Doxepin cream is not effective in reducing itch in burn scar patients: A multicenter triple-blind randomized clinical crossover trial |
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| Institution: | 1. Division of Surgery & Interventional Science, University College London, United Kingdom;2. Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, United Kingdom;3. Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore;4. Institute of Medical Biology, A*Star, Immunos, Biomedical Grove, Singapore;5. Faculty of Health and Medical Sciences, University of Western Australia;1. Departments of Plastic and Reconstructive Surgery, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, Tel Aviv 6423906, Israel;2. Division of Dermatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel;1. Burns Service of Western Australia, WA Department of Health, Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, Western Australia 6150;2. Burn Injury Research Unit, School of Biomedical Sciences, University of Western Australia, Crawley, Western Australia 6009;3. School of Postgraduate Studies, Royal College of Surgeons in Ireland, 123 St Stephen’s Green, Dublin, Ireland D02 YN77 |
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| Abstract: | ObjectiveTo evaluate the effect of doxepin hydrochloride 5% cream on reducing pruritus in burn scar patients compared to a placebo cream.MethodWe conducted a multicenter triple-blind randomized clinical placebo-controlled crossover trial in which burn patients ≥18 years with an itch intensity ≥3 on a Visual Analogue Scale (VAS) were randomized between a doxepin-placebo or placebo-doxepin treatment protocol. Patients used each cream during two weeks with a wash-out period of one week in between. Primary outcome was change in itch intensity in two weeks’ time using the VAS. Secondary outcome included the impact of itch (Burn Itch Questionnaire). Other parameters were the use of hydrating cream, silicon treatment, pressure garments, and other antipruritic medication.ResultsTwenty-seven patients were included. The change in itch intensity (VAS) was not different during the doxepin and placebo period (p = 0.994); neither the doxepin cream nor placebo cream reduced itch intensity. However, based on the Burn Itch Questionnaire, we observed a statistically significant decrease in itch intensity and improvement in impact scores in both treatment groups, but no difference in the degree of reduction between the groups.ConclusionDoxepin cream was not effective in reducing pruritus in our burn patient study population. |
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| Keywords: | Itch Pruritus burn* Doxepin Antihistamines |
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