NCT07205744

Post-Menopause Skin Rejuvenation Study

Management of Post-Menopausal Skin Complaints: An Open Label Study

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Erevna Innovations Inc. · Academic / Other
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a prospective, controlled, open-label study involving fifty (50) post-menopausal adult female participants between the age of 40 and 65, who are both utilizing and not utilizing Hormone Replacement Therapy (HRT) to control post-menopausal symptoms. All participants with facial or décolleté skin aging will be considered eligible for treatment following completion of the informed consent process and Baseline evaluation. Randomization (as primary participant complaint) will be undertaken to allocate participants to one of two groups: * Group A (Hydration as Primary Complaint): HASBV followed by PLLA-SCA (n = 25) * Group B (Laxity as Primary Complaint): PLLA-SCA followed by HASBV (n = 25)

Conditions

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

Interventions

Type	Name	Description
DEVICE	Restylane SkinBoosters Vital	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.
DRUG	Sculptra Aesthetic	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.

Timeline

• Start date: 2025-08-14
• Primary completion: 2026-08-28
• Completion: 2026-09-28
• First posted: 2025-10-03
• Last updated: 2026-01-22

Locations

1 site across 1 country: Canada