Safety and Efficacy of Local Administration of Contractubex® to Hypertrophic Scars in Comparison

Objectives: To investigate the safety and efficacy of Contractubex® administration to hypertrophic scars in routine out-patient practice and to compare it to corticosteroid treatment. Patients and Methods: This was a multicenter, retrospective cohort study, based on 38 randomly selected practices representatively distributed in Germany, including dermatologists and general practitioners. Data from 859 patients fulfilling the inclusion criteria were assessed and analyzed. Of these, 771 patients were eligible for the per protocol treatment with Contractubex® (n=555) and corticosteroid (n=216). The safety and efficacy of local administration of Contractubex® to hypertrophic scars was compared to corticosteroid treatment. Results: At the end of defined treatment periods (minimum 28 days for local therapy with 1 intralesional corticosteroid application), normalization of the pre-treatment pathological parameters (erythema, pruritus, consistency) of hypertrophic scars was more frequent (42.5%) after Contractubex® per protocol treatment as compared to corticosteroid per protocol treatment (22.2%). After adjusting imbalances of baseline characterisics between the treatment groups by the propensity score, the odds ratio was 2.274, demonstrating a significant superiority (p<0.001) of Contractubex® treatment as compared to corticosteroid treatment. The time to normalization of erythema, pruritus and consistency was significantly (p=0.034) shorter with Contractubex® treatment (median 344 days) than with corticosteroids (median 507 days). No unexpected or severe adverse events occurred in the Contractubex®-treated patients. Apart from moderate pruritus (10% Contractubex® vs. 1% corticosteroids), adverse events were significantly (p<0.001) more frequent in corticosteroid-treated patients (teleangiectasias 15% vs. 7% Contractubex®; cutaneous atrophy of scars 10% vs. 2% Contractubex®; cutaneous atrophy of scar surrounding skin tissue 11% vs. 1% Contractubex®). Conclusion: For the primary aim of this study (assessment of normalization of erythema, pruritus, and consistency of hypertrophic scars) and for time to normalization, local administration of Contractubex® was significantly more effective than corticosteroid treatment. Concerning safety, Contractubex® treatment was associated with significantly less adverse events (e.g. teleangiectasias, cutaneous atrophy of scars and surrounding skin tissue) than topical corticosteroid application. Hypertrophic scars develop as the result of a proliferation of dermal tissue following skin injury. They are confined to the original injury and increase in size by pushing outward and not by invasion (1). Pathophysiologically, hypertrophic scars are characterized by exaggerated extracellular matrix deposition resulting in increased skin tension (2-4). Clinically, they present as elevated plaques or nodules associated with erythema, pruritus and pain and can be complicated by secondary infections and contractions, which can result in cosmetic disfigurement (1, 5). The therapeutic management of hypertrophic scars is a problem that has not yet been satisfactorily solved and includes, e.g., compression therapy, topical/intralesional corticosteroid application, excision, radiation, cryotherapy, laser therapy, interferon therapy, and other therapies directed at a reduction of 277 Correspondence to: Prof. Dr. J. Beuth, Institut zur wissenschaftlichen Evaluation, naturheilkundlicher Verfahren, an der Universitaet zu Koeln, Robert-Koch-Str. 10, 50931 Koeln, Germany. Tel: 0049-221478 6414, Fax: 0049-221-478 7017, e-mail: [email protected]