reconstructive Surgeons
2002;29(3):162-168
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
Keloid and hypertrophic scar are often left untreated because of no effective treatment. However, it may cause severe pain to the patient with its displeasing appearance and unbearable itching sensation and pain that occasionally accompany. Local injection of steroid has been widely accepted as a relatively effective medical treatment modality but it holds several limitations such as a severe injection pain and restricted use in sites which is either difficult to inject or too broad. Also regarding the safety, the steroid injection cannot be used to treat the scar for a long period of time or at short intervals because of the well known adverse effects of steroid. Tranilast has several in vitro pharmacological actions such as suppression of the stimulation of fibroblast by TGF-beta1, suppression of the production of superoxides and suppression of overproduction of collagen type I and III by fibroblast and these properties have made Tranilast to be considered as an alternate treatment modality. Authors studied 35 patients with keloid and hypertrophic scar to evaluate the effectiveness and safety of Tranilast. For evaluation of efficacy, the itching sensation and pain (self-conscious symptoms) was measured with Visual Analog Scale (VAS: 10-point scare) and the severity of the symptom was scored. The erythema (nonself-conscious symptom) was evaluated with subjective determination of the investigators and the degree of improvement was measured with software program using the L*a*b* color coordinate system to quantify the effect of treatment. For evaluation of safety, laboratory tests (hematology, blood chemistry, urinalysis) and existence of adverse effects was examined. This prospective study examined 35 patients who could go through the follow-up examination for 12 weeks and the results are as follow. First, scores higher than good were achieved in 80% (28/5) of the patient 6 weeks after the first administration and in 71.4% (25/35) in 12 weeks after administration of Tranilast. Second, global improvement of symptoms was approximated to be 5.6 points in itching sensation, pain and redness. Each was 51%, 56%, and 33% respectively, and this shows that Tranilast is effective in non-self conscious symptoms as well as self-conscious symptoms. Third, the subjective evaluation of improvement of erythema by software program using the L*a*b* color coordinate system showed mean improvement of 43%. There was no specific adverse effect and the lab tests revealed no significant change by medication.
