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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will compare two injectable treatments for reducing the appearance of superficial, vertical perioral lines.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Response to Therapy- Subject

Severity grading- Evaluator

VISIA complexion analysis

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Maas ClinicLead Sponsor

2 Previous Clinical Trials

105 Total Patients Enrolled

Corey S. Maas, M.D.Principal InvestigatorThe Maas Clinic

Media Library

Belotero Balance (Dermal Filler) Clinical Trial Eligibility Overview. Trial Name: NCT02818556 — Phase 4

Perioral Wrinkles Research Study Groups: Restylane Right, Belotero Left, Restylane Left, Belotero Right

Perioral Wrinkles Clinical Trial 2023: Belotero Balance Highlights & Side Effects. Trial Name: NCT02818556 — Phase 4

Belotero Balance (Dermal Filler) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02818556 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How perilous might the outcomes of this treatment be for patients?

"Given this is a Phase 4 trial, implying that the treatment has been approved by regulatory authorities, Power judged its safety at 3 on our scale."

Answered by AI

How many participants are taking part in this research initiative?

"This clinical trial is not presently welcoming new participants. The study, which was initially posted on June 1st 2016 and last updated on July 28th 2016, has reached its recruitment limit at this time. If you are searching for other trials, there are currently one active investigation with perioral rhytids that is actively recruiting patients as well as 16 studies related to the same treatment in search of individuals willing to participate."

Answered by AI

Are there any openings available in this trial for prospective participants?

"Unfortunately, this trial has concluded recruitment and can no longer accept participants. It was initially posted on June 1st 2016 but the last edit occured at the end of June in the same year. On a more positive note, there are 17 other studies that may be suitable for those seeking treatment for perioral rhytids; with one study still actively recruiting patients."

Answered by AI

Are there any other explorations that have been done regarding this particular therapeutic approach?

"Currently, 16 clinical investigations related to this treatment regimen are ongoing. Of these trials, 4 have progressed to phase 3. Morgantown in West virginia houses a large volume of the studies; however 31 different sites throughout America are running tests pertaining to this medication."

Answered by AI

For what kind of condition is this medication typically prescribed?

"This treatment is well known for its efficacy in treating skin irritation, but can also be beneficial to individuals struggling with osteoarthritis (OA), dermabrasion and other epidermal conditions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Study Comparing Restylane® Silk and Belotero Balance® for the Treatment of Superficial, Vertical Perioral Lines

Corey S. Maas, M.D. 2016. "A Clinical Study Comparing Restylane® Silk and Belotero Balance® for the Treatment of Superficial, Vertical Perioral Lines". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02818556.