Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck
16 juni 2026 uppdaterad av: Merz North America, Inc.
Evaluation of the Effectiveness and Safety of the Ulthera® System for Treating Skin Laxity in the Lower Face, Submentum and Neck
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.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Beräknad)
218
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Public Disclosure Manager Merz Aesthetics
- Telefonnummer: +1 984-301-3095
- E-post: Aesthetic.Trials@merz.com
Studieorter
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100034
- Rekrytering
- Merz Investigative Site
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Beijing, Beijing Municipality, Kina, 100730
- Rekrytering
- Merz Investigative Site
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Guangdong
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Guangzhou, Guangdong, Kina, 510317
- Rekrytering
- Merz Investigative Site
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Jiangsu
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Nanjing, Jiangsu, Kina, 210003
- Rekrytering
- Merz Investigative Site
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Shaanxi
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Xi'an, Shaanxi, Kina, 710004
- Rekrytering
- Merz Investigative Site
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200040
- Rekrytering
- Merz Investigative Site
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Shanghai, Shanghai Municipality, Kina, 200443
- Rekrytering
- Merz Investigative Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Treatment With Ulthera System
Participants randomized to receive a single treatment with Ulthera system to lower face, submentum and neck on Day 1.
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Participants will receive treatment with the Ulthera system which consists of three primary components: the control unit, handpiece and interchangeable transducers.
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Övrig: Control/Delayed treatment With Ulthera System
Participants will remain untreated until Day 90 and then receive a single treatment with Ulthera system to lower face, submentum and neck.
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Participants will receive treatment with the Ulthera system which consists of three primary components: the control unit, handpiece and interchangeable transducers.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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
Tidsram: Day 90
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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.
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Day 90
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Three Independent, Blinded Raters GAIS (rGAIS) Score in Lower Face, Submental and Neck Skin Laxity at Day 90 Compared to Baseline Photographs
Tidsram: Day 90
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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.
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Day 90
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Treating Investigator's GAIS (iGAIS) Score in Lower Face, Submental and Neck Skin Laxity at Day 90 Compared to Baseline Photographs
Tidsram: Day 90
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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.
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Day 90
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Participant's GAIS (pGAIS) Scores in Lower Face, Submental Skin and Neck Laxity at Day 90 Compared to Baseline Photographs
Tidsram: Day 90
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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.
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Day 90
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Merz Medical Expert, Merz North America, Inc.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 juni 2026
Primärt slutförande (Beräknad)
1 december 2026
Avslutad studie (Beräknad)
1 mars 2027
Studieregistreringsdatum
Först inskickad
22 maj 2026
Först inskickad som uppfyllde QC-kriterierna
22 maj 2026
Första postat (Faktisk)
29 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ULT-LAX-CN002
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Ja
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .