A dermatology practice adding exosomes settles eight questions before the first session, and the published record behind them is thin but specific: a 2026 systematic review found 16 human studies with 503 participants, no serious adverse events, and low or very low certainty of evidence [1]. The two controlled split-face trials that define the usual sequence, topical material after fractional CO2 laser in 25 adults and after microneedling in 28 adults, each used one manufacturer’s product [5, 6].
A board-certified dermatologist, or the administrator working with one, deciding how a physician office adds a topical exosome step to procedures it already performs will find each question set out below with its evidence. Each question names why it matters and what a documented answer looks like, so the practice can file the answers alongside its device records, consent forms and chart templates. ExaVeyra Sciences supplies exosome material for topical aesthetic use by licensed practitioners, and every clinical decision described here belongs to the practitioner.
Regulatory status
The FDA stated in its 2019 public safety notification that there are currently no FDA-approved exosome products [15]. ExaVeyra supplies exosome material for topical aesthetic use by licensed practitioners, described by its available formats, with the lot number on every vial and a certificate of analysis for every lot; the certificate, characterization panel and cold-chain records are available on request. The FDA microneedling page states that the devices are not approved for delivering topical products into the skin [16], and whether and how any material is used in a given office is the practitioner’s decision.
1. Which board-certified physician owns the protocol, and to whom is each step delegated?
In a dermatology office the supervising physician is usually on site, which changes the delegation question from whether a physician is involved to how the written protocol assigns each step. Choudhry and colleagues interviewed 31 state medical boards and reported in 2012 that 20 allowed all minimally invasive cosmetic procedures to be delegated at the physician’s discretion, while 13 required some form of on-site supervision [9].
The outcome data favor a named operator for each step. Aleisa and colleagues surveyed 4,062 people in 2023 and reported that moderate adverse events were more frequent when nonphysicians performed cosmetic procedures, 73.3 against 51.8 percent of reported complications [11], and Rossi and colleagues reported more burns and discoloration among consumers seen by nonphysicians, with improper technique the most cited reason [10].
Malik and colleagues reviewed state statutes, administrative codes and board guidance in 2025 and reported significant variability in supervising physician roles and nonphysician scope of practice [8]. A documented answer names the physician who signs the protocol, the registered nurse or esthetician who performs the preceding procedure and the topical step, the supervision level for each, and the state board rule the assignment rests on.
2. Which published studies describe the sequence this office intends to follow?
The dermatology literature contains two controlled trials that match the way most offices add the step. Kwon and colleagues ran a double-blind randomized split-face trial in 25 adults in 2020, applying an adipose stem cell exosome gel after each of three fractional CO2 sessions, and reported greater scar improvement on the exosome side with milder erythema and shorter downtime [5].
Park GH and colleagues randomized 28 adults in 2023 to an exosome solution or saline on opposite sides of the face across three microneedling sessions three weeks apart, and reported higher aesthetic improvement scores and instrument-measured gains in wrinkles, elasticity, hydration and pigmentation on the exosome side [6]. Both trials used a single named product, so their results describe that material and that interval.
Wang, Bajwa and Rivers mapped 17 human dermatology studies in 2026 and reported that 76 percent recorded improvement in wrinkles, pigmentation, elasticity, hydration or scars, with adverse events uncommon and the serious events following injection [4]. A documented answer cites the study whose sequence the protocol follows, names the differences between that study’s product and the material in the office, and states that the route stays topical.
3. Which device record covers the microneedling or laser step, and what does the clearance exclude?
A dermatology office already keeps device records, and the exosome step attaches to one of them. The FDA classified aesthetic microneedling devices at 21 CFR 878.4430 through the De Novo authorization of the SkinPen Precision System in 2018 [18], and the codified identification states that the classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs or biologics [17].
The FDA microneedling page lists the appearance uses the agency has authorized, facial acne scars, facial wrinkles and abdominal scars in patients aged 22 or older, and states that the devices are not approved for delivery of cosmetics, topical medications, drugs or blood products into the skin [16]. SkinPen is a trademark of its owner and is named only to identify the device record.
