Microneedling with VAMP™ multivitamin serum to improve facial skin health

A Prospective Clinical Study Evaluating the Effects of a Topical Multivitamin Serum, Containing PDRN on Facial Skin Hydration and Biophysical Parameters Following Microneedling

This will try microneedling combined with a topical VAMP™ multivitamin serum containing PDRN to improve facial skin hydration, elasticity, and radiance in adults who want better skin quality.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 22 Years to 65 Years
• Sex: All
• Sponsor: Erevna Innovations Inc. (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT07210190 on ClinicalTrials.gov

What this trial studies

Participants will receive microneedling treatments with topical application of VAMP™ Multivitamin Serum, a formulation that includes polydeoxyribonucleotide (PDRN), amino acids, vitamins, and peptides. Microneedling creates micro-channels to enhance topical delivery while the serum aims to support skin hydration, elasticity, and texture. Outcomes will be tracked with standardized biometric and photographic evaluations and participants must follow pre-visit instructions and contraception requirements for women of childbearing potential. The trial enrolls immune-competent adults aged 22 and older and is conducted at a single site in Montreal.

Who should consider this trial

Good fit: Ideal candidates are immune-competent adults aged 22 or older who want to improve facial skin appearance and can attend in-person visits and follow study instructions, including pre-visit shaving and contraception if applicable.

Not a fit: People with active skin infections, significant dermatologic disease, immune compromise, pregnant individuals, or those unwilling to follow pre-visit or contraception requirements are unlikely to benefit.

Why it matters

Potential benefit: If successful, the combination could improve facial skin hydration, elasticity, texture, and overall radiance and may reduce fine lines.

How similar studies have performed: Early clinical reports and case series of PDRN-containing skin boosters have shown regenerative and anti-inflammatory effects, but randomized controlled evidence for microneedling combined with PDRN is still limited.

Eligibility criteria

Inclusion Criteria:

1. Ability to adequately understand the verbal explanations and the written participant information provided in local language and ability and willingness to give consent to participate in the study. Signed and dated informed consent to participate in the study.
2. Participant interested in improving skin quality.
3. Immune-competent adult 22 years of age and older.
4. Has intent to undergo treatment to improve appearance of the facial skin.
5. Willingness to comply with pre-visit instructions, including shaving of facial area (for male participants), to allow for consistent biometric and photographic evaluations.
6. If the participant is a female of childbearing potential, she agrees to use an acceptable form of effective birth control for the duration of the study and is willing to take a urine pregnancy test (UPT) at Baseline and prior to receiving any study treatment.

   Acceptable forms of effective birth control include:
   * Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical caps) with spermicidal foam/gel/film/ cream/suppository;
   * Bilateral tubal ligation;
   * Combined oral contraceptives (estrogens and progesterone), implanted or injectable contraceptives on a stable dose for at least 28 days prior to Day 1;
   * Hormonal or copper intra uterine device (IUD) inserted at least 28 days prior to Day 1;
   * Vasectomized partner (in monogamous relationship) for at least 3 months prior to screening;
   * Strict abstinence (at least one month prior to baseline and agrees to continue for the duration of the study or use acceptable form of birth control).
7. Negative UPT for women of childbearing potential at the Baseline visit.
8. Stable lifestyle and skincare regimen for at least 4 weeks

Exclusion Criteria:1. Known or suspected allergy or hypersensitivity to any components of VAMP™ ADVANCED Topical Multivitamin Serum, including sodium hyaluronate, peptides, polynucleotides (e.g., PDRN), or excipients.

2\. Known allergy or intolerance to topical anesthetics or lidocaine. 3. History of hypersensitivity reactions such as anaphylaxis, angioedema, or other severe allergic responses.

4\. History of hypertrophic scarring, keloid formation, or post-inflammatory hyperpigmentation following cosmetic treatments.

5\. Tattoos, piercings, or skin bleaching agents in the treatment area that may interfere with assessments, as judged by the Investigator.

6\. Participants with known pigmentary instability or history of adverse response to microneedling.

