A pilot study on the efficacy of topical formulation of Henna 1% (Lawsonia inermis) in management of wound healing and itching sensation in patients with Epidermolysis Bullosa: an open clinical trial

Introduction: Epidermlysis bullosa (EB) is a rare inherited genetic skin disorder which requires using medications for management wound healing and reduce itching sensation. The aim of this study was to evaluate topical formulation of Henna 1% in management of wound healing and itching discomfort in patient with EB.Material and Methods: This is an open single arm pilot clinical trial study. Nine patients with recessive dystrophic EB (RDEB), in age 5 to 32 years old were enrolled to the study. The patients and their parents were awarded about the whole aspects of protocol of the study and informed written consent were obtained. The formulation of Henna was prepared in school of pharmacy of Shiraz University of Medical Sciences. The patients received the product in 50 grams containers. Patients with glucose-6-phosphate dehydrogenase (G6PD), any systemic disease except EB, and positive history of hypersensitivity with henna were excluded from the study. The patients were administered to use 1 time daily at 2 open erosion site an also in 2 site with moderate to severe itching discomfort for 4 weeks with weekly follow-up. Patient global impression of improvement (PGI-I), visual analogue scale (VAS), and clinical global impression of improvement (CGI-I) for assessment the wound healing process and itching discomfort.Results: overall, 7 out of 9 patients complete the study. The average drug satisfaction rate was reported 74% by the patients. Six patients reported very much better and one reported much better in itching discomfort after using Henna product. In addition this product had a very good effect in wound healing, reduction the discharge and re-epithelization. One patients reported a moderate dryness of skin after continuous consumption for 4 weeks.Conclusion: it seems that topical formulation of Henna 1% is an acceptable herbal product for management wound healing and itching discomfort in patient with EB. Therefore, further randomized controlled studies are recommended for more evaluations of this product.

کلیدواژه ها:

Epidermlysis bullosa ، Lawsonia inermis ، wound healing ، itching