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Local heat application for the treatment of Buruli ulcer : results of a phase II open label single center non comparative clinical trial

Vogel, Moritz and Bayi, Pierre F. and Ruf, Marie-Thérèse and Bratschi, Martin W. and Bolz, Miriam and Um Boock, Alphonse and Zwahlen, Marcel and Pluschke, Gerd and Junghanss, Thomas. (2016) Local heat application for the treatment of Buruli ulcer : results of a phase II open label single center non comparative clinical trial. Clinical Infectious Diseases, 62 (3). pp. 342-350.

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Abstract

Buruli ulcer (BU) is a necrotizing skin disease most prevalent among West African children. The causative organism, Mycobacterium ulcerans, is sensitive to temperatures above 37°C. We investigated the safety and efficacy of a local heat application device based on phase change material.; In a phase II open label single center noncomparative clinical trial (ISRCTN 72102977) under GCP standards in Cameroon, laboratory confirmed BU patients received up to 8 weeks of heat treatment. We assessed efficacy based on the endpoints 'absence of clinical BU specific features' or 'wound closure' within 6 months ("primary cure"), and 'absence of clinical recurrence within 24 month' ("definite cure").; Of 53 patients 51 (96%) had ulcerative disease. 62% were classified as World Health Organization category II, 19% each as category I and III. The average lesion size was 45 cm(2). Within 6 months after completion of heat treatment 92.4% (49 of 53, 95% confidence interval [CI], 81.8% to 98.0%) achieved cure of their primary lesion. At 24 months follow-up 83.7% (41 of 49, 95% CI, 70.3% to 92.7%) of patients with primary cure remained free of recurrence. Heat treatment was well tolerated; adverse effects were occasional mild local skin reactions.; Local thermotherapy is a highly effective, simple, cheap and safe treatment for M. ulcerans disease. It has in particular potential as home-based remedy for BU suspicious lesions at community level where laboratory confirmation is not available.; ISRCT 72102977.
Faculties and Departments:09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Medical Parasitology and Infection Biology > Molecular Immunology (Pluschke)
UniBasel Contributors:Ruf, Marie-Thérèse and Bratschi, Martin and Pluschke, Gerd
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Oxford University Press
ISSN:1058-4838
e-ISSN:1537-6591
Note:Publication type according to Uni Basel Research Database: Journal article
Language:English
Identification Number:
Last Modified:25 Oct 2017 10:37
Deposited On:19 Apr 2016 12:24

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