Actively Recruiting

Phase 4
Age: 30Years - 75Years
All Genders
Healthy Volunteers
NCT07383766

Aesthetic Improvement of Facial Rhytids Using Injectables

Led by Erevna Innovations Inc. · Updated on 2026-02-05

14

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Aesthetic Improvement of Facial Rhytids Using Injectables

Who Can Participate

Age: 30Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand study information and give written consent
  • Interested in improving skin quality
  • Immune-competent adult aged 30 years or older
  • Intends to undergo treatment to improve facial skin appearance
  • Willing to comply with pre-visit instructions, including shaving facial area if male
  • Women of childbearing potential must use effective birth control during the study and take pregnancy tests at baseline and before treatment
  • Negative pregnancy test at baseline for women of childbearing potential
  • Stable lifestyle and skincare routine for at least 4 weeks prior to study
Not Eligible

You will not qualify if you...

  • Allergy or hypersensitivity to Revanesse4 Renew�2B+ components
  • Allergy or intolerance to topical anesthetics or lidocaine
  • History of severe allergic reactions such as anaphylaxis or angioedema
  • History of hypertrophic scarring, keloids, or post-inflammatory hyperpigmentation after cosmetic treatments
  • Tattoos, piercings, or skin bleaching in the treatment area that interfere with assessments
  • Cosmetic or dermatologic treatments in the treatment area within specified timeframes (e.g., hyaluronic acid fillers within 12 months, energy-based devices within 6 months)
  • Use of topical corticosteroids, retinoids, or depigmenting agents in the treatment area within 4 weeks
  • Current use of immunosuppressive therapy, systemic corticosteroids, or chemotherapy within 3 months
  • History of autoimmune, collagen vascular, or bleeding disorders
  • Pregnancy, breastfeeding, or intent to become pregnant during the study
  • Participation in another clinical study within 30 days or concurrent interventional trials
  • Conditions interfering with informed consent or study compliance
  • Recent weight loss programs or GLP-1 agonist therapy within 30 days
  • Study personnel or immediate family participation
  • History of cancer or radiation near treatment area
  • Heavy smoking (more than 12 cigarettes per day)
  • Diseases or lesions near treatment area, including infections, psoriasis, eczema, cancerous or precancerous conditions, severe skin laxity, advanced photoaged skin, or other conditions interfering with safety or effectiveness
  • Use of medications prolonging bleeding times within 14 days prior to injection except certain allowed exceptions
  • Use of hormonal therapy unless stable for 3 months prior and no planned changes during study
  • Pregnancy confirmed by positive pregnancy test, breastfeeding, or intent to become pregnant during study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Erevna Innovations Inc.

Montreal, Quebec, Canada, H3Z 1C3

Actively Recruiting

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Research Team

L

Laura Raco, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Aesthetic Improvement of Facial Rhytids Using Injectables | DecenTrialz