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Effectiveness and Safety of an Overnight Patch Containing Allium cepa Extract and Allantoin for Post-Dermatologic Surgery Scars

BACKGROUND: An occlusive overnight intensive patch medical device (OIP) containing onion extract and allantoin has been developed for preventing and treating dermatologic scars and keloids. Here, we examined the efficacy and safety of the OIP for post-dermatologic surgery scars. METHODS: This was an...

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Autores principales: Prager, Welf, Gauglitz, Gerd G.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6097777/
https://www.ncbi.nlm.nih.gov/pubmed/29948103
http://dx.doi.org/10.1007/s00266-018-1172-4
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author Prager, Welf
Gauglitz, Gerd G.
author_facet Prager, Welf
Gauglitz, Gerd G.
author_sort Prager, Welf
collection PubMed
description BACKGROUND: An occlusive overnight intensive patch medical device (OIP) containing onion extract and allantoin has been developed for preventing and treating dermatologic scars and keloids. Here, we examined the efficacy and safety of the OIP for post-dermatologic surgery scars. METHODS: This was an intra-individual randomized, observer-blind, controlled study in adults with post-dermatologic surgery scars. Two scars per subject were randomized to no treatment or overnight treatment with the OIP for 12–24 weeks. Scar quality was assessed using the Patient and Observer Scar Assessment Scale (POSAS) and a Global Aesthetic Improvement Scale. RESULTS: A total of 125 subjects were included. The decrease in observer-assessed POSAS from baseline was significantly greater for treated than untreated scars at week 6 (p < 0.001) and 24 (p = 0.001). The decrease in patient-assessed POSAS was significantly greater for the treated scar than the untreated scar at week 12 (p = 0.017) and 24 (p = 0.014). Subject- and investigator-evaluated Global Aesthetic Improvement Scale scores were higher for the treated than the untreated scar at all visits. All subjects considered the global comfort of the OIP to be good or very good, and no safety concerns were identified. CONCLUSIONS: This study confirmed that the OIP safely promotes scar healing after minor dermatologic surgery. LEVEL OF EVIDENCE II: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.
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spelling pubmed-60977772018-08-24 Effectiveness and Safety of an Overnight Patch Containing Allium cepa Extract and Allantoin for Post-Dermatologic Surgery Scars Prager, Welf Gauglitz, Gerd G. Aesthetic Plast Surg Original Article BACKGROUND: An occlusive overnight intensive patch medical device (OIP) containing onion extract and allantoin has been developed for preventing and treating dermatologic scars and keloids. Here, we examined the efficacy and safety of the OIP for post-dermatologic surgery scars. METHODS: This was an intra-individual randomized, observer-blind, controlled study in adults with post-dermatologic surgery scars. Two scars per subject were randomized to no treatment or overnight treatment with the OIP for 12–24 weeks. Scar quality was assessed using the Patient and Observer Scar Assessment Scale (POSAS) and a Global Aesthetic Improvement Scale. RESULTS: A total of 125 subjects were included. The decrease in observer-assessed POSAS from baseline was significantly greater for treated than untreated scars at week 6 (p < 0.001) and 24 (p = 0.001). The decrease in patient-assessed POSAS was significantly greater for the treated scar than the untreated scar at week 12 (p = 0.017) and 24 (p = 0.014). Subject- and investigator-evaluated Global Aesthetic Improvement Scale scores were higher for the treated than the untreated scar at all visits. All subjects considered the global comfort of the OIP to be good or very good, and no safety concerns were identified. CONCLUSIONS: This study confirmed that the OIP safely promotes scar healing after minor dermatologic surgery. LEVEL OF EVIDENCE II: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266. Springer US 2018-06-14 2018 /pmc/articles/PMC6097777/ /pubmed/29948103 http://dx.doi.org/10.1007/s00266-018-1172-4 Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Article
Prager, Welf
Gauglitz, Gerd G.
Effectiveness and Safety of an Overnight Patch Containing Allium cepa Extract and Allantoin for Post-Dermatologic Surgery Scars
title Effectiveness and Safety of an Overnight Patch Containing Allium cepa Extract and Allantoin for Post-Dermatologic Surgery Scars
title_full Effectiveness and Safety of an Overnight Patch Containing Allium cepa Extract and Allantoin for Post-Dermatologic Surgery Scars
title_fullStr Effectiveness and Safety of an Overnight Patch Containing Allium cepa Extract and Allantoin for Post-Dermatologic Surgery Scars
title_full_unstemmed Effectiveness and Safety of an Overnight Patch Containing Allium cepa Extract and Allantoin for Post-Dermatologic Surgery Scars
title_short Effectiveness and Safety of an Overnight Patch Containing Allium cepa Extract and Allantoin for Post-Dermatologic Surgery Scars
title_sort effectiveness and safety of an overnight patch containing allium cepa extract and allantoin for post-dermatologic surgery scars
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6097777/
https://www.ncbi.nlm.nih.gov/pubmed/29948103
http://dx.doi.org/10.1007/s00266-018-1172-4
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