Aesthetic, Menopause, Post-menopause, Injectables, Biostimulator, Hyaluronic Acid
Conditions
Brief 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.
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)
Interventions
DEVICERestylane SkinBoosters Vital
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® 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.
Sponsors
Erevna Innovations Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. post-menopausal participants between the age of 40 and 65 years old; 3. 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. 4. 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. 5. Participant is willing and able to comply with procedures required in the protocol. 6. Participant must be in good health as per investigator's judgment based on medical history 7. For subgroup analysis: either currently on stable-dose HRT for ≥ 6 months or not receiving any form of HRT for ≥6 months
Exclusion criteria
1. Previous biostimulators 18 months prior to this study; 2. Previous SP-HA 18 months prior to this study; 3. Previous HA injectables 18 months prior to study in the facial and décolleté region; 4. Participant has an uncontrolled systemic disease. 5. 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 * 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 6. 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. 7. Participant has a history of an allergic reaction or significant sensitivity to constituents of the study medical device (or its excipients) including Vicryl 8. Participant has an tattoos, jewellery, or clothing which obscure the treatment area and cannot be removed. 9. Participant has an anticipated need for surgery or overnight hospitalization during the study. 10. 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). 11. Participant with known active COVID infection within 14 days of baseline treatment. 12. Participant is currently enrolled in another clinical study. 13. Participant is presenting with porphyria. 14. Participant presents with active disease, such as inflammation, infection or tumors, in or near the intended treatment sites. 15. Participant has a bleeding disorder or take thrombolytics or anticoagulants. 16. Participant has a need to take immunosuppressants. 17. Participant has undergone dental procedures including teeth cleaning withing 14 days prior to baseline treatment 18. Participant has undergone any vaccine administration withing the 14 days prior to treatment administration 19. Participant categorised as a heavy smoker, more than 12 cigarettes per day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the efficacy of HASBV and PLLA-SCA in improving skin-related clinical outcomes in the post-menopausal population. | Baseline to Week 26 | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the impact of HASBV and PLLA-SCA treatments on facial skin in the post-menopausal population using Objective Parameters | Baseline to Week 36 | Assess changes in skin parameters using the Courage+Khazaka electronic GmbH instrumentation |
| 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 | Baseline, Week 12-16, Week 28-36 | Assess changes in biological parameters in tissue samples from baseline |
| Evaluate the impact of HASBV and PLLA-SCA treatments on the décolleté skin in the post-menopausal population using: Objective Parameters | Baseline Week 36 | Changes in Skin parameters using the Courage+Khazaka electronic GmbH instrumentation |
| Evaluate participants satisfaction with the treatment regimen for the face and décolleté. | Week 4-6 to Week 36 | 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. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORAndreas Nikolis, MD, PhD
Erevna Innovations Inc.
Outcome results
None listed