Treatment of the Face and Neck With Lower Ulthera System Energy Settings
10 november 2017 bijgewerkt door: Ulthera, Inc
Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck With Lower Energy Settings
Up to 60 subjects will be enrolled.
Enrolled subjects will receive one Ulthera® treatment on the face and neck.
Follow-up visits will occur at 90 and 180 days post-treatment.
Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This trial is a prospective, single-site, double-blinded, randomized, split-face design.
Subjects will be randomized to one of three treatment groups, receiving treatment using different energy levels.
Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
47
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Arizona
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Mesa, Arizona, Verenigde Staten, 85210
- Ulthera, Inc.
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
30 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Male or female, age 30 to 65 years.
- Subject in good health.
- Skin laxity on the face and neck
Exclusion Criteria:
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat in the face or neck.
- Excessive skin laxity on the face or neck.
- Significant scarring in areas to be treated.
- Open wounds or lesions in the area to be treated.
- Severe or cystic acne on the area to be treated.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Group A
Subjects will receive an increased density Ulthera System Treatment over the full face but with the energy turned down to the second highest level of four possible energy settings on one side of the face.
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Gefocuste ultrasone energie afgegeven onder het huidoppervlak
Andere namen:
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Actieve vergelijker: Group B
Subjects will receive an increased density guideline Ulthera System Treatment over the full face but with the energy turned down to the lowest level of four possible energy settings on one side of the face.
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Gefocuste ultrasone energie afgegeven onder het huidoppervlak
Andere namen:
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Actieve vergelijker: Group C
Subjects will receive an increased density guideline Ulthera System Treatment over the full face with the exception that a 4 MHz transducer will be used on the upper face in place of a7 MHz transducer, with the energy turned down to the lowest level of four possible energy settings.
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Gefocuste ultrasone energie afgegeven onder het huidoppervlak
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Subjects' Assessment of Pain During Treatment With Lower Energy Settings
Tijdsspanne: Participants were assessed for the duration of study treatment, an average of 75 minutes
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Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible. Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed. |
Participants were assessed for the duration of study treatment, an average of 75 minutes
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Overall Improvement in Skin Laxity on the Face and Neck
Tijdsspanne: 90 days post-treatment
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A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors.
Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group.
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90 days post-treatment
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Quantitative Assessment of Brow Lift at 90 Days Post-treatment
Tijdsspanne: 90 days post-treatment
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Quantitative assessment and analysis of brow lift from baseline to 90 days post-treatment was completed comparing brow lift achieved using standard energy settings compared to adjusted energy settings.
The number of subjects with 1 mm or more brow lift is reported.
Note: Because the submental region was treated using standard energy settings in all study groups, a quantitative analysis of lift in this region between the study groups would most likely not be informative, and therefore was not completed.
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90 days post-treatment
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Subject Assessment of Improvement at 90 Days Post-treatment
Tijdsspanne: 90 days post-treatment
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Subjects completed a Patient Assessment Questionnaire at 90 days post-treatment by referring to their image in a mirror, their 90-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.
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90 days post-treatment
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Subject Assessment of Improvement at 180 Days Post-treatment
Tijdsspanne: 180 days post-treatment
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Subjects completed a Patient Assessment Questionnaire at 180 days post-treatment by referring to their image in a mirror, their 180-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.
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180 days post-treatment
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Steven H Gitt, MD, Ulthera, Inc
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 september 2011
Primaire voltooiing (Werkelijk)
1 juni 2012
Studie voltooiing (Werkelijk)
1 oktober 2012
Studieregistratiedata
Eerst ingediend
15 oktober 2012
Eerst ingediend dat voldeed aan de QC-criteria
22 oktober 2012
Eerst geplaatst (Schatting)
25 oktober 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 december 2017
Laatste update ingediend die voldeed aan QC-criteria
10 november 2017
Laatst geverifieerd
1 november 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ULT-300
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