Combination Therapy for Rejuvenation of the Lower Face and Neck

NCT04102670 | Unknown

• 1 other identifier: IIT5370
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Laxity; Skin

Outcome Measures

Primary 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

  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

  Day 60

Secondary Outcomes (2)

• Laxity of Jawline Scale

  Day 180

• Decollete (chest) Wrinkle Scale

  Day 180

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects will receive a combination of Ultherapy, Xeomin, Beletero Balance, Dilute Radiesse and Neocutis MicroFirm Face and Neck Cream

Device: Ultherapy; Device: Xeomin; Device: Belotero Balance; Device: Dilute Radiesse; Other: Neocutis Micro Firm Face and Neck Cream

Interventions

Ultherapy DEVICE

Subjects will be treated with Ultherapy, which is a microfocused ultrasound, on the lower face, neck, and chest.

Treatment

Xeomin DEVICE

Vertical neckbands, also known as platysma bands, will be injected with Xeomin to relax the bands.

Treatment

Belotero Balance DEVICE

Horizontal necklace lines will be filled using Beletero Balance.

Treatment

Dilute Radiesse DEVICE

The chest area will be injected with dilute Radiesse to stimulate collagen.

Treatment

Neocutis Micro Firm Face and Neck Cream OTHER

Neocutis Micro Firm Face and Neck Cream will be provided to subjects for topical use at home.

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nashville Centre for Laser and Facial Surgery: lead
• Merz North America, Inc.: collaborator

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Brian S Biesman, MD

  The Practice of Brian S. Biesman, MD, PLLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Spear, CCRC

CONTACT

6153291110; amanda@drbiesman.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will receive a combination of Ultherapy, Xeomin, Beletero Balance, Dilute Radiesse and Neocutis MicroFirm Face and Neck Cream

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 25, 2019
• Study Start: October 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 25, 2019

Record last verified: 2019-09