Xeomin, Radiesse, and Belotero Facial/Neck Rejuvenational

July 6, 2022 updated by: Eric Bernstein, MD, Main Line Center for Laser Surgery

Combination Treatment With Xeomin, Radiesse, and Belotero for Improvement in Photoaging and Skin Quality

The purpose of this study is to determine the improvement in signs of photoaging and subject satisfaction after combination, global facial and/or neck treatment with IncobotulinumA (Xeomin), HA (Belotero) and/or calcium hydroxyapatite (Radiesse+, Radiesse Classic). All products will be used on-label FDA-cleared indications.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Facial and neck aging is multifactorial, resulting from changes in anatomical aspects combined with changes in the skin integrity. The 5 key signs of photoaging will be evaluated both objectively and subjectively including: fine lines and wrinkles, enlarged pores, sagging skin, pigmentation and redness/flushing. These aspects of the aging face are often bothersome to patients who seek aesthetic treatments for correction.

Injectables, including IncobutolinumtoxinA, hyaluronic acid (HA), and calcium hydroxyapatite, have grown in popularity over the past decade due to their safety profiles, favorable results, and longevity. IncobutolinumtoxinA allows for correction of rhytides, while HA and calcium hydroxyapatite allow for lifting, contouring, and overall re-volumization. Further, calcium hydroxyapatite effectively restores volume and can improve skin texture through its biostimulatory effects, which have been well studied in the literature. Through inducing collagen formation in the skin, calcium hydroxyapatite can also improve skin quality and thickness. In contrast to volumization effects, the overall improvement in skin quality has not been as well studied. Further, it has been observed by patients and physicians that global treatment with toxins and fillers can produce a better result in skin texture than each agent on its own.

This study will consist of one treatment visit for global facial treatment using toxin and fillers (Xeomin, Radiesse+, Radiesse Classic, Belotero Balance) to enhance signs of facial photoaging and appearance.

This clinical investigation is a prospective study consisting of a screening/treatment visit and 3 follow-up visits. A total of 20 patients will be recruited. Following informed consent and screening, each eligible subject will be photographed with the Canfield Visia system. They will be treated at Baseline Visit (Day 0) with Xeomin, Belotero Balance, Radiesse+, and/or Radiesse Classic. Determination of which facial and/or neck areas to be treated will be made after assessment by the investigator and discussion with the patient. All products will be used on-label in their FDA-cleared manner. Post-treatment, patients will be instructed to apply ice to all areas for 3-5 minutes immediately afterwards.

The patient will return at post-treatment months 1 and 3 for GAIS and FACE-Q Subject Satisfaction and photography with the Canfield Visia system. A blinded independent evaluator will evaluate the baseline and post-treatment photographs on a 5-point scale for fine lines and wrinkles, enlarged pores, redness, flushing, pigmentation, and sagging skin.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Ardmore, Pennsylvania, United States, 19003
        • Main Line Center for Laser Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >21
  • No toxin treatment in last 3 months
  • No filler treatment in last 3 months
  • Glogau facing aging scale >=1

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Allergy to prior Radiesse, Belotero, Xeomin products
  • History of any facial nerve palsy (ie. Bell's Palsy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Treatment
Treatment with Xeomin, Radiesse, and/or Belotero
Drug: Radiesse, Xeomin, Belotero
Rejuvenation with Radiesse, Xeomin, Belotero

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
FACE-Q Subject Satisfaction
Time Frame: 3 months
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Global Assessment Investigator Scale
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Main Line Center for Laser Surgery

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merz North America, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kachiu Lee, MD, Main Line Center for Laser Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Merz IIT7600

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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