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AestheticPhase 4NCT07205744

Post-Menopause Skin Rejuvenation Study

A Phase 4 study testing Restylane SkinBoosters Vital and Sculptra Aesthetic in people with Aesthetic and Menopause, run by Erevna Innovations Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Aesthetic, Menopause, Post-menopause
What is being tested?
Restylane SkinBoosters Vital and Sculptra Aesthetic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteCanada
Study dates
14 Aug 2025to 28 Sep 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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.
  • Participant is currently enrolled in another clinical study.
  • Participant is presenting with porphyria.
  • Participant presents with active disease, such as inflammation, infection or tumors, in or near the intended treatment sites.
  • Participant has a bleeding disorder or take thrombolytics or anticoagulants.
  • Participant has a need to take immunosuppressants.
  • Participant has undergone dental procedures including teeth cleaning withing 14 days prior to baseline treatment
  • Participant has undergone any vaccine administration withing the 14 days prior to treatment administration
  • Participant categorised as a heavy smoker, more than 12 cigarettes per day

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Erevna Innovations Inc.

    Montreal, Quebec, H3Z 1C3

Other trials in Canada

About this study

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

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.

Read the 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)
Being tested
Restylane SkinBoosters Vital, Sculptra Aesthetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Restylane SkinBoosters VitalDevice

    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.

  • Sculptra AestheticDrug

    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.

Study groups in NCT07205744
Study groupRoleWhat they receive
Primary Complaint: Lack of skin hydrationOtherParticipants presenting with a primary complaint of lack of skin hydration will be administer primarily with Restylane SkinBoosters Vital followed by Sulptra Aesthetic
Receives: Device: Restylane SkinBoosters Vital
Primary Complaint: Loss of skin elasticityOtherParticipants presenting with a primary complaint of lack of skin elasticity will be administer primarily with Sculptra Aesthetic followed by Restylane SkinBoosters Vital
Receives: Drug: Sculptra Aesthetic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline to Week 26

Secondary outcomes (4)

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

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

    Measured: Baseline to Week 36

  2. 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

    Assess changes in biological parameters in tissue samples from baseline

    Measured: Baseline, Week 12-16, Week 28-36

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

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

    Measured: Baseline Week 36

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

    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.

    Measured: Week 4-6 to Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2025
  2. Study start14 Aug 2025
  3. Primary completion13 Jul 2026
  4. Study completion28 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07205744
Sponsor's protocol ID
GAL-2025-MENO-75
Status last verified
Oct 2026
First submitted
18 Sep 2025
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Restylane SkinBoosters Vital and Sculptra Aesthetic in people with Aesthetic and Menopause, run by Erevna Innovations Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the efficacy of HASBV and PLLA-SCA in improving skin-related clinical outcomes in the post-menopausal population. (time frame: Baseline to Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07205744.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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