A documented answer files the device’s 510(k) or De Novo number, its labeled indications and body areas, and the manufacturer’s instructions for use beside the protocol, and the protocol describes the topical step as aftercare chosen by the physician and keeps the device record to the functions its clearance names.
4. What does the supplier’s lot documentation show, and who reads it?
Knauer and colleagues surveyed 20 commercial topical exosome products in 2026 and reported minimal information on isolation, processing or shelf life [3]. That finding is the reason a dermatology office assigns a named reader to the documents for each lot before they are filed.
The MISEV2023 guideline from the International Society for Extracellular Vesicles sets out reporting headings for separation method, particle size and concentration, marker proteins and morphology, which give the reader a neutral checklist for a certificate of analysis [13]. ExaVeyra prints the lot number on every vial, generates a certificate of analysis for every lot with serology, and makes the certificate, characterization panel and cold-chain records available on request.
| Question | Why it matters | What a documented answer looks like |
|---|---|---|
| Which physician owns the protocol, and who performs each step? | Delegation rules vary by state board, and moderate adverse events were reported more often after nonphysician procedures [9, 11] | A signed protocol naming the physician, each operator, the supervision level and the state board rule |
| Which published sequence does the protocol follow? | The controlled trials describe one product, three sessions and a topical route [5, 6] | The study citation, the differences from the office’s material, and a stated topical route |
| Which device record covers the preceding procedure? | The classification excludes transdermal delivery of topical products [17] | The 510(k) or De Novo number, labeled indications and instructions for use on file |
| What do the lot documents show? | Commercial products carried minimal processing information [3] | The certificate of analysis, characterization panel and cold-chain records for the lot, read against MISEV2023 [13] |
| How are consent, photographs and the chart entry standardized? | Serial photographs are comparable only when positioning and lighting are fixed [12] | A consent form that matches the website, a photography procedure and a chart template with a lot field |
| How is the material stored? | Storage buffer and temperature changed vesicle recovery in a 2022 stability study [14] | A dedicated freezer at the labeled temperature, a daily log and an excursion plan |
| How is an adverse event reported? | MedWatch accepts voluntary reports from health professionals [19] | A named reporter, the lot number in the report, and the supplier notified |
5. Which questions does the published evidence leave open?
A dermatologist explaining the service to a patient or a peer is on firmer ground when the limits are stated with the literature. The points below set out what the published evidence does not yet show.
- Certainty is low: Gaebe and colleagues rated the evidence across 16 studies and 503 participants as low or very low certainty, with risk of bias moderate to critical [1].
- Protocols are not standardized: Stack and colleagues pooled 39 human studies and reported a 20.2 percent average wrinkle reduction alongside heterogeneity and nonstandardized protocols, so no interval, quantity or number of sessions is established [2].
- Products differ: the market survey by Knauer and colleagues found minimal information on isolation, processing and shelf life across 20 products, so a result for one product may not transfer to another [3].
- Industry ties are common: the gels in the Kwon 2020 trial were supplied by the exosome manufacturer [5].
- Follow-up is short: the two controlled trials ran for 12 weeks, and the 2026 scoping review described small samples and short follow-up across the field [4, 5, 6].
- Route matters: Park KY described four women with persistent erythema, nodules and granulomatous inflammation after intradermal injection of products sold for topical use, in nonclinical settings [7].
- No dermatology society position was located: a PubMed search on the audit date found no American Academy of Dermatology position statement on exosome products, so practices rely on the primary literature and the FDA pages.
6. How are consent, photodocumentation and the chart entry standardized?
The consent form, the website and the chart template should describe the same service in the same words, naming the preceding procedure and the topical step as aftercare the physician chose. The FDA notification states that exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products [15], so consent language that describes appearance and names no condition keeps the three documents consistent.
