Xeomin, Radiesse, and Belotero Facial/Neck Rejuvenational
Primary Purpose
Photoaging
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Radiesse, Xeomin, Belotero
Sponsored by
About this trial
This is an interventional treatment trial for Photoaging
Eligibility Criteria
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)
Sites / Locations
- Main Line Center for Laser Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Treatment with Xeomin, Radiesse, and/or Belotero
Outcomes
Primary Outcome Measures
FACE-Q Subject Satisfaction
Secondary Outcome Measures
Global Assessment Investigator Scale
Full Information
NCT ID
NCT05039723
First Posted
September 1, 2021
Last Updated
July 6, 2022
Sponsor
Main Line Center for Laser Surgery
Collaborators
Merz North America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05039723
Brief Title
Xeomin, Radiesse, and Belotero Facial/Neck Rejuvenational
Official Title
Combination Treatment With Xeomin, Radiesse, and Belotero for Improvement in Photoaging and Skin Quality
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Main Line Center for Laser Surgery
Collaborators
Merz North America, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Photoaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment with Xeomin, Radiesse, and/or Belotero
Intervention Type
Drug
Intervention Name(s)
Radiesse, Xeomin, Belotero
Intervention Description
Rejuvenation with Radiesse, Xeomin, Belotero
Primary Outcome Measure Information:
Title
FACE-Q Subject Satisfaction
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Global Assessment Investigator Scale
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kachiu Lee, MD
Organizational Affiliation
Main Line Center for Laser Surgery
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eric Bernstein, MD
Organizational Affiliation
Main Line Center for Laser Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Main Line Center for Laser Surgery
City
Ardmore
State/Province
Pennsylvania
ZIP/Postal Code
19003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Xeomin, Radiesse, and Belotero Facial/Neck Rejuvenational
We'll reach out to this number within 24 hrs