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Treatment of Scars with Laser-Assisted Delivery of Growth Factors and Vitamin C: A Comparative, Randomised, Double-blind, Early Clinical Trial

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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.

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Availability of Data and Material

Raw data, additional tables, and graphics not included in this version are available for consultation.

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Acknowledgements

We thank Ivy Dantas Melo e Silva for her support in the post-treatment care of the patient and for being responsible for the randomization process in this study. We thank Luiz Alberto Machado Aleixo and Matheus Machado Barbosa Pereira for their support with the tables confection and formatting in this paper.

Funding

This research received no financial support.

Author information

Authors and Affiliations

  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

    Barbara Helena Barcaro Machado & Mohammad Najlah

  2. The School of Medicine, Faculty of Health, Education, Medicine and Social Care, Chelmsford campus, Bishop Hall Lane, Chelmsford, CM1 1SQ, UK

    Jufen Zhang & James Frame

  3. Rio de Janeiro, Brazil

    Barbara Helena Barcaro Machado

Authors
  1. Barbara Helena Barcaro Machado
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  2. Jufen Zhang
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  4. Mohammad Najlah
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Contributions

B.H.B.M. and M.N. contributed to the study conception and design. Material preparation, data collection, and analysis were performed by B.H.B.M. J.Z. performed the review of the statistical analysis. M.N. and J.F. performed the manuscript review. All authors read and approved the final manuscript.

Corresponding authors

Correspondence to Barbara Helena Barcaro Machado or Mohammad Najlah.

Ethics declarations

Conflict of interest

The authors have no financial interest or support related to this study. The three-dimensional stereophotogrammetry system and drugs have been fully paid by the first author as a part of a PhD study.

Ethical Approval

This study was approved by the Associação Congregração de Santa Catarina, Casa de Saúde São José Ethics Committee Rio de Janeiro, Brazil and registered at Plataforma Brazil. It was also approved by the Faculty Research Ethics Panel (FREP) at Anglia Ruskin University and followed the principles of the World Medical Association Declaration of Helsinki (2013). Participants received a comprehensive explanatory information sheet about the research and signed a consent form to engage in the study.

Consent to Participate

All patients have consented to participate and have signed a consent form that has been submitted to both Ethics committees.

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The photographs are property of the first author and can be published.

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Machado, B.H.B., Zhang, J., Frame, J. et al. Treatment of Scars with Laser-Assisted Delivery of Growth Factors and Vitamin C: A Comparative, Randomised, Double-blind, Early Clinical Trial. Aesth Plast Surg 45, 2363–2374 (2021). https://doi.org/10.1007/s00266-021-02232-4

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  • DOI: https://doi.org/10.1007/s00266-021-02232-4

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