Controlled Clinical Trial Evaluating the Efficacy of Microneedling Combined with Exosomes Versus Microneedling Alone in the Treatment of Melasma

  1. Bianca de Oliveira Ferraz Gominho
  2. Ana Cristina França Medeiros

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Abstract

Melasma is a chronic pigmentary disorder that presents significant therapeutic challenges due to its recurrent nature and variable response to conventional treatments. It predominantly affects photo exposed facial areas and often impacts patient’s quality of life. Microneedling is an established technique for melasma management, promoting skin renewal and enhancing the transdermal delivery of depigmenting agents. Recently, exosomes have emerged as a novel therapeutic approach with regenerative and pigment-modulating potential. This pilot randomized controlled clinical trial aimed to assess the efficacy and safety of microneedling combined with topical exosomes compared to microneedling alone in the treatment of melasma. Twelve female participants were randomized into two groups: one treated with microneedling and topical application of exosomes, the other with microneedling and saline solution as control group. Outcomes were evaluated through clinical assessment using MASI and GAIS scales. The combination group showed greater reduction in melasma severity and improved aesthetic appearance than the control group. No adverse effects were reported. These findings suggest that exosomes may enhance the therapeutic efficacy of microneedling. This approach represents a promising and safe alternative for melasma management and supports further investigation into exosome-based dermatological therapies.

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  1. PREreview

    This Zenodo record is a permanently preserved version of a Structured PREreview. You can view the complete PREreview at https://prereview.org/reviews/15813386.

    Does the introduction explain the objective of the research presented in the preprint? Yes
    Are the methods well-suited for this research? Highly appropriate
    Are the conclusions supported by the data? Highly supported
    Are the data presentations, including visualizations, well-suited to represent the data? Highly appropriate and clear
    How clearly do the authors discuss, explain, and interpret their findings and potential next steps for the research? Somewhat clearly
    Is the preprint likely to advance academic knowledge? Highly likely
    Would it benefit from language editing? No
    Would you recommend this preprint to others? Yes, it's of high quality
    Is it ready for attention from an editor, publisher or broader audience? Yes, as it is

    Competing interests

    The author declares that they have no competing interests.

  2. Version published to 10.20944/preprints202505.0934.v1