Sculptra + Restylane for Post-Menopausal Skin Concerns
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how two injectable treatments might improve skin concerns for post-menopausal women. Researchers are testing Sculptra Aesthetic and Restylane SkinBoosters to address issues like dry skin and loss of elasticity. Participants with noticeable signs of skin aging, such as dryness or wrinkles, who have been post-menopausal for at least a year may be suitable candidates. The study evaluates each treatment based on whether the primary concern is hydration or elasticity. As a Phase 4 trial, these treatments are already FDA-approved and proven effective, offering participants a chance to benefit from established therapies.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are on hormone replacement therapy (HRT), you must have been on a stable dose for at least 6 months or not receiving any form of HRT for at least 6 months.
What is the safety track record for these treatments?
Research has shown that Restylane SkinBoosters Vital and Sculptra Aesthetic are generally safe. Studies have found that Restylane SkinBoosters Vital, which improves skin moisture and flexibility, may cause mild side effects like redness, swelling, and minor bruising at the injection site. These effects are usually short-lived and resolve on their own.
For Sculptra Aesthetic, research indicates it offers a long-lasting cosmetic effect by boosting collagen production. This treatment is usually well-tolerated, though some people might experience temporary redness, swelling, or discomfort at the injection site.
Both treatments have received FDA approval for other uses, supporting their safety. This trial is in Phase 4, indicating the treatments have already passed earlier safety tests in people.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments because they combine the benefits of both Restylane SkinBoosters Vital and Sculptra Aesthetic to tackle post-menopausal skin concerns in a unique way. Unlike other treatments, which typically target either hydration or elasticity separately, this approach addresses both by first hydrating the skin with Restylane and then stimulating collagen production with Sculptra. This dual-action method could potentially offer more comprehensive and longer-lasting improvements in skin quality, making it stand out from existing options like topical creams or single-action fillers.
What evidence suggests that this trial's treatments could be effective for post-menopausal skin concerns?
Studies have shown that Restylane SkinBoosters Vital significantly improves skin hydration. This product uses hyaluronic acid, known for its ability to deeply hydrate and enhance skin quality over time. Clinical evidence supports its effectiveness in making the skin brighter, smoother, and more elastic. In this trial, participants with a primary complaint of lack of skin hydration will first receive Restylane SkinBoosters Vital, followed by Sculptra Aesthetic.
Research shows that Sculptra Aesthetic effectively increases collagen production, improving skin structure and firmness over time. It is particularly helpful for reducing skin looseness and restoring elasticity in post-menopausal women. Participants with a primary complaint of loss of skin elasticity in this trial will first receive Sculptra Aesthetic, followed by Restylane SkinBoosters Vital. Together, these treatments address important skin concerns like hydration and elasticity, making them promising options for improving post-menopausal skin.36789Who Is on the Research Team?
Andreas Nikolis, MD, PhD
Principal Investigator
Erevna Innovations Inc.
Are You a Good Fit for This Trial?
This trial is for post-menopausal individuals experiencing skin changes such as collagen loss, dryness, thinning, and reduced elasticity. Participants should be interested in cosmetic enhancement through injections. Specific eligibility criteria are not provided but typically include being in good health with no contraindications to the treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive HASBV and PLLA-SCA treatments based on primary skin complaint (hydration or laxity)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue to be monitored for long-term effects and satisfaction
What Are the Treatments Tested in This Trial?
Interventions
- Restylane SkinBoosters Vital
- Sculptra Aesthetic
Find a Clinic Near You
Who Is Running the Clinical Trial?
Erevna Innovations Inc.
Lead Sponsor