AestheticPhase 4NCT07368686
Topical Multivitamin Serum for Skin Heath
A Phase 4 study testing Microneedeling with topical application of VAMP(TM) ADVANCED Topical Multivitamin Serum in people with Aesthetic, run by Erevna Innovations Inc. at 1 site in Canada.
Trial 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. 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(TM) ADVANCED 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
- 16 Mar 2026to 9 Sep 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
Who cannot join
- 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.
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- 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.
- 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.
- Known allergy to fish or seafood, including but not limited to salmon, due to the potential presence of PDRN derived from marine sources.
- History of cancer or previous radiation near or on the area to be treated.
- Heavy smokers, classified as smoking more than 12 cigarettes per day.
- 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.
- 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.
- 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.
- 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.
- Treatment with chemotherapy, immunosuppressive agents, systemic corticosteroids within 3 months before treatment (inhaled or ophthalmic corticosteroids are allowed).
- 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.
- 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.
- Pregnancy (confirmed by positive urine pregnancy test (UPT)/ serum pregnancy test), breast feeding or intends to become pregnant over the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Clinical Study Evaluating the Effects of a Topical Multivitamin Serum on Facial Skin Hydration and Biophysical Parameters Following Microneedling
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
- Being tested
- Microneedeling with topical application of VAMP(TM) ADVANCED Topical Multivitamin Serum
- Keywords
- Skin Heath, Topical, PDRN, Microneedeling, Skin Health
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(TM) ADVANCED 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Microneedeling with topical application of VAMP(TM) ADVANCED Topical Multivitamin Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to Week 10 (Group 1) and Week 16 (Group 2)
Secondary outcomes (7)
Safety and Tolerability of Treatment
Incidence and frequency of adverse events
Measured: Baseline to Week 10 (Group 1) and Week 16 (Group 2)
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 (Group 1) and Week 16 (Group 2)
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 (Group 1) and from Week 4 to Week 16 (Group 2)
Change in Transepidermal Water Loss (TEWL) From Baseline
Percentage change in TEWL from Baseline, measured using the Tewameter TM 21
Measured: Baseline to Week 10 (Group 1) and Week 16 (Group 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 Week 10 (Group 1) and Week 16 (Group 2)
Change in Skin Elasticity From Baseline
Percentage change in skin elasticity from Baseline, measured using the Cutometer Dual MPA 580.
Measured: Baseline to Week 10 (Group 1) and Week 16 (Group 2)
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 Week 10 (Group 1) and Week 16 (Group 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start16 Mar 2026
- Primary completion12 Aug 2026
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AestheticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Erevna Innovations Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Nikolis, MD, PhD, Principal investigator, Erevna Innovations Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368686
- Sponsor's protocol ID
- PRO-2025-VAMP-01
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study Evaluating the Effects of a Topical Multivitamin Serum on Facial Skin Hydration and Biophysical Parameters Following Microneedling
- ClinicalTrials.gov ID
- NCT07368686
- Acronym / sponsor ID
- PRO-2025-VAMP-01
- Conditions
- Aesthetic
- Keywords
- Skin Heath, Topical, PDRN, Microneedeling, Skin Health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Erevna Innovations Inc.University, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biweekly Microneedeling - Group 1 | Active comparator | Device: Microneedeling with topical application of VAMP(TM) ADVANCED Topical Multivitamin SerumParticipants 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 |
| Monthly Microneedeling - Group 2 | Active comparator | Device: Microneedeling with topical application of VAMP(TM) ADVANCED Topical Multivitamin SerumParticipants 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. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (35 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microneedeling with topical application of VAMP(TM) ADVANCED Topical Multivitamin SerumVAMP™ 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. | Device | Biweekly Microneedeling - Group 1, Monthly Microneedeling - Group 2 |
Primary outcome
Percentage Change in Skin Hydration
Time frame: Baseline to Week 10 (Group 1) and Week 16 (Group 2)
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).
7 secondary outcomes
Safety and Tolerability of Treatment
Time frame: Baseline to Week 10 (Group 1) and Week 16 (Group 2)
Global Aesthetic Improvement Scale (GAIS) Score Assessed by Blinded Evaluator
Time frame: Baseline to Week 10 (Group 1) and Week 16 (Group 2)
Participant Satisfaction With Treatment
Time frame: Week 2 to Week 10 (Group 1) and from Week 4 to Week 16 (Group 2)
Change in Transepidermal Water Loss (TEWL) From Baseline
Time frame: Baseline to Week 10 (Group 1) and Week 16 (Group 2)
Change in Skin Surface Biophysical Parameters From Baseline
Time frame: Baseline to Week 10 (Group 1) and Week 16 (Group 2)
Change in Skin Elasticity From Baseline
Time frame: Baseline to Week 10 (Group 1) and Week 16 (Group 2)
Change in VISIA® CR Facial Imaging Metrics
Time frame: Baseline to Week 10 (Group 1) and Week 16 (Group 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Nikolis, MD, PhD principal investigator
Erevna Innovations Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Microneedeling with topical application of VAMP(TM) ADVANCED 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 15 inclusion and 35 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 11 Sep 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?
Percentage Change in Skin Hydration (time frame: Baseline to Week 10 (Group 1) and Week 16 (Group 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.