Microneedling for Skin Heath

NCT07210190 | Recruiting Phase 4

• 1 other identifier: PRO-2025-VAMP-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Topical; Polydeoxyribonucleotide; Skin booster; Skin; Hydration

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (7)

• Change in Transepidermal Water Loss (TEWL) From Baseline

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

• Change in Skin Surface Biophysical Parameters From Baseline

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

• Change in Skin Elasticity From Baseline

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

• Participant Satisfaction With Treatment

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

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

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

Study Arms (2)

Group A - biweekly treatment schedule

ACTIVE COMPARATOR

Participants 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

Device: Microneedeling with topical application of VAMP™ Topical Multivitamin Serum

Group B - month treatment schedule

ACTIVE COMPARATOR

Participants 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

Device: Microneedeling with topical application of VAMP™ Topical Multivitamin Serum

Interventions

Microneedeling with topical application of VAMP™ Topical Multivitamin Serum DEVICE

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.

Group A - biweekly treatment schedule; Group B - month treatment schedule

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• \. Known allergy or intolerance to topical anesthetics or lidocaine. 3. History of hypersensitivity reactions such as anaphylaxis, angioedema, or other severe allergic responses.
• \. History of hypertrophic scarring, keloid formation, or post-inflammatory hyperpigmentation following cosmetic treatments.
• \. Tattoos, piercings, or skin bleaching agents in the treatment area that may interfere with assessments, as judged by the Investigator.
• \. Participants with known pigmentary instability or history of adverse response to microneedling.
• \. 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.
• \. Energy-based devices (laser, IPL, RF, ultrasound) in the last 6 months. 10. Microneedling, dermabrasion, mesotherapy, or chemical peels in the last 6 months.
• \. Use of topical corticosteroids, retinoids, or depigmenting agents in the treatment area within the past 4 weeks.
• \. Current use of immunosuppressive therapy, systemic corticosteroids, or chemotherapy within the last 3 months.
• \. History of systemic autoimmune, collagen vascular, or bleeding disorders (e.g., lupus, scleroderma, thrombocytopenia).
• \. Current pregnancy, positive urine pregnancy test at screening, breastfeeding, or intent to become pregnant during the study.
• \. Participation in another clinical study within the past 30 days or concurrent participation in another interventional trial.
• \. 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.
• \. Initiation of a weight loss program or GLP-1 agonist therapy within 30 days before baseline or planned during study period.
• \. Active skin conditions exacerbated by microneedling or transepidermal delivery, including chronic dermatitis or impaired barrier function.
• \. Current participation by study personnel, immediate family members, or employees of the Sponsor.

Sponsors & Collaborators

• Erevna Innovations Inc.: lead

Study Sites (1)

Erevna Innovations Inc.

Montreal, Quebec, H3Z 1C3, Canada

RECRUITING

Study Officials

• Andreas Nikolis, MD, PhD

  Erevna Innovations Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Raco

CONTACT

514-488-0163; lraco@vicpark.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: January 17, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)