Impact of low-dose calcipotriol ointment on wound healing, pruritus and pain in patients with dystrophic epidermolysis bullosa: A randomized, double-blind, placebo-controlled trial

Abstract Background Wound management is a critical factor when treating patients with the inherited skin fragility disease dystrophic epidermolysis bullosa (DEB). Due to genetic defects in structural proteins, skin and mucous epithelia are prone to blistering and chronic wounding upon minor trauma....

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Autores principales:	Christina Guttmann-Gruber, Josefina Piñón Hofbauer, Birgit Tockner, Victoria Reichl, Alfred Klausegger, Peter Hofbauer, Martin Wolkersdorfer, Khek-Chian Tham, Seong Soo Lim, John E. Common, Anja Diem, Katharina Ude-Schoder, Wolfgang Hitzl, Florian Lagler, Julia Reichelt, Johann W. Bauer, Roland Lang, Martin Laimer
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Epidermolysis bullosa Wound healing Pruritus Vitamin D3 Calcipotriol Medicine R
Acceso en línea:	https://doaj.org/article/97b40c2da2df4214a64bb591a0e70e81
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spelling	oai:doaj.org-article:97b40c2da2df4214a64bb591a0e70e812021-11-14T12:25:09ZImpact of low-dose calcipotriol ointment on wound healing, pruritus and pain in patients with dystrophic epidermolysis bullosa: A randomized, double-blind, placebo-controlled trial10.1186/s13023-021-02062-21750-1172https://doaj.org/article/97b40c2da2df4214a64bb591a0e70e812021-11-01T00:00:00Zhttps://doi.org/10.1186/s13023-021-02062-2https://doaj.org/toc/1750-1172Abstract Background Wound management is a critical factor when treating patients with the inherited skin fragility disease dystrophic epidermolysis bullosa (DEB). Due to genetic defects in structural proteins, skin and mucous epithelia are prone to blistering and chronic wounding upon minor trauma. Furthermore, these wounds are commonly associated with excessive pruritus and predispose to the development of life-threatening squamous cell carcinomas, underscoring the unmet need for new therapeutic options to improve wound healing in this patient cohort. Vitamin D3 is acknowledged to play an important role in wound healing by modulating different cellular processes that impact epidermal homeostasis and immune responses. In this study, we evaluate the safety and efficacy of low-dose calcipotriol, a vitamin D3 analogue, in promoting wound healing and reducing itch and pain in patients with DEB. Methods Eligible DEB patients, aged ≥ 6 years and with a known mutation in the COL7A1 gene, were recruited to a placebo-controlled, randomized, double blind, cross-over phase II monocentric clinical trial. Patients were required to have at least two wounds with a minimum size of 6 cm2 per wound. The primary objective was to evaluate efficacy of daily topical application of a 0.05 µg/g calcipotriol ointment in reducing wound size within a 4-week treatment regimen. Secondary objectives were to assess safety, as well as the impact of treatment on pruritus, pain, and bacterial wound colonization in these patients. Results Six patients completed the clinical trial and were included into the final analysis. Topical low-dose calcipotriol treatment led to a significant reduction in wound area at day 14 compared to placebo (88.4% vs. 65.5%, P < 0.05). Patients also reported a significant reduction of pruritus with calcipotriol ointment compared to placebo over the entire course of the treatment as shown by itch scores of 3.16 vs 4.83 (P < 0.05) and 1.83 vs 5.52 (P < 0.0001) at days 14 and 28, respectively. Treatment with low-dose calcipotriol did not affect serum calcium levels and improved the species richness of the wound microbiome, albeit with no statistical significance. Conclusions Our results show that topical treatment with low-dose calcipotriol can accelerate wound closure and significantly reduces itch, and can be considered a safe and readily-available option to improve local wound care in DEB patients. Trial Registration EudraCT: 2016–001,967-35. Registered 28 June 2016, https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-001967-35/ATChristina Guttmann-GruberJosefina Piñón HofbauerBirgit TocknerVictoria ReichlAlfred KlauseggerPeter HofbauerMartin WolkersdorferKhek-Chian ThamSeong Soo LimJohn E. CommonAnja DiemKatharina Ude-SchoderWolfgang HitzlFlorian LaglerJulia ReicheltJohann W. BauerRoland LangMartin LaimerBMCarticleEpidermolysis bullosaWound healingPruritusVitamin D3CalcipotriolMedicineRENOrphanet Journal of Rare Diseases, Vol 16, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Epidermolysis bullosa Wound healing Pruritus Vitamin D3 Calcipotriol Medicine R
spellingShingle	Epidermolysis bullosa Wound healing Pruritus Vitamin D3 Calcipotriol Medicine R Christina Guttmann-Gruber Josefina Piñón Hofbauer Birgit Tockner Victoria Reichl Alfred Klausegger Peter Hofbauer Martin Wolkersdorfer Khek-Chian Tham Seong Soo Lim John E. Common Anja Diem Katharina Ude-Schoder Wolfgang Hitzl Florian Lagler Julia Reichelt Johann W. Bauer Roland Lang Martin Laimer Impact of low-dose calcipotriol ointment on wound healing, pruritus and pain in patients with dystrophic epidermolysis bullosa: A randomized, double-blind, placebo-controlled trial
