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ACTIVE NOT RECRUITING
NCT07205744
PHASE4

Post-Menopause Skin Rejuvenation Study

Sponsor: Erevna Innovations Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

40 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-08-14

Completion Date

2026-09-28

Last Updated

2026-01-22

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Erevna Innovations Inc.

Montreal, Quebec, Canada