Post-Menopause Skin Rejuvenation Study (NCT07205744) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Post-Menopause Skin Rejuvenation Study
Canada50 participantsStarted 2025-08-14
Plain-language 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.
Who can participate
Age range
40 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the efficacy of HASBV and PLLA-SCA in improving skin-related clinical outcomes in the post-menopausal population.
. For subgroup analysis: either currently on stable-dose HRT for ≥ 6 months or not receiving any form of HRT for ≥6 months
Exclusion criteria
. 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:
. 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.