7\. Previous cosmetic or dermatologic procedures in the treatment area within the following time frames: 8. Previous treatment with cross-linked hyaluronic acid dermal fillers in the treatment area within the last 12 months.

9\. Energy-based devices (laser, IPL, RF, ultrasound) in the last 6 months. 10. Microneedling, dermabrasion, mesotherapy, or chemical peels in the last 6 months.

11\. Use of topical corticosteroids, retinoids, or depigmenting agents in the treatment area within the past 4 weeks.

12\. Current use of immunosuppressive therapy, systemic corticosteroids, or chemotherapy within the last 3 months.

13\. History of systemic autoimmune, collagen vascular, or bleeding disorders (e.g., lupus, scleroderma, thrombocytopenia).

14\. Current pregnancy, positive urine pregnancy test at screening, breastfeeding, or intent to become pregnant during the study.

15\. Participation in another clinical study within the past 30 days or concurrent participation in another interventional trial.

16\. Any condition, including psychological, cognitive, or behavioral concerns, that would interfere with the ability to give informed consent, follow the protocol, or comply with follow-up requirements.

17\. Initiation of a weight loss program or GLP-1 agonist therapy within 30 days before baseline or planned during study period.

18\. Active skin conditions exacerbated by microneedling or transepidermal delivery, including chronic dermatitis or impaired barrier function.

19\. Current participation by study personnel, immediate family members, or employees of the Sponsor.

20\. Known allergy to fish or seafood, including but not limited to salmon, due to the potential presence of PDRN derived from marine sources.

21\. History of cancer or previous radiation near or on the area to be treated. 22. Heavy smokers, classified as smoking more than 12 cigarettes per day. 23. Presence of any disease or lesions near or on the area to be treated, e.g.

1. Inflammation, active or chronic infection in or near the treatment area
2. Psoriasis, eczema, herpes zoster and acanthosis
3. Cancer or precancerous condition (e.g. actinic keratosis)
4. Severe skin laxity, flaccidity, or sagging
5. Advanced photoaged/ photodamaged skin (e.g., advanced skin elastosis, multiple lentigo solaris lesions) or skin condition (e.g., very crinkled, very thin, fragile skin or severe skin atrophy) in the treatment area that in the Investigator's opinion could interfere with the safety or effectiveness of the study product or injection procedure.

   24\. Skin coloring/bleaching/tattoo in the treatment area, which, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessment.

   25\. An underlying known disease, a surgical or medical condition that would expose the participant to undue risk, e.g. history of bleeding disorders, active hepatitis, active autoimmune disease such as connective tissue diseases, systemic lupus erythematosus, polymyositis, dermatomyositis, multiple sclerosis or scleroderma.

   26\. Use of concomitant medication that have the potential to prolong bleeding times such as anticoagulants or inhibitors of platelet aggregation (e.g., warfarin, clopidogrel, aspirin, baby aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), Omega 3 or Vitamin E), within 14 days prior to injection. Omega 3 and Vitamin E are acceptable only as part of a standard Topical Multivitamin formulation. Cyclooxygenase-2 (COX 2) inhibitors are allowed.

   27\. Treatment with chemotherapy, immunosuppressive agents, systemic corticosteroids within 3 months before treatment (inhaled or ophthalmic corticosteroids are allowed).

   28\. Use of hormonal therapy (ex. HRT or contraceptives) unless the participant has been on a stable dose for at least 3 months prior to screening and does not plan to make any changes to the HRT regimen during the study period.

   29\. Use of topical corticosteroids, topical prescription retinoids in the treatment area within 1 month of the Baseline visit or systemic retinoid treatment within 6 months of the baseline visit, or plan to receive such treatment.

   30\. Pregnancy (confirmed by positive urine pregnancy test (UPT)/ serum pregnancy test), breast feeding or intends to become pregnant over the duration of the study.

Where this trial is running

Montreal, Quebec

• Erevna Innovations Inc. — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Andreas Nikolis, MD, PhD — Erevna Innovations Inc.
• Study coordinator: Laura Raco

Conditions Aesthetic; Topical; Polydeoxyribonucleotide; Skin booster; Skin; Hydration