Cutis Laxa
Conditions
Keywords
Skin laxity
Brief summary
The purpose of this study is to demonstrate superiority of treatment with the Ulthera System compared to untreated control for the improvement of skin laxity of the lower face, submental area and neck and to demonstrate the safety of treatment with the Ulthera System for the improvement of skin laxity of the lower face, submental area and neck.
Interventions
DEVICEUlthera System
Participants will receive treatment with the Ulthera system which consists of three primary components: the control unit, handpiece and interchangeable transducers.
Sponsors
Merz North America, Inc.
Ulthera, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Mild to moderate lower face, submental and/or neck laxity, that is amenable to improvement with non-invasive intervention and not severe enough for surgical intervention. * Willing to abstain from all other aesthetic treatments on ANY part of the face, submentum or neck, including but not limited to injectable fillers, implants, neurotoxin, skin peels, laser treatments, surgical treatments, etc. for the clinical investigation's duration. * Willing and able to refrain from chronic use of aspirin, ibuprofen, naproxen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) for 10 to 14 days post-treatment. * Has an adequate understanding of the Chinese language. * Willing and able to comply with protocol requirements.
Exclusion criteria
* Scarring in area(s) to be treated. * Any active implants. * Any metallic implants in area(s) to be treated. * Any open wounds or lesions, including active herpes simplex, in the area(s) to be treated. * Presence of an active systemic or local skin disease, including active, cystic, or severe inflammatory acne in the area(s) to be treated. * History of keloid formation or hypertrophic scarring. * History of the following cosmetic treatments in area(s) to be treated: * Skin-tightening procedure, * Injectable crosslinked hyaluronic acid (HA)/collagen temporary dermal fillers of the lower face, submentum or neck within the past 12 months. * Injectable non-crosslinked HA dermal fillers of the lower face, submentum or neck within the past 6 months. * Injectable semi-permanent/permanent facial fillers * Neurotoxin treatment of the lower face, submentum or neck within the past 6 months. * Liposuction of the lower face, submentum or neck within the last 12 months. * Fat grafting of the lower face, submentum or neck within the last 12 months. * Deoxycholic acid within the last 12 months; and/or * Chemical peeling or dermabrasion treatments within the past 12 months. * Cryolipolysis * Had prior surgery in the lower-facial area and/or neck/submentum or has a permanent implant or graft in the lower-facial area that could interfere with effectiveness assessments. * Has undergone oral surgery in the past 30 days. * Participants who have used isotretinoin or other retinoid medications within 6 months prior to enrollment or have applied topical retinoid-containing medications on the face or neck area within 2 weeks prior to enrollment or planning such treatments during the study period. * Marked facial asymmetry, deep dermal scarring, or thick sebaceous skin in the full face. * Severe solar elastosis. * Facial nerve palsy or history of facial nerve palsy. * Tattoos in the area(s) to be treated (excluding microblading eyebrow). * Current smoker or history of smoking in the last 12 months. * Current daily user of any nicotine-containing products * Is a female of childbearing potential1 and not using medically effective birth control 2 or is pregnant, lactating, or planning to become pregnant during the clinical investigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With at Least "Improved" in Lower Face, Submental and Neck Skin Laxity on Global Aesthetic Improvement Scale as Determined by the Blinded Live Evaluator (eGAIS) at Day 90 Compared to Baseline Photographs | Day 90 | Blinded live evaluator will use eGAIS to evaluate global aesthetic improvement in the facial appearance of participants. The GAIS is a 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Higher scores indicate a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Three Independent, Blinded Raters GAIS (rGAIS) Score in Lower Face, Submental and Neck Skin Laxity at Day 90 Compared to Baseline Photographs | Day 90 | Three independent, blinded raters will use rGAIS to evaluate global aesthetic improvement in the facial appearance of participants. The GAIS is a 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Higher scores indicate a worse outcome. |
| Treating Investigator's GAIS (iGAIS) Score in Lower Face, Submental and Neck Skin Laxity at Day 90 Compared to Baseline Photographs | Day 90 | Treating investigators will use the iGAIS to assess overall aesthetic improvement of the lower face, submentum, and neck. The GAIS is a 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Higher scores indicate a worse outcome. This outcome measure is prespecified for the Treatment Group only. |
| Participant's GAIS (pGAIS) Scores in Lower Face, Submental Skin and Neck Laxity at Day 90 Compared to Baseline Photographs | Day 90 | Participants will self-report using the pGAIS to assess overall aesthetic improvement of the lower face, submentum, and neck. The pGAIS is a 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Higher scores indicate a worse outcome. This outcome measure is prespecified for the Treatment Group only. |
Countries
China
Contacts
CONTACTPublic Disclosure Manager Merz Aesthetics
STUDY_DIRECTORMerz Medical Expert
Merz North America, Inc.
Outcome results
None listed