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 range40 Years – 65 Years
SexFEMALE
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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
✓. 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;
What they're measuring
1
Evaluate the efficacy of HASBV and PLLA-SCA in improving skin-related clinical outcomes in the post-menopausal population.
✕. 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.