Recruiting

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Restylane SkinBoosters Vital

+ Sculptra Aesthetic
Device
Drug
Who is being recruted

Aesthetic
+3

+ Menopause
+ Post-menopause
From 40 to 65 Years
+31 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.
Study ContactLaura Raco, MSc
Last updated: October 3, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 14, 2025Actual 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 
Principal SponsorErevna Innovations Inc.
Study ContactLaura Raco, MSc
Last updated: October 3, 2025
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 40 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Aesthetic
Menopause
Post-menopause
Injectables
Biostimulator
Hyaluronic Acid
Criteria
8 inclusion criteria required to participate
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

Show More Criteria

23 exclusion criteria prevent from participating
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

Show More Criteria

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

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).
Secondary Objectives

Assess changes in skin parameters using the Courage+Khazaka electronic GmbH instrumentation

Assess changes in biological parameters in tissue samples from baseline

Changes in Skin parameters using the Courage+Khazaka electronic GmbH instrumentation

Proportion of Participants being at least satisfied ("satisfied", "very much satisfied", or "extremely satisfied") with treatment at all visits after baseline (Visit 2 to Visit 8),using the seven-point participant satisfaction with treatment questionnaire.

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
Recruiting
Erevna Innovations Inc.Montreal, CanadaSee the location
Recruiting
One Study Center