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A prospective split‐face double‐blind randomized placebo‐controlled trial to assess the efficacy of methyl aminolevulinate + red‐light in patients with facial photodamage
Author(s) -
Sanclemente G,
Medina L,
Villa JF,
Barrera LM,
Garcia HI
Publication year - 2011
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/j.1468-3083.2010.03687.x
Subject(s) - medicine , intense pulsed light , telangiectasia , placebo , erythema , discontinuation , light therapy , randomized controlled trial , adverse effect , dermatology , photodynamic therapy , red light , surgery , pathology , chemistry , botany , alternative medicine , organic chemistry , circadian rhythm , biology
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%).