Laxity; SkinNCT04102670
Combination Therapy for Rejuvenation of the Lower Face and Neck
A study testing Ultherapy, Xeomin and Belotero Balance in people with Laxity; Skin, run by Nashville Centre for Laser and Facial Surgery.
Trial summary
An investigator initiated trial in which 20 subjects with moderate to severe changes of the jawline, neck and décolletage will undergo combination treatment to achieve comprehensive rejuvenation of the jawline and neck. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laxity; Skin
- What is being tested?
- Ultherapy, Xeomin and Belotero Balance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Dec 2020
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Age at least 18 years
- Ability to understand the informed consent process
- Written informed consent is given prior to performing any study procedure
- Moderate to severe changes of the jawline as per the Merz Jawline Scale (Grade 3 or 4)
- Moderate to severe changes of the décolletage as per the Merz Decollete scale (Grade 3 or 4)
- Presence of prominent platysmal bands
Show all 12Show fewer
- Presence of horizontal necklace lines is not mandatory for inclusion but, if present, will be assessed on a 5 point scale
- Moderate to severe laxity of neck and decollete skin
- Body mass index (BMI) less than or equal to 30 kg/m2 at screening
- Female subjects are not pregnant (negative urine pregnancy test) and are willing to minimize the chance of becoming pregnant during the study period and follow up.
- Willing and able as assessed by the PI to follow study instruction and likely to complete all study assessments and required visits
- Willing to allow photographs to be used for educational and marketing purposes including on the internet and social media
Who cannot join
- • Age greater than 65 years
- Platysma neck bands at rest or excessively loose skin in lower face, neck, and décolletage area that, in the opinion of the Principal investigator (PI) or Subinvestigator (SI), may interfere with assessment
- Presence of thyroid enlargement, neck masses, salivary gland pathology, scars, or other features of the lower face/neck/décolletage area (excessive pre- or subplatysmal fat, jowling, skin laxity, etc.) that, in the opinion of the PI or SI may interfere with study assessments or which render the potential subject a poor candidate for treatment on the basis of low likelihood to respond favorably.
- Active dermatological disease or wounds, scarring, marked variation in pigmentation (poikiloderma of Civatte, focal hypopigmentation), or other anatomic characteristics in the lower face, neck or décolletage area that, in the opinion of the PI or SI, may interfere with study assessments.
- History of dysphagia
- Any medical condition that would represent a contraindication to Xeomin
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- Facial or neck hair (beard) that would interfere with photography or clinical assessments
- Any known uncontrolled systemic disease
- History of superficial aesthetic treatments to the face, neck or décolletage area (including but not limited to microdermabrasion, superficial chemical peels, microneedling, PRP, or topical retinoid use) 3 months prior to Day 0
- History of treatment to the face, neck or decolletage area with IPL, ablative or nonablative lasers, skin tightening devices, medium depth chemical peels, cryolipolysis or deoxycholic acid injections 6 months prior to Day 0
- History of soft tissue filler injection with HA in the lower face/neck/décolletage region 12 months prior to Day 0
- History of soft tissue filler injection with Radiesse or Sculptra in the lower face/neck/décolletage region 24 months prior to Day 0
- History of lower face/neck lifting, treatment with permanent fillers, jaw surgery, placement of implants or repair of jaw or LeFort type fractures in the mid or lower face/neck/décolletage region.
- Any planned surgical intervention in the lower face/neck/décolletage region during the study period
- Current enrollment in any other investigational trial
- History of weight loss surgery or procedures
- Females who are pregnant or nursing
- Known immunization or failure to respond to any botulinum toxin product
- History of Alpha Gal
- Known allergy or sensitivity to any of the components of the study treatments or any materials used in the study procedures
- Tattoos in the treatment area that may interfere with study assessments
- Any condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.
- Any subject who, in the PI's opinion, is not a good candidate to participate in this clinical trial
- Subjects with allergies to eggs
- Subjects with allergies to lidocaine
- Subjects with neurological disorders or contra-indications for Botox such as ALS, Lambert-Eaton Syndrome and Myasthenia Gravis Syndrome.
Trial locations and contacts
No sites are listed yet.