description	Abstract Background Wound management is a critical factor when treating patients with the inherited skin fragility disease dystrophic epidermolysis bullosa (DEB). Due to genetic defects in structural proteins, skin and mucous epithelia are prone to blistering and chronic wounding upon minor trauma. Furthermore, these wounds are commonly associated with excessive pruritus and predispose to the development of life-threatening squamous cell carcinomas, underscoring the unmet need for new therapeutic options to improve wound healing in this patient cohort. Vitamin D3 is acknowledged to play an important role in wound healing by modulating different cellular processes that impact epidermal homeostasis and immune responses. In this study, we evaluate the safety and efficacy of low-dose calcipotriol, a vitamin D3 analogue, in promoting wound healing and reducing itch and pain in patients with DEB. Methods Eligible DEB patients, aged ≥ 6 years and with a known mutation in the COL7A1 gene, were recruited to a placebo-controlled, randomized, double blind, cross-over phase II monocentric clinical trial. Patients were required to have at least two wounds with a minimum size of 6 cm2 per wound. The primary objective was to evaluate efficacy of daily topical application of a 0.05 µg/g calcipotriol ointment in reducing wound size within a 4-week treatment regimen. Secondary objectives were to assess safety, as well as the impact of treatment on pruritus, pain, and bacterial wound colonization in these patients. Results Six patients completed the clinical trial and were included into the final analysis. Topical low-dose calcipotriol treatment led to a significant reduction in wound area at day 14 compared to placebo (88.4% vs. 65.5%, P < 0.05). Patients also reported a significant reduction of pruritus with calcipotriol ointment compared to placebo over the entire course of the treatment as shown by itch scores of 3.16 vs 4.83 (P < 0.05) and 1.83 vs 5.52 (P < 0.0001) at days 14 and 28, respectively. Treatment with low-dose calcipotriol did not affect serum calcium levels and improved the species richness of the wound microbiome, albeit with no statistical significance. Conclusions Our results show that topical treatment with low-dose calcipotriol can accelerate wound closure and significantly reduces itch, and can be considered a safe and readily-available option to improve local wound care in DEB patients. Trial Registration EudraCT: 2016–001,967-35. Registered 28 June 2016, https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-001967-35/AT
format	article
author	Christina Guttmann-Gruber Josefina Piñón Hofbauer Birgit Tockner Victoria Reichl Alfred Klausegger Peter Hofbauer Martin Wolkersdorfer Khek-Chian Tham Seong Soo Lim John E. Common Anja Diem Katharina Ude-Schoder Wolfgang Hitzl Florian Lagler Julia Reichelt Johann W. Bauer Roland Lang Martin Laimer
author_facet	Christina Guttmann-Gruber Josefina Piñón Hofbauer Birgit Tockner Victoria Reichl Alfred Klausegger Peter Hofbauer Martin Wolkersdorfer Khek-Chian Tham Seong Soo Lim John E. Common Anja Diem Katharina Ude-Schoder Wolfgang Hitzl Florian Lagler Julia Reichelt Johann W. Bauer Roland Lang Martin Laimer
author_sort	Christina Guttmann-Gruber
title	Impact of low-dose calcipotriol ointment on wound healing, pruritus and pain in patients with dystrophic epidermolysis bullosa: A randomized, double-blind, placebo-controlled trial
title_short	Impact of low-dose calcipotriol ointment on wound healing, pruritus and pain in patients with dystrophic epidermolysis bullosa: A randomized, double-blind, placebo-controlled trial
title_full	Impact of low-dose calcipotriol ointment on wound healing, pruritus and pain in patients with dystrophic epidermolysis bullosa: A randomized, double-blind, placebo-controlled trial
title_fullStr	Impact of low-dose calcipotriol ointment on wound healing, pruritus and pain in patients with dystrophic epidermolysis bullosa: A randomized, double-blind, placebo-controlled trial
title_full_unstemmed	Impact of low-dose calcipotriol ointment on wound healing, pruritus and pain in patients with dystrophic epidermolysis bullosa: A randomized, double-blind, placebo-controlled trial
title_sort	impact of low-dose calcipotriol ointment on wound healing, pruritus and pain in patients with dystrophic epidermolysis bullosa: a randomized, double-blind, placebo-controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/97b40c2da2df4214a64bb591a0e70e81
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Impact of low-dose calcipotriol ointment on wound healing, pruritus and pain in patients with dystrophic epidermolysis bullosa: A randomized, double-blind, placebo-controlled trial

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