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

Introduction: Epidermlysis bullosa (EB) is a rare inherited genetic skin disorder which requires use of multiple topical or systemic medications to accelerate wound healing and reduce itch. The aim of this study was to evaluate a topical formulation of Henna 1% in the management of wound and the itching sensation in patients with EB.Materials and Methods: This is an open single arm pilot clinical trial study. Nine patients with recessive dystrophic EB (RDEB), with the age range of 5 to 32 years old were enrolled into the study. The patients and their parents were informed about the whole aspects of the study protocol and written informed consents were obtained. The formulation of Henna was prepared in school of pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran. The patients received the product in 50 gram containers. Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, any systemic diseases except EB, and positive history of hypersensitivity with henna were excluded from the study. The patients were taught to apply the drug once daily on two erosions and also on 2 sites with moderate to severe itching for 4 weeks with weekly follow-up visits. Patient global impression of improvement (PGI-I), visual analogue scale (VAS), and clinical global impression of improvement (CGI-I) were used for assessing the wound healing process and itching discomfort.Results: overall, 7 out of 9 patients completed 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 on wound healing, reduction of the wound discharge and improving re-epithelization. One of patients reported 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 the management of wound healing and itch in patients with EB. Further randomized controlled studies are recommended to better evaluate this product.