Barbara Helena Barcaro Machado1,2, Jufen Zhang3, James Frame3, Mohammad Najlah4. 1. Pharmaceutical Research Group, Faculty of Health, School of Allied Health, Education, Medicine and Social Care, Anglia Ruskin University, Bishops Hall Lane, Chelmsford, CM1 1SQ, UK. bhb105@pgr.aru.ac.uk. 2. , Rio de Janeiro, Brazil. bhb105@pgr.aru.ac.uk. 3. The School of Medicine, Faculty of Health, Education, Medicine and Social Care, Chelmsford campus, Bishop Hall Lane, Chelmsford, CM1 1SQ, UK. 4. Pharmaceutical Research Group, Faculty of Health, School of Allied Health, Education, Medicine and Social Care, Anglia Ruskin University, Bishops Hall Lane, Chelmsford, CM1 1SQ, UK. mohammad.najlah@aru.ac.uk.
Abstract
BACKGROUND: Scarring can jeopardize the final result of plastic surgeries. Deep dermal injuries activate dermal fibroblasts that produce excessive amount of collagen and inflammatory cytokines and growth factors, which contributes to increased fibrous tissue and scarring tissue formation. OBJECTIVES: The aim of this early study, double-blind, prospective, randomised clinical trial was to investigate the use of laser-assisted drug delivery (LADD) for scar improvement to support the establishment of LADD as standard therapy modality and to indicate suitable drugs for dermal administration. MATERIAL AND METHODS: In total, 132 patients seeking scar treatment were consented and randomised. The control group (64 patients) received laser resurfacing immediately followed by skin surface application of Vitamin C and 68 patients received laser treatment followed by skin surface application of a cosmeceutical containing growth factors (GFs) and Vitamin C. Photographs were obtained before and three months after the procedure and submitted to three-dimensional reconstruction by the software Dermapix®. Objective measurements provided by the software were statistically analysed and established the differences in the treatment result between the two groups. RESULTS: There was a significant reduction in scar roughness and volume in both groups (p < 0.01). Mann-Whitney test confirmed that the group treated vitamin C and GFs presented significantly better results than the group treated with vitamin C alone (p < 0.01). CONCLUSION:LADD has proven efficient as scars were reduced in both study groups. Furthermore, the addition of growth factors provided statistically significant better outcomes and resulted in more inconspicuous scars. No adverse reactions were observed. CLINICAL TRIAL REGISTRATION: Plataforma Brasil under the number CAAE: 63710716.2.0000.5664. 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 .
RCT Entities:
BACKGROUND: Scarring can jeopardize the final result of plastic surgeries. Deep dermal injuries activate dermal fibroblasts that produce excessive amount of collagen and inflammatory cytokines and growth factors, which contributes to increased fibrous tissue and scarring tissue formation. OBJECTIVES: The aim of this early study, double-blind, prospective, randomised clinical trial was to investigate the use of laser-assisted drug delivery (LADD) for scar improvement to support the establishment of LADD as standard therapy modality and to indicate suitable drugs for dermal administration. MATERIAL AND METHODS: In total, 132 patients seeking scar treatment were consented and randomised. The control group (64 patients) received laser resurfacing immediately followed by skin surface application of Vitamin C and 68 patients received laser treatment followed by skin surface application of a cosmeceutical containing growth factors (GFs) and Vitamin C. Photographs were obtained before and three months after the procedure and submitted to three-dimensional reconstruction by the software Dermapix®. Objective measurements provided by the software were statistically analysed and established the differences in the treatment result between the two groups. RESULTS: There was a significant reduction in scar roughness and volume in both groups (p < 0.01). Mann-Whitney test confirmed that the group treated vitamin C and GFs presented significantly better results than the group treated with vitamin C alone (p < 0.01). CONCLUSION: LADD has proven efficient as scars were reduced in both study groups. Furthermore, the addition of growth factors provided statistically significant better outcomes and resulted in more inconspicuous scars. No adverse reactions were observed. CLINICAL TRIAL REGISTRATION: Plataforma Brasil under the number CAAE: 63710716.2.0000.5664. 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 .
Entities:
Keywords:
Growth factors; Laser-assisted drug delivery; Scar treatment; Scars; Vitamin C