Aesthetic Improvement of Facial Rhytids Using Injectables

NCT07383766 | Recruiting Phase 4

• 1 other identifier: EINN-2025-PRENEW-03
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Hydration; Skin Heath; Skin Booster; Hyaluronic Acid; Injectable

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (8)

• Safety and Tolerability of Treatment - Patient reported

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

• Safety and Tolerability of Treatment - Physician recoded

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

• Participant Satisfaction With Treatment

  Week 2 to Week 12 (Group 1) and Week 4 to Week 16 (Group 2)

• Percentage Change in Skin Hydration

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

• Change in Transepidermal Water Loss (TEWL) From Baseline

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

Study Arms (2)

Group A: Biweekly Treatment

ACTIVE COMPARATOR

Participants randomized to Group 1 : Biweekly Treatment, will undergo three treatments with Revanesse (R) Renew(TM)+ spaced 2 weeks apart.

Device: Revanesse® Renew™+

Group B: Monthly Treatment

ACTIVE COMPARATOR

Participants randomized to Group 2: Monthly Treatment, will undergo three treatments with Revanesse (R) Renew(TM)+ spaced 4 weeks apart.

Device: Revanesse® Renew™+

Interventions

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.

Group A: Biweekly Treatment; Group B: Monthly Treatment

Eligibility Criteria

• Age: 30 Years - 75 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 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.
• 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 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:
• 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.

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, MSc

CONTACT

514-488-0163; lraco@vicpark.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): March 25, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)