What side effects are associated with this type of intervention?

Common side effects of hyaluronic acid fillers like Restylane® Silk and Belotero Balance® for treating perioral wrinkles include temporary redness, swelling, pain, bruising, and tenderness at the injection site. Less frequently, patients may experience lumps or nodules, infection, and vascular occlusion, which can lead to tissue necrosis. These side effects are typically mild and self-resolving, but it is important to discuss potential risks with a healthcare provider.

What prior FDA approvals exist?

Hyaluronic acid fillers, such as Restylane® Silk and Belotero Balance®, have received FDA approval for the treatment of facial wrinkles, including perioral lines. These fillers work by adding volume to the skin, thereby reducing the appearance of wrinkles. Restylane® Silk is specifically designed for lip augmentation and the smoothing of wrinkles around the mouth, while Belotero Balance® is used for the correction of moderate-to-severe facial wrinkles and folds. Both products are part of a broader category of hyaluronic acid-based dermal fillers that have been widely approved and utilized for facial rejuvenation.

What other types of research exist?

Promising alternatives to Restylane® Silk and Belotero Balance® for perioral wrinkles include: 1) Calcium Hydroxylapatite (Radiesse), which stimulates collagen production and has shown efficacy in treating facial wrinkles and folds. 2) Poly-L-lactic Acid (Sculptra), which acts as a scaffold for collagen formation and is effective for volume restoration and wrinkle reduction. Both options offer longer-lasting results compared to traditional hyaluronic acid fillers.

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Dermal Filler

Restylane Silk vs Belotero Balance for Perioral Wrinkles

Phase 4

Waitlist Available

Led By Corey S. Maas, M.D.

Research Sponsored by The Maas Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is planning to undergo Restylane® Silk and Belotero Balance® injections

For female patient of childbearing potential, must have had a regular menstrual cycle prior to study entry and is willing to use an acceptable form of birth control during the entire course of the study. Acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplanit®, Depo-Provena®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the patient become sexually active. All systemic birth control measures must be in consistent use at least 30 days prior to study participation

Must not have

A patient with any uncontrolled systemic disease. A potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study

A patient using any topical (prescription or over the counter) medicated creams, lotions, gels, balms, powders, etc. on the treatment areas during the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

All Individual Drugs Already Approved

Drug Has Already Been Approved

Summary

This trial involves using two types of facial fillers to treat wrinkles around the mouth. Participants will receive injections of these fillers on different sides of their faces. The fillers work by adding volume under the skin, which helps to smooth out wrinkles and make the skin look younger.

Who is the study for?

This trial is for adults over 18 with moderate to severe vertical perioral lines who haven't had dermal fillers or botulinum toxin in the target area recently. Participants must be in good health, not smoke, avoid certain skin treatments and products during the study, and use birth control if applicable.

What is being tested?

The study compares Restylane® Silk and Belotero Balance® for treating wrinkles around the mouth. Each participant receives both treatments on different sides of their face in a single session, followed by several check-ups over six months.

What are the potential side effects?

Potential side effects may include reactions at injection sites such as redness, swelling, pain, bruising or itching. There's also a risk of more serious side effects like allergic reactions or lumps/bumps formation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I plan to get Restylane Silk and Belotero Balance injections.

Select...

I am a woman who can have children, have regular periods, and will use birth control during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My other health conditions are under control and not affecting my treatment.

Select...

I am not using any medicated skin products on the treatment areas.

Select...

I haven't had certain skin treatments or taken steroids for the last 6 months.

Select...

I have had dermal filler treatment around my mouth in the last year.

Select...

I haven't used any tretinoin products on my mouth area in the last 12 weeks.

Select...

I have received botulinum toxin treatment around my mouth in the last 6 months.

Select...

I haven't used experimental drugs or had skin peels near my mouth in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Response to therapy as evaluated by investigator using 5-point Merz® Scale

Secondary study objectives

Response to Therapy- Subject

Severity grading- Evaluator

VISIA complexion analysis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Restylane Right, Belotero LeftExperimental Treatment2 Interventions

Patients will receive one treatment with Restylane® Silk (right side of the face) and one treatment of Belotero Balance® (left side)

Group II: Restylane Left, Belotero RightExperimental Treatment2 Interventions

Patients will receive one treatment with Restylane® Silk (left side of the face) and one treatment of Belotero Balance® (right side)

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Hyaluronic acid fillers, such as Restylane® Silk and Belotero Balance®, work by adding volume to the skin, which helps to smooth out wrinkles and fine lines. This is particularly important for perioral wrinkles, which are often caused by the loss of skin elasticity and volume due to aging. By injecting hyaluronic acid into the affected areas, the skin is plumped up, reducing the appearance of wrinkles and providing a more youthful look. Additionally, hyaluronic acid attracts water, which further helps to hydrate and maintain skin volume. This mechanism is crucial for patients with perioral wrinkles as it directly addresses the underlying issue of volume loss and skin hydration, leading to more effective and longer-lasting results.

Efficacy and Safety of Centella Asiatica (L.) Urb. on Wrinkles: A Systematic Review of Published Data and Network Meta-Analysis.A single-center clinical trial to evaluate the efficacy of a tripeptide/hexapeptide antiaging regimen.A study to determine the efficacy of combination LED light therapy (633 nm and 830 nm) in facial skin rejuvenation.