title: Randomized, Double-Blind, Split-Face Study Evaluating Fractional Ablative Erbium:YAG Laser-Mediated Trans-Epidermal Delivery of Cosmetic Actives and a Novel Acoustic Pressure Wave Ultrasound Technology for the Treatment of Skin Aging, Melasma, and Acne Scars.
abstract: BACKGROUND
  Fractional laser resurfacing enhances trans-epidermal delivery (TED), however laser penetration depths >250- μm fail to substantively increase drug delivery.
  
  
  OBJECTIVE
  Evaluate the safety and efficacy of a novel acoustic pressure wave ultrasound device following fractional ablative Er:YAG 2940-nm laser (FELR) and topical agents for rhytids, melasma, and acne scars.
  
  
  METHODS
  Randomized, blinded, parallel group split-face side-by-side, controlled study evaluating FELR and topical anti-aging and anti-pigment agents to entire face succeeded by ultrasound to randomized side. Fifteen subjects were enrolled to three treatment arms:rhytids, melasma, and acne scars. Two monthly treatments were administered with 1, 3, and 6 month follow-up. Efficacy was assessed by Comprehensive Grading Scale of Rhytids, Laxity, and Photoaging by Investigator and two blinded physician evaluators. Subject assessments, digital photographs, and reflectance spectroscopic analyses were obtained.
  
  
  RESULTS
  Rhytid severity was reduced from a mean of 3.25 to 2.60 on the 4-point grading scale. Spectrophotometric analysis demonstrated increases in lightness (L*) and reductions in redness (a*) and pigment (b*), with greater improvements on the ultrasound side as compared to FELR and topicals alone. Moderate erythema post-treatment resolved in 7 days and no serious adverse events were observed.
  
  
  CONCLUSIONS
  In this randomized, paired split-face clinical study, FELR-facilitated TED of topical anti-aging actives with ultrasound treatment is safe and effective with improvement in rhytids, melasma, and acne scars. Statistically significant greater improvement in pigment levels was observed on the ultrasound side as compared to FELR-TED and topical agents alone.
authors.forename: Macrene
authors.initials: M
authors.lastname: Alexiades
mesh_terms: D000152:Acne Vulgaris / Q000150:complications; D000162:Acoustics; D000279:Administration, Cutaneous; D002921:Cicatrix / Q000188:drug therapy* / Q000209:etiology; D003358:Cosmetics / Q000008:administration & dosage*; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053844:Lasers, Solid-State / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008548:Melanosis / Q000188:drug therapy* / Q000473:pathology; D015595:Skin Aging / Q000187:drug effects*; D013997:Time Factors; D016896:Treatment Outcome; D014464:Ultrasonic Therapy / Q000379:methods
chemical_list: D003358:Cosmetics