About this study
An investigator initiated trial in which 20 subjects with moderate to severe changes of the jawline, neck and décolletage will undergo combination treatment to achieve comprehensive rejuvenation of the jawline and neck.
Read the detailed description
Aging changes in the lower face, neck and decollete are complex and involve skin, subcutaneous tissue/SMAS and muscle. It follows therefore that rejuvenation of the jawline, neck and decollettage requires a multifactorial, combination approach. Microfocused Ultrasound (MFU-V, Ultherapy) has been demonstrated to noninvasively lift the skin of the submentum, neck, and reduce wrinkling of the décolletage.1-3 Injection of dilute calcium hydroxylapatite (Radiesse) has also demonstrated improvement of skin quality and reduction of wrinkles in the neck and décolletage skin.4 Combination therapy using MFU-V and Radiesse has been used successfully to improve the appearance of the neck and décolletage and botulinum toxin A has been used to improve jawline contouring and wrinkling of the décolletage.5,6 It is well recognized that skincare products such as MicroFirm Neck and Decollete Rejuvenating Complex improve skin quality and overall skin appearance. Further, Belotero Balance has been demonstrated to have optimal biophysical properties for placement in the superficial dermis and subsequent correction of etched lines.7 It is not surprising that horizontal "necklace lines" in the neck respond better to injection of Belotero Balance than any other reported treatment. Evaluation of the combination of skincare, botulinum toxin, MFU-V, and Radiesse for rejuvenation of the jawline, neck, and décolletage has not been studied.
Proposal: I propose an investigator initiated trial in which 20 subjects with moderate to severe changes of the jawline, neck and décolletage will undergo combination treatment to achieve comprehensive rejuvenation of the jawline and neck. Adequate time will be allowed for follow up to determine the complete effects of all treatments administered.
Materials and Methods: Neocutis MicroFirm Neck and Decollete treatment would be initiated at Day 0 and continued bid throughout the entire duration of the protocol.
Ultherapy will be used to treat the the lower face/neck and décolletage and will also be provided at Day 0. Ultherapy treatments would of course be customized to meet each patient's needs. The general guidelines that would be used to treat the lower face/jawline/neck would be the 4-4.5 transducer (approx. 350 lines) and the 7-3.0 transducer (approx. 460 lines). The décolletage area would be treated with the following transducers: 4-4.5 (approx. 120 lines), 7-3.0 (approx. 120 lines), and 10-1.5 (approx. 40 lines). As per consensus recommendations, Ultherapy will be administered prior to injectables.8 Dilute Radiesse (1:2 with injectable saline and 1% lidocaine without epinephrine) will be injected into the neck and décolletage at days 30, 90, and 150. Radiesse will be injected as per standard protocol using sterile technique and administered via a subcutaneous fanning approach. A total of 3 Radiesse injections will be administered at 8 weeks intervals (Days 30, 90, and 150). The amount of Dilute Radiesse used will be at the discretion of the Investigator but will not exceed 4.5mls for both treatment areas, the neck and décolletage.
Xeomin will be injected in a "Nefertiti Lift" pattern horizontally, parallel to the jawline, vertically in the platysma bands, and extending into the décolletage as indicated based on platysma muscle anatomy. A total dose of no more than 70U of Xeomin will be utilized. The first Xeomin injection will also be administered at Day 30. Additional Xeomin injections will be administered at Day 120. Subjects will be assessed at Day 44 +/- 3 days, and Day 134 +/- 3 days to assess outcomes of Xeomin injections and provide touch up injections if indicated.
Belotero Balance will be injected in horizontal necklace lines if present at Day 30 with reassessment for optional injection Follow up and possible touch up treatment will be offered at Day 44+/- 3 days.
- Conditions
- Laxity; Skin
- Being tested
- Ultherapy, Xeomin, Belotero Balance, Dilute Radiesse, Neocutis Micro Firm Face and Neck Cream
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltherapyDevice
Subjects will be treated with Ultherapy, which is a microfocused ultrasound, on the lower face, neck, and chest.
XeominDevice
Vertical neckbands, also known as platysma bands, will be injected with Xeomin to relax the bands.
Belotero BalanceDevice
Horizontal necklace lines will be filled using Beletero Balance.
Dilute RadiesseDevice
The chest area will be injected with dilute Radiesse to stimulate collagen.