Dermatology already has a consensus model for serial photography. van Geel and colleagues published an international vitiligo photography protocol in 2020 with a core set of 10 photographs for clinical practice and 15 for research, with fixed positioning, background color, lighting, position marking and scales [12], and those technical elements can be adapted to a before-and-after record for a new topical service.
A documented chart entry carries the procedure, the device settings, the lot number of the material applied, the operator and the supervising physician. In an EHR, a discrete lot field is what lets the office search every patient who received a given lot if the supplier or the FDA ever asks.
7. How is the material stored between sessions, and who keeps the temperature log?
Görgens and colleagues studied vesicle storage for up to two years and reported in 2022 that plain phosphate-buffered saline reduced vesicle recovery, while buffer with human albumin and trehalose preserved vesicles at minus 80 degrees and across freeze-thaw cycles [14]. The practical reading for an office is to follow the manufacturer’s handling instructions exactly and avoid repeated thawing.
ExaVeyra orders ship overnight frozen on dry ice and arrive in 1 to 3 business days, and the receiving procedure checks that dry ice remains, records the arrival time and lot number, and moves the vials to the freezer before anything else happens. A documented answer names the freezer, the person who records the temperature on every working day, and the plan for an excursion, including which lot numbers it affected.
8. How is an adverse event recorded and reported, and to whom?
The reviews report that adverse events were uncommon, with no serious adverse events in the 2026 systematic review, and that the serious events in the dermatology literature followed injection [1, 4]. A practice still writes down in advance who records a reaction, what the record contains and where it is sent.
The FDA’s MedWatch program accepts voluntary reports from health professionals covering biologics, medical devices and cosmetics [19]. A documented answer names the reporter, requires the lot number in every report, notifies the supplier so the lot can be traced, and files the report with the chart.
A dermatology office adds the topical step to records it already keeps: the device file, the consent form, the photography procedure and the chart. The eight answers above are what make the new service as traceable as the procedures around it.
A verified account places the documents in the file before the first session
The checklist below gathers the eight questions into items a practice manager can tick off. Each one has an owner in the table above.
- The signed protocol names the supervising physician, each operator and the state board rule for the delegation.
- The protocol cites the published sequence it follows and states the topical route.
- The device record for the preceding procedure, with its labeled indications, is filed beside the protocol.
- The certificate of analysis, characterization panel and cold-chain records for the current lot have been requested and read.
- The consent form, website and chart template describe the same service, and the chart has a discrete lot field.
- The photography procedure fixes positioning, lighting and background, and the first baseline set is taken before the first session.
- The freezer log is running, and the excursion plan is written.
- The adverse event route names a reporter and requires the lot number.
A dermatology practice that applies for a verified account can have these documents on file before the first booking. Anyone may ask the scientific team a question or apply without an NPI, review takes 1 to 3 business days, and NPI verification gives access to the practitioner portal, product documentation and pricing for each available format.
Practices that start with the device record, the consent form and the lot file already in order are well placed to grow the service as the evidence matures, and to contribute the kind of standardized records the field still needs.
Aviso Educativo: This article is for educational purposes only and does not constitute medical or legal advice. It does not identify any material, compound, device setting or protocol as safe, effective or appropriate for any patient, and it is not intended to diagnose, treat, cure, or prevent any disease. Questions about a treatment belong with the reader’s own licensed provider. Exosome material is supplied for topical aesthetic use by licensed practitioners. No exosome product is FDA-approved for any use, and ExaVeyra Sciences makes no statement about administration, route, or outcome. Compounded medications are not FDA-approved. They are prepared by a 503A compounding pharmacy licensed by the Texas State Board of Pharmacy for an individual patient against that patient’s prescription, and are available to NPI-verified licensed practitioners only, in the states where the pharmacy is licensed. Product, device and brand names mentioned are trademarks of their respective owners and are used only to identify the products discussed. Their mention is not an endorsement, and those owners have not reviewed or endorsed this article. ExaVeyra Sciences is a supplier and takes no part in any diagnosis, treatment decision, or plan of care. Findings described are attributed to the peer-reviewed literature, trial registries and agencies cited. The content of these guides is provided for general informational purposes only. It does not constitute legal, medical, or regulatory advice, and does not establish that any particular product or practice is compliant. Regulatory requirements vary by state and depend on the circumstances of each practice. Each practitioner should consult their own legal counsel and the applicable state licensing boards before acting on anything stated here.
