Topical Multivitamin Serum for Skin Heath

NCT07368686 | Recruiting Phase 4

• 1 other identifier: PRO-2025-VAMP-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Skin boosters are injectable and topical treatments designed to improve dermal quality and restore skin health. These products typically include hyaluronic acid formulations, biostimulatory agents, platelet-rich plasma (PRP), growth factors, and polynucleotides. Their growing use in aesthetic medicine is supported by their diverse mechanisms of action and routes of administration. One such category of interest includes polynucleotide-based therapies, most notably Polydeoxyribonucleotide (PDRN). Derived from the DNA of salmon or trout, PDRN exhibits dual regenerative and anti-inflammatory properties. Mechanistically, it promotes tissue repair by supplying nucleotides essential for DNA synthesis and activates adenosine A2A receptors, thereby enhancing angiogenesis and mitigating inflammation. Clinically, PDRN has been applied in aesthetic medicine for skin rejuvenation, where it improves elasticity, texture, and reduces fine lines, as well as in wound healing and scar remodeling, supporting its integration into advanced bioregenerative protocols. Among such agents, VAMP™ ADVANCED Topical Multivitamin Serum is formulated to improve hydration, elasticity, and overall skin radiance through a proprietary blend of amino acids, vitamins, and peptides. While preliminary data suggest potential benefits, robust peer-reviewed clinical studies remain limited. This study seeks to evaluate the efficacy of topical application of VAMP™ ADVANCED Topical Multivitamin Serum following microneedling in skin rejuvenation.

Conditions

Aesthetic

Keywords

Skin Heath; Topical; PDRN; Microneedeling; Skin Health

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Skin Hydration

  The percentage change in skin hydration from baseline to Visit 6 will be assessed to compare the effects of biweekly versus monthly administration of VAMP™ Advanced following microneedling treatment. Assessment will be made using the Corneometer CM 825 (Courage+Khazaka electronic GmbH).

  Baseline to Week 10 (Group 1) and Week 16 (Group 2)

Secondary Outcomes (7)

• Safety and Tolerability of Treatment

  Baseline to Week 10 (Group 1) and Week 16 (Group 2)

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

  Baseline to Week 10 (Group 1) and Week 16 (Group 2)

• Participant Satisfaction With Treatment

  Week 2 to Week 10 (Group 1) and from Week 4 to Week 16 (Group 2)

• Change in Transepidermal Water Loss (TEWL) From Baseline

  Baseline to Week 10 (Group 1) and Week 16 (Group 2)

• Change in Skin Surface Biophysical Parameters From Baseline

  Baseline to Week 10 (Group 1) and Week 16 (Group 2)

Study Arms (2)

Biweekly Microneedeling - Group 1

ACTIVE COMPARATOR

Participants randomized to Group 1 will undergo an initial microneedling session using a hyaluronic acid vehicle solution to prime the skin. Subsequently, participants will undergo three (3) additional microneedling sessions utilizing the VAMP™ Advanced Multivitamin Serum, administered on a biweekly basis (every two weeks). In total, participants will receive four (4) microneedling treatment sessions, followed by two (2) follow-up visits

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

Monthly Microneedeling - Group 2

ACTIVE COMPARATOR

Participants randomized to Group 2 will undergo an initial microneedling session using a hyaluronic acid vehicle solution to prime the skin. Subsequently, participants will undergo three (3) additional microneedling sessions utilizing the VAMP™ Advanced Multivitamin Serum, administered on a monthly basis (every four weeks). In total, participants will receive four (4) microneedling treatment sessions, followed by two (2) follow-up visits.

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

Interventions

Microneedeling with topical application of VAMP(TM) ADVANCED 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.

Biweekly Microneedeling - Group 1; Monthly Microneedeling - Group 2

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 or suspected allergy or hypersensitivity to any components of VAMP™ ADVANCED Topical Multivitamin Serum, including sodium hyaluronate, peptides, polynucleotides (e.g., PDRN), or excipients.
• Known allergy or intolerance to topical anesthetics or lidocaine.
• 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:
• 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.
• 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.

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

514-488-0613; 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: January 20, 2026
• First Posted: January 26, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)