Suspended

Post-Menopausal Skin Complaints Management in Women Aged 40-65

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What is being tested

Restylane SkinBoosters Vital

+ Sculptra Aesthetic

DeviceDrug
Who is being recruted

From 40 to 65 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorErevna Innovations Inc.
Last updated: January 23, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 14, 2025

Actual date on which the first participant was enrolled.

This study focuses on addressing skin concerns in post-menopausal women, specifically targeting those aged 40 to 65 with visible aging on their face or chest. It includes women who are using Hormone Replacement Therapy (HRT) and those who are not, aiming to explore different treatment effects based on their primary skin complaints, either hydration issues or skin laxity. The study is important as it seeks to improve skin appearance and quality in post-menopausal women, potentially enhancing their quality of life by finding effective treatments for these common skin aging problems. Participants are divided into two groups based on their main skin concern. Group A focuses on hydration issues and receives a treatment called HASBV first, followed by PLLA-SCA. Group B, which targets skin laxity, receives PLLA-SCA first, followed by HASBV. This approach helps researchers understand which treatment order is more effective for each type of skin complaint. The treatments are topical or injectable, and the study observes changes in skin appearance to determine the best approach for managing post-menopausal skin aging.

Official TitleManagement of Post-Menopausal Skin Complaints: An Open Label Study 
NCT07205744
Principal SponsorErevna Innovations Inc.
Last updated: January 23, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 40 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate
Participants must have a post-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.
Participant must be in good health as per investigator's judgment based on medical history.
Participant is willing and able to comply with procedures required in the protocol.
For subgroup analysis: either currently on stable-dose HRT for ≥ 6 months or not receiving any form of HRT for ≥6 months
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19 exclusion criteria prevent from participating
Previous SP-HA 18 months prior to this study.
Participant has a bleeding disorder or take thrombolytics or anticoagulants.
Participant has an uncontrolled systemic disease.
Participant has undergone any vaccine administration within the 14 days prior to treatment administration.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Erevna Innovations Inc.

Montreal, CanadaSee the location
SuspendedOne Study Center