PhotoagingPhase 4NCT05039723
Xeomin, Radiesse, and Belotero Facial/Neck Rejuvenational
A Phase 4 study testing Radiesse, Xeomin, Belotero in people with Photoaging, run by Main Line Center for Laser Surgery at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Photoaging
- What is being tested?
- Radiesse, Xeomin, Belotero
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 1 Jul 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >21
- No toxin treatment in last 3 months
- No filler treatment in last 3 months
- Glogau facing aging scale >=1
Who cannot join
- Pregnancy
- Breastfeeding
- Allergy to prior Radiesse, Belotero, Xeomin products
- History of any facial nerve palsy (ie. Bell's Palsy)
Trial locations and contacts
1 site in 1 country.
United States1 site
Main Line Center for Laser Surgery
Ardmore, Pennsylvania, 19003
About this study
Official title: 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.
Read the 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.
- Conditions
- Photoaging
- Being tested
- Radiesse, Xeomin, Belotero
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiesse, Xeomin, BeloteroDrug
Rejuvenation with Radiesse, Xeomin, Belotero
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with Xeomin, Radiesse, and/or Belotero Receives: Drug: Radiesse, Xeomin, Belotero |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACE-Q Subject Satisfaction
Measured: 3 months
Secondary outcomes (1)
Global Assessment Investigator Scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 Sep 2021
- Primary completion1 Mar 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotoagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Main Line Center for Laser Surgery
- Sponsor type
- University, hospital or other
- Collaborators
- Merz North America, Inc.
- Responsible party
- Principal investigator, Eric Bernstein, MD, Main Line Center for Laser Surgery
- Investigators
- Kachiu Lee, MD, Study director, Main Line Center for Laser SurgeryEric Bernstein, MD, Principal investigator, Main Line Center for Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039723
- Sponsor's protocol ID
- Merz IIT7600
- Status last verified
- Jul 2022
- First submitted
- 1 Sep 2021
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Treatment With Xeomin, Radiesse, and Belotero for Improvement in Photoaging and Skin Quality
- ClinicalTrials.gov ID
- NCT05039723
- Acronym / sponsor ID
- Merz IIT7600
- Conditions
- Photoaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Main Line Center for Laser SurgeryUniversity, hospital or other
- Collaborators
- Merz North America, Inc.
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Radiesse, Xeomin, BeloteroTreatment with Xeomin, Radiesse, and/or Belotero |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >21
- No toxin treatment in last 3 months
- No filler treatment in last 3 months
- Glogau facing aging scale >=1
Key exclusion criteria (4 listed)
- Pregnancy
- Breastfeeding
- Allergy to prior Radiesse, Belotero, Xeomin products
- History of any facial nerve palsy (ie. Bell's Palsy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiesse, Xeomin, BeloteroRejuvenation with Radiesse, Xeomin, Belotero | Drug | Treatment |
Primary outcome
FACE-Q Subject Satisfaction
Time frame: 3 months
1 secondary outcome
Global Assessment Investigator Scale
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kachiu Lee, MD study director
Main Line Center for Laser Surgery
Eric Bernstein, MD principal investigator
Main Line Center for Laser Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Radiesse, Xeomin, Belotero in people with Photoaging, run by Main Line Center for Laser Surgery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACE-Q Subject Satisfaction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.