Exosome and polynucleotide (PDRN) treatments are among the newest regenerative skin treatments — and one of the most regulation-sensitive, because in the US the FDA has not approved exosome products for aesthetic use. A clear exosome consent form that spells out the regulatory status protects your clients and your practice. Below is a free template, plus the complete kit.
What an exosome / PDRN consent form must include
- A clear regulatory-status statement (not FDA-approved; safety/efficacy not established)
- Procedure description and realistic, no-guarantee expectations
- Risks including allergic/immune reaction and unknown long-term effects
- Contraindications (pregnancy, active infection, immunosuppression, allergy)
- Product name and lot/batch number for traceability (in the treatment record)
- Signature, date, and photo/records consent
Free exosome / PDRN consent form template
Copy, print, or adapt the template below. For the editable version plus the other five forms, see the full kit.
Informed Consent: Exosome / PDRN Treatment
Client name: __________ DOB: ________ Date: ________
About the procedure. Exosome and polynucleotide (PDRN) treatments apply regenerative signaling compounds to the skin, usually right after microneedling, to support rejuvenation, tone, and texture. The specific product and lot number are recorded.
Regulatory status. I understand that exosome products are not approved by the FDA for aesthetic or therapeutic use, that their safety and long-term efficacy are not FDA-established, that the FDA has issued public safety warnings about unapproved exosome products, and that this treatment is elective and outside FDA-approved indications.
Realistic expectations & risks. Results vary and are not guaranteed; a series is usually needed. Risks include redness, swelling, itching, pinpoint bleeding (from microneedling), and less commonly allergic/immune reaction, infection, pigmentation change, and unknown long-term effects.
Contraindications (may decline if any apply): pregnancy/nursing, active infection or cold sore, known allergy to the product, active cancer/chemotherapy, autoimmune/immunosuppression, keloid history, isotretinoin within 6 months.
Consent. The procedure, risks, regulatory status, and alternatives have been explained; no guarantee is expressed or implied; this is an elective, non-refundable treatment. I have read and understand this form and consent to treatment. Valid until revoked in writing.
Client signature: __________ Date: ______ Provider/Witness: __________ Date: ______
Get the complete Exosome & PDRN Documentation Kit
The free consent above is one of six. The full editable kit covers your whole workflow:
- Informed Consent
- Client Intake & Health History
- Pre-Treatment Care
- Aftercare sheet + card
- Treatment Record
- Photo Consent & Release
Editable, plus fillable PDF and Word. Launching soon. Email outreach@proneedling.com for early access.
Frequently asked questions
Are exosomes FDA-approved for skin treatments?
No. In the US, the FDA has not approved exosome products for aesthetic or therapeutic use and has issued public safety warnings about unapproved exosome products. Any provider offering them should understand the regulatory status and reflect it in their consent form.
Do I need a consent form for exosome treatments?
Yes. Because exosome treatments are elective and outside FDA-approved indications, a clear informed-consent form covering the regulatory status, risks, and no-guarantee of results is especially important.
Can I edit this form?
Yes, copy and adapt the free template. The full kit is editable plus fillable PDF and Word.