Xeomin, Radiesse, and Belotero Facial/Neck Rejuvenational

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: Completed
• Conditions: Photoaging
• Intervention / Treatment: Drug: Radiesse, Xeomin, Belotero

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: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
FACE-Q Subject Satisfaction	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Global Assessment Investigator Scale	3 months

Collaborators and Investigators

• Sponsor: Main Line Center for Laser Surgery
• Collaborators: Merz North America, Inc.
• Investigators: Study Director: Kachiu Lee, MD, Main Line Center for Laser Surgery

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ACTUAL): March 1, 2022
• Study Completion (ACTUAL): July 1, 2022

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (ACTUAL): September 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; incobotulinumtoxinA
• Other Study ID 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