Post-Menopause Skin Rejuvenation Study

NCT07205744 | Active Not Recruiting Phase 4

• 1 other identifier: GAL-2025-MENO-75
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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. Considering that hydration and laxity represent the primary aesthetic concerns in this patient population. Targeted treatment with SP-HA (HASBV) to improve hydration and PLLA-SCA to address laxity have been shown to produce significant clinical outcomes by directly addressing these key dermal deficiencies. This approach forms the basis of the current study.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of HASBV and PLLA-SCA in improving skin-related clinical outcomes in the post-menopausal population.

  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).

  Baseline to Week 26

Secondary Outcomes (4)

• Evaluate the impact of HASBV and PLLA-SCA treatments on facial skin in the post-menopausal population using Objective Parameters

  Baseline to Week 36

• Evaluate the impact of HASBV and PLLA-SCA treatments on facial skin in the post-menopausal population using Histological analysis of treated skin in a subset of consenting participants

  Baseline, Week 12-16, Week 28-36

• Evaluate the impact of HASBV and PLLA-SCA treatments on the décolleté skin in the post-menopausal population using: Objective Parameters

  Baseline Week 36

• Evaluate participants satisfaction with the treatment regimen for the face and décolleté.

  Week 4-6 to Week 36

Other Outcomes (3)

• Subgroup Analysis of Treatment Response Between HRT-Treated and Non-HRT-Treated Post-Menopausal Participants

  Baseline to Week 36

• Change in Facial and Décolleté Skin Thickness using high frequency ultrasonography

  Baseline to Week 36

• Incidence and Severity of Adverse Events (AEs)

  Baseline to Week 36

Study Arms (2)

Primary Complaint: Lack of skin hydration

OTHER

Participants presenting with a primary complaint of lack of skin hydration will be administer primarily with Restylane SkinBoosters Vital followed by Sulptra Aesthetic

Device: Restylane SkinBoosters Vital

Primary Complaint: Loss of skin elasticity

OTHER

Participants presenting with a primary complaint of lack of skin elasticity will be administer primarily with Sculptra Aesthetic followed by Restylane SkinBoosters Vital

Drug: Sculptra Aesthetic

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, commercial products will be used. The study products are for single use only.

Primary Complaint: Lack of skin hydration

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 reconstituted with sterile water for injection (SWFI) and lidocaine hydrochloride (2%). For this study, commercial products will be used. The study products are for single use only.

Primary Complaint: Loss of skin elasticity

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Marked dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or excessively photodamaged skin
• Participant has a history of clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive the study medical device.
• Participant has a history of an allergic reaction or significant sensitivity to constituents of the study medical device (or its excipients) including Vicryl
• Participant has an tattoos, jewellery, or clothing which obscure the treatment area and cannot be removed.
• Participant has an anticipated need for surgery or overnight hospitalization during the study.
• Participant has a history of surgical procedures in intended treatment areas, including any lifting procedure (e.g., facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery, neck lift).
• Participant with known active COVID infection within 14 days of baseline treatment.

Sponsors & Collaborators

• Erevna Innovations Inc.: lead

Study Sites (1)

Erevna Innovations Inc.

Montreal, Quebec, H3Z 1C3, Canada

Location

Study Officials

• Andreas Nikolis, MD, PhD

  Erevna Innovations Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 3, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): September 28, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)