Status:
UNKNOWN
Combination Therapy for Rejuvenation of the Lower Face and Neck
Lead Sponsor:
Nashville Centre for Laser and Facial Surgery
Collaborating Sponsors:
Merz North America, Inc.
Conditions:
Laxity; Skin
Eligibility:
All Genders
18-65 years
Phase:
NA
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 th...
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 requ...
Eligibility Criteria
Inclusion
- • 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
- 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
Exclusion
- • 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
- 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.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04102670
Start Date
October 1 2019
End Date
December 1 2020
Last Update
September 25 2019
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