Referencias
- 1.Gaebe K, Lowe K, Bosnalie D, Khoury S, Villemure Poliquin N, Nichols A. Effectiveness and Safety of Extracellular Vesicle-Based Therapies for Nonsurgical Facial Rejuvenation: A Systematic Review. Facial Plast Surg Aesthet Med. 2026. Published online ahead of print. PMID 42487416. doi:10.1177/26893614261457879PRISMA systematic review with risk-of-bias and GRADE assessment, searches to June 2025; 16 studies, 503 participants. Carries in this article: most studies reported improvement in at least one skin-quality outcome, no serious adverse events were reported, risk of bias was moderate to critical and certainty was low or very low. Disclosure: academic authors (Canada); no conflict statement in the PubMed record.
- 2.Stack ER, Spongberg C, Braud SC, Stanton WN, Elway M. Clinical Advances in Exosome-Based Therapies for Aesthetic Medicine: A Systematic Review and Meta-analysis of Human Clinical Trials. Aesthet Surg J. 2026;46(12 Suppl 2):S13-S25. PMID 41800726. doi:10.1093/asj/sjaf178Systematic review and random-effects meta-analysis, searches to February 2025; 39 human studies. Carries in this article: a pooled facial wrinkle reduction of 20.2 percent, with heterogeneity and nonstandardized protocols noted by the authors. Disclosure: published in a journal supplement devoted to exosomes; no funding statement in the PubMed record.
- 3.Knauer G, Chang A, Gupta A, Brownstone N, Mejia N, Bauman S, et al. Clinical Evidence and Commercial Landscape of Topical Exosomes for Skin Rejuvenation: A Scoping Review. Aesthet Surg J. 2026;46(11):NP148-NP157. PMID 42411735. doi:10.1093/asj/sjag141Scoping review of 18 human studies plus a market survey of 20 commercial topical exosome products. Carries in this article: the products carried minimal information on isolation, processing or shelf life, the reason the receiving procedure reads lot documents before the first session. Disclosure: academic authors (USA); no conflict statement in the PubMed record.
- 4.Wang OJE, Bajwa BB, Rivers JK. Exosome-Based Therapies in Dermatology: A Scoping Review. J Drugs Dermatol. 2026;25(4):368-376. PMID 41931695. doi:10.36849/jdd.9610PRISMA-ScR scoping review of human studies in dermatology published 2020 to 2025; 17 studies. Carries in this article: 76 percent of studies recorded improvement in wrinkles, pigmentation, elasticity, hydration or scars, adverse events were uncommon, and the serious events listed (granulomas, necrosis, allergic reactions) followed injection. Disclosure: the authors noted potential conflicts of interest in the primary studies; none stated for themselves in the PubMed record.
- 5.Kwon HH, Yang SH, Lee J, Park BC, Park KY, Jung JY, et al. Combination Treatment with Human Adipose Tissue Stem Cell-derived Exosomes and Fractional CO2 Laser for Acne Scars: A 12-week Prospective, Double-blind, Randomized, Split-face Study. Acta Derm Venereol. 2020;100(18):adv00310. PMID 33073298. PMC9309822. doi:10.2340/00015555-3666Prospective, double-blind, randomized, split-face trial over 12 weeks with three fractional CO2 sessions (Korea); n = 25. Carries in this article: the published sequence of a topical exosome gel applied after a laser session, with greater scar improvement, milder erythema and shorter downtime reported on the exosome side. Disclosure: the exosome and control gels were manufactured and supplied by the exosome manufacturer; the authors declared no conflicts of interest.
