NCT05039723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

September 1, 2021

Last Update Submit

July 6, 2022

Conditions

Photoaging

Outcome Measures

Primary Outcomes (1)

  • FACE-Q Subject Satisfaction

    3 months

Secondary Outcomes (1)

  • Global Assessment Investigator Scale

    3 months

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with Xeomin, Radiesse, and/or Belotero

Drug: Radiesse, Xeomin, Belotero

Interventions

Radiesse, Xeomin, BeloteroDRUG

Rejuvenation with Radiesse, Xeomin, Belotero

Treatment

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, 19003, United States

Location

MeSH Terms

Interventions

incobotulinumtoxinA

Study Officials

  • Kachiu Lee, MD

    Main Line Center for Laser Surgery

    STUDY DIRECTOR

  • Eric Bernstein, MD

    Main Line Center for Laser Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 10, 2021

Study Start

September 1, 2021

Primary Completion

March 1, 2022

Study Completion

July 1, 2022

Last Updated

July 7, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)