Neocutis Micro Firm Face and Neck CreamOther
Neocutis Micro Firm Face and Neck Cream will be provided to subjects for topical use at home.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects will receive a combination of Ultherapy, Xeomin, Beletero Balance, Dilute Radiesse and Neocutis MicroFirm Face and Neck Cream Receives: Device: Ultherapy; Device: Xeomin; Device: Belotero Balance; Device: Dilute Radiesse; Other: Neocutis Micro Firm Face and Neck Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laxity of Jawline Scale
Laxity of Jawline Scale, scale ratings are 0=no sagging, 1=mild sagging, 2=moderate sagging, 3=severe sagging, 4=very severe sagging
Measured: Day 60
Decollete (chest) Wrinkle Scale
Decollete (chest) Wrinkle Scale, scale ratings are 0=no wrinkles, 1=mild wrinkles, 2=moderate wrinkles, 3=severe wrinkles, 4=very severe wrinkles
Measured: Day 60
Secondary outcomes (2)
Laxity of Jawline Scale
Laxity of Jawline Scale, scale ratings are 0=no sagging, 1=mild sagging, 2=moderate sagging, 3=severe sagging, 4=very severe sagging
Measured: Day 180
Decollete (chest) Wrinkle Scale
Decollete (chest) Wrinkle Scale, scale ratings are 0=no wrinkles, 1=mild wrinkles, 2=moderate wrinkles, 3=severe wrinkles, 4=very severe wrinkles
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laxity; SkinStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will receive a combination of Ultherapy, Xeomin, Beletero Balance, Dilute Radiesse and Neocutis MicroFirm Face and Neck Cream
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nashville Centre for Laser and Facial Surgery
- Sponsor type
- University, hospital or other
- Collaborators
- Merz North America, Inc.
- Responsible party
- Sponsor
- Investigators
- Brian S Biesman, MD, Principal investigator, The Practice of Brian S. Biesman, MD, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102670
- Sponsor's protocol ID
- IIT5370
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy for Rejuvenation of the Lower Face and Neck
- ClinicalTrials.gov ID
- NCT04102670
- Acronym / sponsor ID
- IIT5370
- Conditions
- Laxity; Skin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nashville Centre for Laser and Facial SurgeryUniversity, hospital or other
- Collaborators
- Merz North America, Inc.
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 25 Sep 2019 (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.
An investigator initiated trial in which 20 subjects with moderate to severe changes of the jawline, neck and décolletage will undergo combination treatment to achieve comprehensive rejuvenation of the jawline and neck.
Detailed description
Aging changes in the lower face, neck and decollete are complex and involve skin, subcutaneous tissue/SMAS and muscle. It follows therefore that rejuvenation of the jawline, neck and decollettage requires a multifactorial, combination approach. Microfocused Ultrasound (MFU-V, Ultherapy) has been demonstrated to noninvasively lift the skin of the submentum, neck, and reduce wrinkling of the décolletage.1-3 Injection of dilute calcium hydroxylapatite (Radiesse) has also demonstrated improvement of skin quality and reduction of wrinkles in the neck and décolletage skin.4 Combination therapy using MFU-V and Radiesse has been used successfully to improve the appearance of the neck and décolletage and botulinum toxin A has been used to improve jawline contouring and wrinkling of the décolletage.5,6 It is well recognized that skincare products such as MicroFirm Neck and Decollete Rejuvenating Complex improve skin quality and overall skin appearance. Further, Belotero Balance has been demonstrated to have optimal biophysical properties for placement in the superficial dermis and subsequent correction of etched lines.7 It is not surprising that horizontal "necklace lines" in the neck respond better to injection of Belotero Balance than any other reported treatment. Evaluation of the combination of skincare, botulinum toxin, MFU-V, and Radiesse for rejuvenation of the jawline, neck, and décolletage has not been studied.
Proposal: I propose an investigator initiated trial in which 20 subjects with moderate to severe changes of the jawline, neck and décolletage will undergo combination treatment to achieve comprehensive rejuvenation of the jawline and neck. Adequate time will be allowed for follow up to determine the complete effects of all treatments administered.
Materials and Methods: Neocutis MicroFirm Neck and Decollete treatment would be initiated at Day 0 and continued bid throughout the entire duration of the protocol.