- 6.Park GH, Kwon HH, Seok J, Yang SH, Lee J, Park BC, et al. Efficacy of combined treatment with human adipose tissue stem cell-derived exosome-containing solution and microneedling for facial skin aging: A 12-week prospective, randomized, split-face study. J Cosmet Dermatol. 2023;22(12):3418-3426. PMID 37377400. doi:10.1111/jocd.15872Prospective, randomized, split-face study over 12 weeks, three microneedling sessions three weeks apart, saline control side (Korea); n = 28. Carries in this article: the published sequence after microneedling, with higher aesthetic improvement scores and instrument-measured gains in wrinkles, elasticity, hydration and pigmentation on the exosome side. Disclosure: National Research Foundation of Korea grants listed in the PubMed record.
- 7.Park KY. Adverse Reactions Following Intradermal Injection of Exosome-Based Formulations: A Case Series. J Cosmet Dermatol. 2025;24(10):e70520. PMID 41097876. PMC12528963. doi:10.1111/jocd.70520Case series; adult women after intradermal injection of exosome-containing cosmetic products in nonclinical settings (South Korea); n = 4. Carries in this article: persistent erythema, nodules and granulomatous inflammation reported when products sold for topical use were used by another route, the reason the written protocol keeps to the labeled topical use. Disclosure: the author declared no conflicts of interest.
- 8.Malik AM, Ferrante AM, Booker BM, Council ML, Michalski-McNeely BM. Medical Spa Legislation, Regulations, and Guidelines in the United States. Dermatol Surg. 2025;51(8):785-790. PMID 40304398. doi:10.1097/DSS.0000000000004648Legal review of state statutes, administrative codes, case law and professional board guidance by dermatology and law school authors; no participants. Carries in this article: significant state variability in supervising physician roles and nonphysician scope of practice, the reason a dermatology office confirms its delegation against its own state board. Disclosure: none stated in the PubMed record.
- 9.Choudhry S, Kim NA, Gillum J, Ambavaram S, Williamson E, Yoo S, et al. State medical board regulation of minimally invasive cosmetic procedures. J Am Acad Dermatol. 2012;66(1):86-91. PMID 21798624. doi:10.1016/j.jaad.2011.01.009Structured interviews with officials of US allopathic state medical boards; 31 of 50 boards took part. Carries in this article: 20 boards reported that all minimally invasive cosmetic procedures could be delegated at the physician’s discretion to at least one category of nonphysician, while 13 required some form of on-site supervision. Disclosure: non-US government research support listed in the PubMed record.
- 10.Rossi AM, Wilson B, Hibler BP, Drake LA. Nonphysician Practice of Cosmetic Dermatology: A Patient and Physician Perspective of Outcomes and Adverse Events. Dermatol Surg. 2019;45(4):588-597. PMID 30946699. PMC6450566. doi:10.1097/DSS.0000000000001829Internet surveys of consumers and of American Society for Dermatologic Surgery members; 2,116 consumers began the survey, 401 had had a cosmetic procedure, and 50 adverse events were reported. Carries in this article: more burns and discoloration in the group seen by nonphysicians, with improper technique the most cited reason; recall bias noted by the authors. Disclosure: NIH extramural support listed in the PubMed record.
- 11.Aleisa A, Lu JT, Al Saud A, Veldhuizen IJ, Rossi AM, Lee KC. The Differences in the Practice of Cosmetic Dermatologic Procedures Between Physicians and Nonphysicians. Dermatol Surg. 2023;49(12):1165-1169. PMID 37883805. doi:10.1097/DSS.0000000000003948Cross-sectional web survey; 4,062 participants, of whom 1,328 reported a previous cosmetic procedure (828 by a physician, 413 by a nonphysician). Carries in this article: moderate adverse events were reported more often after procedures performed by nonphysicians (73.3 against 51.8 percent of complications), the reason the delegation record names the operator for each step. Disclosure: none stated in the PubMed record.
