Post-Menopause Skin Rejuvenation Study

What this trial studies

The post-menopausal state is marked by a sharp decline in estrogen, leading to significant structural and functional changes in the skin, including collagen loss, dryness, thinning, and reduced elasticity. To address these concerns, aesthetic injectables products such as Sculptra® Aesthetic (poly-L-lactic-acid \[PLLA- SCA\]) and Restylane Skinboosters®\[HASBV\] (small-particle hyaluronic acid - SP-HA) can be used. PLLA-SCA stimulates collagen production via cellular activation (biostimulator), gradually improving dermal structure. HASBV enhances hydration, elasticity, and skin texture when injected under the skin.

Conditions in scope

• Aesthetic
• Menopause
• Post-menopause
• Injectables
• Biostimulator
• Hyaluronic Acid

Interventions

• Restylane SkinBoosters Vital (Device) — Restylane® Skinboosters™ Vital (HASBV) is manufactured by Galderma Laboratories. It is a sterile non-animal hyaluronic acid (20mg/mL) based gel that is supplied in a 1mL glass syringe. The syringed is packed with a 29G TW (thin-walled) needle. For this study,…
• Sculptra Aesthetic (Drug) — Sculptra® Aesthetic (PLLA-SCA) is manufactured by Galderma Laboratories. It is a sterile, lyophilized preparation of PLLA that is biocompatible and biodegradable. Each vial contains 367.5 mg of freeze-dried powder, including 150 mg of PLLA. Prior to injection, it will be…

Who can join

Women only · Ages 40 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee, prior to the initiation of any screening or study-specific procedures.
• post-menopausal participants between the age of 40 and 65 years old;
• Participants with a -menopausal status (at least 12 consecutive months of amenorrhea without other pathological or physiological causes).
• A clinical evaluation will be undertaken by a clinical professional to determine post-menopausal status.
• Participants with established clinical signs of skin aging including but not limited to: reduced skin elasticity, increased wrinkling, dryness, volume loss and/or contour deficits.
• Participant is willing and able to comply with procedures required in the protocol.
• Participant must be in good health as per investigator's judgment based on medical history
• For subgroup analysis: either currently on stable-dose HRT for ≥ 6 months or not receiving any form of HRT for ≥6 months

Exclusion criteria

• Previous biostimulators 18 months prior to this study;
• Previous SP-HA 18 months prior to this study;
• Previous HA injectables 18 months prior to study in the facial and décolleté region;
• Participant has an uncontrolled systemic disease.
• Participant presents with or has a history of any medical condition that may place the participant at an increased risk following exposure to hyaluronic acid or interfere with the study evaluation, including:
• Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
• History of facial nerve palsy
• Infection or dermatological condition at the treatment injection sites

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: PHASE4
• Start date: 2025-08-14
• Primary completion: 2026-08-28
• Last update posted: 2026-01-22
• First posted: 2025-10-03

Sponsor & contact

Lead sponsor: Erevna Innovations Inc. (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Evaluate the efficacy of HASBV and PLLA-SCA in improving skin-related clinical outcomes in the post-menopausal population. (Baseline to Week 26)
  Frequency of participants having at least "improved" (e.g., "improved", "much improved" or "very much improved") on the Global Aesthetics Improvement Scale (GAIS) of the face and décolleté regions, as graded by a blinded evaluator with two-dimensional and/or three-dimensional (2D and 3D) photography, at all visits (Canon EOS, VISIA, Canfield Scientific).

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.