MedPath

Evaluation of the Ulthera® System for Treatment of the Face and Neck

Not Applicable
Terminated
Conditions
Rhytids
Skin Laxity
Wrinkles
Registration Number
NCT01713907
Lead Sponsor
Ulthera, Inc
Brief Summary

Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Detailed Description

This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve jawline definition and submental skin laxity. Changes from baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
15
Inclusion Criteria
  • Male or female, aged 30 to 65 years.
  • Subject in good health.
  • Score of 1 to 6 on the Fitzpatrick's Classification of Wrinkling Scale.
  • Mild to moderate rhytids in the periorbital or perioral region.
  • Mild to moderate laxity in the areas to be treated, which includes length and depth of lines.
  • Mild to moderate vertical perioral lines
  • Mild to moderate marionette lines.
  • Subjects who desire lift and tightening of periorbital, perioral, and cheek tissue, improvement in jawline definition and/or submental skin laxity
  • Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
  • Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Exclusion Criteria
  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Severe solar elastosis.
  • Excessive subcutaneous fat on the cheek.
  • Excessive skin laxity on the lower face and neck.
  • Deep wrinkles, numerous lines, with or without redundant skin in the areas to be treated.
  • Excessive hooding with or without redundant skin in the areas to be treated.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Improvement in facial wrinkles and lifting and tightening of skin90 days post-treatment

Outcome measure determined based on a masked, qualitative assessment of standardized photographs at 90 days post-treatment compared to baseline

Secondary Outcome Measures
NameTimeMethod
Overall patient satisfaction90 and 180 day post-treatment

Determined based on Patient Satisfaction and Quality of Life questionnaire scores.

Overall aesthetic improvementParticipants will be followed up to 180 days post-treatment

Aesthetic improvement determined based on GAIS scores at follow-up, and the change in facial pigmentation and Fitzpatrick Facial Wrinkle Scale scores from baseline.

Trial Locations

Locations (1)

Dermatology, Cosmetic & Laser Surgery

🇺🇸

Rockville, Maryland, United States

Dermatology, Cosmetic & Laser Surgery
🇺🇸Rockville, Maryland, United States

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