- 12.van Geel N, Hamzavi I, Kohli I, Wolkerstorfer A, Lim HW, Bae JM, et al. Standardizing serial photography for assessing and monitoring vitiligo: A core set of international recommendations for essential clinical and technical specifications. J Am Acad Dermatol. 2020;83(6):1639-1646. PMID 31678332. doi:10.1016/j.jaad.2019.10.055International vitiligo photography consensus protocol reviewed by 20 experts; a set of 10 photographs for clinical practice and 15 for research, with standardized positioning, background, lighting, position marking and scales. Carries in this article: the elements of a serial photography procedure that a dermatology office can adopt for a new topical service, drawn from a peer-reviewed dermatology consensus written for vitiligo and adapted here to a topical service. Disclosure: published under the American Academy of Dermatology; conflicts listed in the article.
- 13.Welsh JA, Goberdhan DCI, O'Driscoll L, Buzas EI, Blenkiron C, Bussolati B, et al; MISEV Consortium; Théry C, Witwer KW. Minimal information for studies of extracellular vesicles (MISEV2023): From basic to advanced approaches. J Extracell Vesicles. 2024;13(2):e12404. PMID 38326288. PMC10850029. doi:10.1002/jev2.12404International Society for Extracellular Vesicles reporting guideline, compiled with ISEV task forces and more than 1,000 researchers. Carries in this article: the reporting headings (separation, particle size and concentration, marker proteins, morphology) a practice reads a certificate of analysis against. Disclosure: many consortium authors list EV company affiliations, declared in full in the article.
- 14.Görgens A, Corso G, Hagey DW, Jawad Wiklander R, Gustafsson MO, Felldin U, et al. Identification of storage conditions stabilizing extracellular vesicles preparations. J Extracell Vesicles. 2022;11(6):e12238. PMID 35716060. PMC9206228. doi:10.1002/jev2.12238In vitro stability study over up to 2 years across buffers and temperatures, EVs from several cell sources. Carries in this article: plain phosphate-buffered saline reduced vesicle recovery while buffer with human albumin and trehalose preserved vesicles at minus 80 degrees and across freeze-thaw cycles, the reason the freezer log and handling instructions matter. Disclosure: several authors list affiliation with an EV therapeutics company.
- 15.U.S. Food and Drug Administration. Public Safety Notification on Exosome Products. December 6, 2019 (content current as of 12/06/2019; verified 4 November 2026). https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-productsAgency safety notification (CBER). Carries in this article: the agency statement that there are currently no FDA-approved exosome products, and that exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products, the reason office copy names no condition.
- 16.U.S. Food and Drug Administration. Microneedling Devices. Content current as of 10/15/2025; verified 4 November 2026. https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/microneedling-devicesAgency device information page (CDRH). Carries in this article: the FDA has legally authorized microneedling devices to improve the appearance of facial acne scars, facial wrinkles and abdominal scars in patients aged 22 or older, and the page states that the devices are not approved for delivery of topical products into the skin.
- 17.U.S. Food and Drug Administration. 21 CFR 878.4430, Microneedling device for aesthetic use. Text verified on eCFR 4 November 2026 (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-878/subpart-E/section-878.4430). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=878.4430Codified device classification (Class II, special controls). Carries in this article: the identification text, which states that the classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs or biologics, and the labeling special controls a practice files with its device record.
- 18.U.S. Food and Drug Administration. De Novo Classification Request DEN160029, SkinPen Precision System (powered microneedle device, 21 CFR 878.4430, product code QAI). Decision date March 1, 2018; record verified 4 November 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN160029Agency De Novo database record (CDRH). Carries in this article: the authorization through which aesthetic microneedling devices were classified at 21 CFR 878.4430, an example of the device record a dermatology office files beside its protocol. The device name is a trademark of its owner.
- 19.U.S. Food and Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Content current as of 11/03/2026; verified 4 November 2026. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-programAgency reporting program page. Carries in this article: the voluntary reporting route for health professionals, patients and consumers covering biologics, medical devices and cosmetics, the route a practice documents for any adverse event recorded with its lot number.