Treatment of the Face and Neck With Lower Ulthera System Energy Settings
10. november 2017 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
47
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Arizona
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Mesa, Arizona, Forente stater, 85210
- Ulthera, Inc.
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
30 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 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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Fokusert ultralydenergi levert under overflaten av huden
Andre navn:
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Aktiv komparator: 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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Fokusert ultralydenergi levert under overflaten av huden
Andre navn:
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Aktiv komparator: 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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Fokusert ultralydenergi levert under overflaten av huden
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Subjects' Assessment of Pain During Treatment With Lower Energy Settings
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Quantitative Assessment of Brow Lift at 90 Days Post-treatment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Steven H Gitt, MD, Ulthera, Inc
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2011
Primær fullføring (Faktiske)
1. juni 2012
Studiet fullført (Faktiske)
1. oktober 2012
Datoer for studieregistrering
Først innsendt
15. oktober 2012
Først innsendt som oppfylte QC-kriteriene
22. oktober 2012
Først lagt ut (Anslag)
25. oktober 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. desember 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. november 2017
Sist bekreftet
1. november 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ULT-300
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