A prospective split-face double-blind randomized placebo-controlled trial to assess the efficacy of methyl aminolevulinate + red-light in patients with facial photodamage.

التفاصيل البيبلوغرافية
العنوان:	A prospective split-face double-blind randomized placebo-controlled trial to assess the efficacy of methyl aminolevulinate + red-light in patients with facial photodamage.
المؤلفون:	Sanclemente G; Group of Investigative Dermatology - GRID, Dermatology Section, Department of Internal Medicine, School of Medicine, University of Antioquia, Medellín, Colombia. gsanclemente@une.net.co, Medina L, Villa JF, Barrera LM, Garcia HI
المصدر:	Journal of the European Academy of Dermatology and Venereology : JEADV [J Eur Acad Dermatol Venereol] 2011 Jan; Vol. 25 (1), pp. 49-58.
نوع المنشور:	Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة:	English
بيانات الدورية:	Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 9216037 Publication Model: Print Cited Medium: Internet ISSN: 1468-3083 (Electronic) Linking ISSN: 09269959 NLM ISO Abbreviation: J Eur Acad Dermatol Venereol Subsets: MEDLINE
أسماء مطبوعة:	Publication: Oxford : Wiley-Blackwell Original Publication: Amsterdam ; New York : Elsevier Science Publishers, c1992-
مواضيع طبية MeSH:	Face* , Phototherapy/adverse effects, Aminolevulinic Acid/analogs & derivatives , Skin Aging/*drug effects, Adult ; Aminolevulinic Acid/adverse effects ; Aminolevulinic Acid/pharmacology ; Aminolevulinic Acid/therapeutic use ; Double-Blind Method ; Female ; Humans ; Middle Aged ; Placebos ; Prospective Studies ; Skin Aging/radiation effects
مستخلص:	Background: To date, there is no gold standard therapy for skin photoageing. In the last decade, laser technologies have offered great promise among skin-rejuvenation therapies; however, both non-ablative and ablative fractional resurfacing modalities have their own benefits and drawbacks. More recently, open-label studies and few controlled trials have suggested that photodynamic therapy may have therapeutic potential in photodamage. Objective: To assess the efficacy of methyl aminolevulinate + red-light on facial photodamage in a double-blind split-face randomized placebo-controlled trial. Methods: Subjects had initially two split-face treatments 2-3 weeks apart in which half of the face was treated with MAL + red-light compared with placebo + red-light. Primary outcome was the assessment of global photodamage 1 month after session 2. Secondary outcomes included the assessment of fine lines, mottled pigmentation, tactile roughness, sallowness, erythema and telangiectasia 1 month after session 2, according to severity scores rated as failure, improvement or success. Results: Based on the intention-to-treat analysis, a total of 48 patients (96 split-faces) were included. Facial global photodamage success or improvement had occurred in 94 split-faces and in no split-faces receiving placebo (RR: 0.02; 95% confidence interval, 0.0-0.14; P = 0.0000). One patient had an adverse event that led to the discontinuation of the therapy after session 1. Conclusions: Methyl aminolevulinate + red-light demonstrated significantly superior efficacy in global facial photodamage compared with placebo. This therapy was also useful for all other specific secondary outcomes, except for telangiectasia. Overall, MAL + red-light sessions were well tolerated and resulted in high/total patient satisfaction in the majority of subjects (80.4%). (© 2010 The Authors. Journal of the European Academy of Dermatology and Venereology © 2010 European Academy of Dermatology and Venereology.)
المشرفين على المادة:	0 (Placebos) 585NM85KYM (methyl 5-aminolevulinate) 88755TAZ87 (Aminolevulinic Acid)
تواريخ الأحداث:	Date Created: 20100512 Date Completed: 20110405 Latest Revision: 20161125
رمز التحديث:	20240628
DOI:	10.1111/j.1468-3083.2010.03687.x
PMID:	20456545
قاعدة البيانات:	MEDLINE

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تدمد:	1468-3083
DOI:	10.1111/j.1468-3083.2010.03687.x