Regenerative topical products are trending. In a Next Steps in Derm interview, in partnership with the ODAC Dermatology Conference, Terrence Keaney, MD, FAAD, outlines topicals that have rejuvenating properties. Hear Dr. Keaney’s take on exosomes, platelet-derived growth factors (PDGF), and polydeoxyribonucleotide (PDRN), and why these products should only be applied topically. Find out the latest safety data on PDGF, and the current state of PDRN sourcing and efficacy data. Be up to date with your most voguish patient by watching this interview.
Further Reading
If you want to read more about skin rejuvenation, check out the following articles published in the Journal of Drugs in Dermatology:
Regulatory Landscape of Regenerative Dermatology: Current Frameworks and Future
ABSTRACT
Background: Regenerative dermatology is an emerging subspecialty that seeks to restore the structure and function of healthy skin. The United States lacks comprehensive regulatory guidance for regenerative therapies. This review provides an overview of available therapies within regenerative dermatology, outlining the pathways for approval.
Methods: Articles on regenerative dermatology in PubMed and guidelines issued by the United States Food and Drug Administration (FDA) were reviewed with emphasis on those published between June 2020 and June 2025, and results were summarized in narrative format.
Results: In the United States, the FDA is the primary regulatory authority responsible for ensuring the safety and efficacy of regenerative biotherapeutics. Classification of a product as a drug, biologic, device, or cosmetic determines the regulatory pathway it must follow.
Discussion: Cosmetics are intended to promote attractiveness without treating or preventing disease and do not require FDA approval prior to marketing, while drugs and biologics undergo a multi-step process to obtain approval: (1) product development, (2) preclinical testing in a laboratory setting, (3) clinical trials involving human subjects, (4) FDA review, and (5) FDA approval. High-risk devices require a Premarket Approval (PMA), while low-to-moderate risk devices have less stringent requirements.
Conclusion: Regenerative dermatology offers significant therapeutic potential. Regulation is governed by the US FDA and varies according to product classification. Clinicians should counsel patients on safety and efficacy data prior to initiating regenerative treatments.
Exosomes in Cosmetic Dermatology: A Review of Benefits and Challenges
ABSTRACT
Background: Exosomes are small extracellular vesicles (30-150 nm in size) that play a critical role in cellular communication, transporting proteins, lipids, and nucleic acids between cells. This literature review focuses on evaluating the potential benefits and limitations of exosomes in enhancing skin health and aesthetics through indications such as skin rejuvenation, hair restoration, and pigmentation disorders.
Methods: A thorough literature search was conducted on PubMed using specific MeSH, including “exosomes,” “aesthetics,” “cosmetic dermatology,” “skin rejuvenation,” “hair growth,” and “wrinkle reduction.” The search was limited to free-access studies published in various countries within the last ten years (2014-2024). As a result, a total of 56 relevant references were identified and reviewed to support the discussion.
Results: There are currently no US Food and Drug Administration (FDA) approved exosomes. This review highlights exosomes’ potential in skin rejuvenation through extracellular matrix production and matrix metalloproteinases (MMP) inhibition, as well as in hair restoration by stimulating follicle cell activity and modulating inflammation. Despite these benefits, challenges remain, including inconsistent isolation methods, source variability, and the need for clinical trials to confirm long-term safety and efficacy. The regulatory landscape is evolving, and further research is essential to meet standards before exosomes can be broadly adopted in cosmetic dermatology.
Conclusion: While exosomes hold significant potential for non-invasive cosmetic dermatology, there are challenges that need to be addressed, including the standardization of exosome isolation and characterization, the establishment of safety profiles, and the conduct of extensive clinical trials.
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