Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System

NCT01368874 | Completed Results

• 1 other identifier: ULT-110
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

Brief Summary

This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with a non-invasive treatment to obtain lift and tightening of facial and neck tissue utilizing the Ulthera® System to deliver ultrasound energy in a focused manner below the surface of the skin.

Conditions

Facial and Neck Skin Laxity

Outcome Measures

Primary Outcomes (2)

• Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity

  Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.

  90 Days post-treatment

• Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP

  Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis. A data set of 42 of the 61 participants were re-analyzed. Data were removed for 19 participants whose pre-treatment and/or post-treatment photos were of poor photo quality, i.e., poor lighting, poor focus, poor positioning, creating the potential for biasing the masked assessment results.

  90 Days post-treatment

Secondary Outcomes (8)

• Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.

  60 days post-treatment

• Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.

  90 days post-treatment

• Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity , as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.

  180 days post-treatment

• Patient Satisfaction 90 Days Post-treatment

  90 Days post-treatment

• Patient Satisfaction Questionnaire 180 Days Post-treatment

  180 days post-treatment

Other Outcomes (1)

• Subjects' Assessment of Pain

  During Ulthera treatment

Study Arms (3)

Group A

ACTIVE COMPARATOR

Ulthera® System treatment of the submental and submandibular regions at two treatment depths, and the lower neck region at one treatment depth.

Device: Ulthera® System treatment

Group B

ACTIVE COMPARATOR

Ulthera® System treatment of skin above the jawline, as well as the submental, submandibular and lower neck regions.

Device: Ulthera® System treatment

Group C

ACTIVE COMPARATOR

Ulthera® System treatment of the submental, submandibular, and the lower neck regions at two treatment depths.

Device: Ulthera® System treatment

Interventions

Ulthera® System treatment DEVICE

Single treatment of focused ultrasound energy delivered below the surface of the skin.

Also known as: Ultherapy

Group A; Group B; Group C

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 30 to 65 years.
• Subject in good health.
• Skin laxity in the lower face and neck.
• Willingness and ability to comply with protocol requirements and return for follow-up visits.
• Provides written informed consent and HIPAA authorization.

You may not qualify if:

• Pregnant or lactating.
• Presence of an active systemic or local skin disease that may affect wound healing.
• Severe solar elastosis.
• Excessive subcutaneous fat in the face and lower neck.
• Excessive skin laxity on the face and neck.
• Significant scarring in areas to be treated.
• Significant open facial wounds or lesions.
• Severe or cystic acne on the face.
• Presence of a metal stent or implant in the facial area to be treated.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (2)

Baumann Cosmetic and Research Institute

Miami Beach, Florida, 33140, United States

Location

Zel Skin and Laser Specialists

Edina, Minnesota, 55424, United States

Location

MeSH Terms

Conditions

Facies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals

clinicaltrials@merz.com

Study Officials

• Leslie Baumann, M.D.

  Baumann Cosmetic and Research Institute

  PRINCIPAL INVESTIGATOR

• Brian Zelickson, M.D.

  Zel Skin and Laser Specialist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 8, 2011
• Study Start: March 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: January 1, 2012
• Last Updated: December 13, 2017
• Results First Posted: November 20, 2013

Record last verified: 2014-04

Locations

US (2)