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AestheticPhase 4NCT07383766

Aesthetic Improvement of Facial Rhytids Using Injectables

A Phase 4 study testing Revanesse® Renew™+ 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

Revanesse® Renew™+ (Prollenium Medical Technologies Inc.) is a non-crosslinked HA skin booster that combines low- and high-molecular-weight HA at a concentration of 14 mg/mL in a sterile aqueous gel for intradermal injection7. Read more about this study

Who is it for?
Ages 30 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Aesthetic
What is being tested?
Revanesse® Renew™+
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteCanada
Study dates
14 Mar 2026to 4 Aug 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 30 to 75 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 30 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 Revanesse® Renew™+
  • 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.
  • Previous cosmetic or dermatologic procedures in the treatment area within the following time frames:
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  • 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.
  • Current participation by study personnel, immediate family members, or employees of the Sponsor.
  • 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.
  • 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.

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 Skin Boosting Injectable on the Aesthetic Improvement of Facial Rhytids

Revanesse® Renew™+ (Prollenium Medical Technologies Inc.) is a non-crosslinked HA skin booster that combines low- and high-molecular-weight HA at a concentration of 14 mg/mL in a sterile aqueous gel for intradermal injection7. This dual-weight formulation provides both rapid hydration and sustained moisture retention, improving dermal suppleness and promoting subtle textural refinement through physiologic hydration rather than volumization.

The present study is designed to compare biweekly and monthly treatment schedules of Revanesse® Renew™+, assessing clinical efficacy, objective biophysical markers, and participant-reported outcomes to inform evidence-based treatment protocols in aesthetic medicine.

Conditions
Aesthetic
Being tested
Revanesse® Renew™+
Keywords
Hydration, Skin Heath, Skin Booster, Hyaluronic Acid, Injectable

What participants receive

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

  • Revanesse® Renew™+Device

    Revanesse® Renew™+, a sterile, colorless, odorless, transparent, aqueous gel of synthetic origin supplied in pre-filled disposable syringes. Revanesse® Renew™+ is manufactured by Prollenium Medical Technologies Inc. It consists of both low- and high-molecular-weight hyaluronic acid (HA) at a concentration of 14 mg/mL. The product is supplied in pre-filled disposable syringes, each containing 1.2 mL of ready-to-use gel intended for single use.

    The product does not require reconstitution or dilution prior to injection and is administered directly into the superficial to mid-dermal plane according to the manufacturer's instructions.

Study groups in NCT07383766
Study groupRoleWhat they receive
Group A: Biweekly TreatmentActive comparatorParticipants randomized to Group 1 : Biweekly Treatment, will undergo three treatments with Revanesse (R) Renew(TM)+ spaced 2 weeks apart.
Receives: Device: Revanesse® Renew™+
Group B: Monthly TreatmentActive comparatorParticipants randomized to Group 2: Monthly Treatment, will undergo three treatments with Revanesse (R) Renew(TM)+ spaced 4 weeks apart.
Receives: Device: Revanesse® Renew™+

What is being measured

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

  1. Global Aesthetic Improvement Scale (GAIS) Score Assessed by Blinded Evaluat

    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 12 (Group 1) and Week 16 (Group 2)]

Secondary outcomes (8)

  1. Safety and Tolerability of Treatment - Patient reported

    Incidence and frequency of adverse events

    Measured: Baseline to Week 12 (Group 1) and Week 16 (Group 2)]

  2. Safety and Tolerability of Treatment - Physician recoded

    Incidence and frequency of adverse events

    Measured: Baseline to Week 12 (Group 1) and Week 16 (Group 2)]

  3. 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 Proportion of participants who report being at least "satisfied" (satisfied, very much satisfied, or extremely satisfied) on a seven-point participant satisfaction scale 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: Week 2 to Week 12 (Group 1) and Week 4 to Week 16 (Group 2)

  4. Percentage Change in Skin Hydration

    The percentage change in skin hydration from baseline to Visit 4,5,6 will be assessed to compare the effects of biweekly versus monthly administration of Revanesse® Renew™+ treatment. Assessment will be made using the Corneometer CM 825 (Courage+Khazaka electronic GmbH).

    Measured: Baseline to Week 12 (Group 1) and Week 16 (Group 2)

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

    Percentage change in TEWL from Baseline to Visit 4,5,6, measured using the Tewameter TM 21.

    Measured: Baseline to Week 12 (Group 1) and Week 16 (Group 2)

  6. 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) from baseline to Visit 4,5,6, measured via the VisioScan

    Measured: Baseline to Week 12 (Group 1) and Week 16 (Group 2)

  7. Change in Skin Elasticity From Baseline

    Percentage change in skin elasticity from baseline to Visit 4,5,6, measured using the Cutometer Dual MPA 580

    Measured: Baseline to Week 12 (Group 1) and Week 16 (Group 2)

  8. 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 12 (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.

  1. First posted3 Feb 2026
  2. Study start14 Mar 2026
  3. Primary completion4 Jun 2026
  4. Study completion4 Aug 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
Single blind
Who is masked
Outcomes assessor
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07383766
Sponsor's protocol ID
EINN-2025-PRENEW-03
Status last verified
Aug 2026
First submitted
26 Jan 2026
Last updated
5 Aug 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 Revanesse® Renew™+ 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 31 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 5 Aug 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?

Global Aesthetic Improvement Scale (GAIS) Score Assessed by Blinded Evaluat (time frame: Baseline to Week 12 (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?

On the ClinicalTrials.gov record for NCT07383766.

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 5 Aug 2026.

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