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AestheticPhase 4NCT07210190

Microneedling for Skin Heath

A Phase 4 study testing Microneedeling with topical application of VAMP™ Topical Multivitamin Serum in people with Aesthetic, run by Erevna Innovations Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Skin boosters are treatments designed to improve skin quality and restore skin health. Some of these treatments are based on polynucleotides, which are small fragments of DNA. One such compound, called Polydeoxyribonucleotide (PDRN), is obtained from fish sources such as salmon or trout. Read more about this study

Who is it for?
Ages 22 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Aesthetic
What is being tested?
Microneedeling with topical application of VAMP™ Topical Multivitamin Serum
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
17 Jan 2026to 2 Jul 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • Participant interested in improving skin quality.
  • Immune-competent adult 22 years of age and older.
  • Has intent to undergo treatment to improve appearance of the facial skin.
  • Willingness to comply with pre-visit instructions, including shaving of facial area (for male participants), to allow for consistent biometric and photographic evaluations.
  • 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.
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  • 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).
  • Negative UPT for women of childbearing potential at the Baseline visit.
  • 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.
  • Inflammation, active or chronic infection in or near the treatment area
  • Psoriasis, eczema, herpes zoster and acanthosis
  • Cancer or precancerous condition (e.g. actinic keratosis)
  • Severe skin laxity, flaccidity, or sagging
  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Erevna Innovations Inc.

    Montreal, Quebec, H3Z 1C3

Other trials in Canada

About this study

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

Skin boosters are treatments designed to improve skin quality and restore skin health. Some of these treatments are based on polynucleotides, which are small fragments of DNA. One such compound, called Polydeoxyribonucleotide (PDRN), is obtained from fish sources such as salmon or trout. PDRN has shown regenerative and anti-inflammatory properties, and in medical practice it has been used to support wound healing, scar improvement, and skin rejuvenation by helping with elasticity, texture, and fine lines.

VAMP™ Multivitamin Serum is a topical formulation that contains PDRN along with amino acids, vitamins, and peptides. It is designed to improve hydration, elasticity, and overall skin radiance. While early data suggest potential benefits, clinical research is still limited, and further study is needed.

Conditions
Aesthetic
Being tested
Microneedeling with topical application of VAMP™ Topical Multivitamin Serum
Keywords
Topical, Polydeoxyribonucleotide, Skin booster, Skin, Hydration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microneedeling with topical application of VAMP™ Topical Multivitamin SerumDevice

    VAMP™ Topical Multivitamin Serum is not indicated for use in pregnancy, lactation, or in individuals under the age of 22. Female participants of childbearing potential will be required to undergo urine pregnancy testing at baseline and prior to each treatment session. They will also be instructed to use an acceptable form of effective contraception for the duration of the study.

Study groups in NCT07210190
Study groupRoleWhat they receive
Group A - biweekly treatment scheduleActive comparatorParticipants in this group will undergo an initial microneedeling session followed by a topical application of standardized, non-crosslinked hyaluronic acid. Following this initial treatment participants in Group A will receive three treatments of microneedeling immediately followed by topical application of VAMP™ Topical Multivitamin Serum every two (2) weeks
Receives: Device: Microneedeling with topical application of VAMP™ Topical Multivitamin Serum
Group B - month treatment scheduleActive comparatorParticipants in this group will undergo an initial microneedeling session followed by a topical application of standardized, non-crosslinked hyaluronic acid. Following this initial treatment participants in Group B will receive three treatments of microneedeling immediately followed by topical application of VAMP™ Topical Multivitamin Serum every four (4) weeks
Receives: Device: Microneedeling with topical application of VAMP™ Topical Multivitamin Serum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Skin Hydration From Baseline

    Percentage change in skin hydration from Baseline following microneedling with sequential applications of VAMP™ Topical Multivitamin Serum, measured using the Corneometer CM 825 (Courage+Khazaka electronic GmbH).

    Measured: Baseline to final follow-up (Week 10 for Group A; Week 16 for Group B)

Secondary outcomes (7)

  1. Change in Transepidermal Water Loss (TEWL) From Baseline

    Percentage change in TEWL from Baseline, measured using the Tewameter TM 21

    Measured: Baseline to final follow-up (Week 10 for Group A; Week 16 for Group B)

  2. Change in Skin Surface Biophysical Parameters From Baseline

    Percentage change in surface evaluation of living skin cells (SELS: roughness, scaliness, smoothness, desquamation, and pore size), measured via the VisioScan VC 98.

    Measured: Baseline to final follow-up (Week 10 for Group A; Week 16 for Group B)

  3. Change in Skin Elasticity From Baseline

    Percentage change in skin elasticity from Baseline, measured using the Cutometer Dual MPA 580.

    Measured: Baseline to final follow-up (Week 10 for Group A; Week 16 for Group B)

  4. Participant Satisfaction With Treatment

    Proportion of participants who report being at least "satisfied" (satisfied, very much satisfied, or extremely satisfied) on a seven-point participant satisfaction scale

    Measured: Week 2 to Week 10 for Group A; Baseline to Week 16 for Group B

  5. Global Aesthetic Improvement Scale (GAIS) Score Assessed by Blinded Evaluator

    Proportion of participants rated as "improved" (improved, much improved, or very much improved) on the GAIS by a blinded evaluator at the end of the study

    Measured: Baseline to Week 10 for Group A; Baseline to Week 16 for Group B

  6. Safety and Tolerability of Treatment

    Incidence and frequency of adverse events

    Measured: Baseline to final follow-up (Week 10 for Group A; Week 16 for Group B)

  7. Change in VISIA® CR Facial Imaging Metrics

    Percentage change from Baseline in VISIA® CR-derived facial metrics as assessed by non invasive analysis of facial images

    Measured: Baseline to final follow-up (Week 10 for Group A; Week 16 for Group B)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2025
  2. Study start17 Jan 2026
  3. Primary completion2 Jul 2026
  4. Study completion2 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07210190
Sponsor's protocol ID
PRO-2025-VAMP-02
Status last verified
Jan 2026
First submitted
29 Sep 2025
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Microneedeling with topical application of VAMP™ Topical Multivitamin Serum in people with Aesthetic, run by Erevna Innovations Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 45 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Skin Hydration From Baseline (time frame: Baseline to final follow-up (Week 10 for Group A; Week 16 for Group B)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07210190.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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