Ultherapy will be used to treat the the lower face/neck and décolletage and will also be provided at Day 0. Ultherapy treatments would of course be customized to meet each patient's needs. The general guidelines that would be used to treat the lower face/jawline/neck would be the 4-4.5 transducer (approx. 350 lines) and the 7-3.0 transducer (approx. 460 lines). The décolletage area would be treated with the following transducers: 4-4.5 (approx. 120 lines), 7-3.0 (approx. 120 lines), and 10-1.5 (approx. 40 lines). As per consensus recommendations, Ultherapy will be administered prior to injectables.8 Dilute Radiesse (1:2 with injectable saline and 1% lidocaine without epinephrine) will be injected into the neck and décolletage at days 30, 90, and 150. Radiesse will be injected as per standard protocol using sterile technique and administered via a subcutaneous fanning approach. A total of 3 Radiesse injections will be administered at 8 weeks intervals (Days 30, 90, and 150). The amount of Dilute Radiesse used will be at the discretion of the Investigator but will not exceed 4.5mls for both treatment areas, the neck and décolletage.
Xeomin will be injected in a "Nefertiti Lift" pattern horizontally, parallel to the jawline, vertically in the platysma bands, and extending into the décolletage as indicated based on platysma muscle anatomy. A total dose of no more than 70U of Xeomin will be utilized. The first Xeomin injection will also be administered at Day 30. Additional Xeomin injections will be administered at Day 120. Subjects will be assessed at Day 44 +/- 3 days, and Day 134 +/- 3 days to assess outcomes of Xeomin injections and provide touch up injections if indicated.
Belotero Balance will be injected in horizontal necklace lines if present at Day 30 with reassessment for optional injection Follow up and possible touch up treatment will be offered at Day 44+/- 3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will receive a combination of Ultherapy, Xeomin, Beletero Balance, Dilute Radiesse and Neocutis MicroFirm Face and Neck Cream
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Ultherapy, Device: Xeomin, Device: Belotero Balance, Device: Dilute Radiesse, Other: Neocutis Micro Firm Face and Neck CreamSubjects will receive a combination of Ultherapy, Xeomin, Beletero Balance, Dilute Radiesse and Neocutis MicroFirm Face and Neck Cream |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- • Age at least 18 years
Key exclusion criteria (26 listed)
- • Age greater than 65 years
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 |
|---|---|---|
| UltherapySubjects will be treated with Ultherapy, which is a microfocused ultrasound, on the lower face, neck, and chest. | Device | Treatment |
| XeominVertical neckbands, also known as platysma bands, will be injected with Xeomin to relax the bands. | Device | Treatment |
| Belotero BalanceHorizontal necklace lines will be filled using Beletero Balance. | Device | Treatment |
| Dilute RadiesseThe chest area will be injected with dilute Radiesse to stimulate collagen. | Device | Treatment |
| Neocutis Micro Firm Face and Neck CreamNeocutis Micro Firm Face and Neck Cream will be provided to subjects for topical use at home. | Other | Treatment |
Primary outcome
Laxity of Jawline Scale
Time frame: Day 60
Laxity of Jawline Scale, scale ratings are 0=no sagging, 1=mild sagging, 2=moderate sagging, 3=severe sagging, 4=very severe sagging
Decollete (chest) Wrinkle Scale
Time frame: Day 60
Decollete (chest) Wrinkle Scale, scale ratings are 0=no wrinkles, 1=mild wrinkles, 2=moderate wrinkles, 3=severe wrinkles, 4=very severe wrinkles
2 secondary outcomes
Laxity of Jawline Scale
Time frame: Day 180
Decollete (chest) Wrinkle Scale
Time frame: Day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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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.
Brian S Biesman, MD principal investigator
The Practice of Brian S. Biesman, MD, PLLC
Questions about this trial
What is this clinical trial studying?
A study testing Ultherapy, Xeomin and Belotero Balance in people with Laxity; Skin, run by Nashville Centre for Laser and Facial Surgery.
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 12 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda Spear, CCRC (6153291110, amanda@drbiesman.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laxity of Jawline Scale (time frame: Day 60). The study lists 2 primary outcomes in all. 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 25 Sep 2019.