Ultherapy™ Treatment Following Sculptra® Treatment

Skin Laxity Clinical Trial

Official title:

Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Following Sculptra® Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422538
• Other study ID #: ULT-113
• Status: Completed
• Phase: N/A
• First received: August 22, 2011
• Last updated: November 16, 2017
• Start date: May 2011
• Est. completion date: September 2012

Study information

• Verified date: November 2017
• Source: Merz North America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.

Description:

This study is a prospective,single-center, randomized clinical trial. Up to thirty (30) subjects will be treated. Enrolled subjects will be assigned to one of three (3) groups. Up to 10 subjects per group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male or female, aged 35 to 60 years.

• Subject in good health.

• Skin laxity in the lower face and neck.

• Grade 1 and 2 on the Knize Scale

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 and neck.

• Excessive skin laxity on the face and neck.

• No scarring in areas to be treated.

• Any open facial wounds or lesions.

• Acne on the face.

• Patients who have a history with keloid formation or hypertropic scarring

• Patients who have a hypersensitivity to injectable poly-L-lactic acid

• Presence of a metal stent or implant in the facial area to be treated.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Intervention

Device:
• Ulthera® System
Focused ultrasound energy delivered below the surface of the skin on the lower face.

Drug:
• Sculptra®
Injectable filler reconstituted prior to use. Injections are administered to the lower face in a combination of cross-hatching and fanning techniques. The Sculptra is injected in two treatment sessions 6 weeks apart.

Other:
• Sculptra® treatment followed by Ultherapy™ treatment
Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.

Locations

Country	Name	City	State
United States	EpiCentre Park Lane	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject's Assessment of Pain	Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Pain assessment data were obtained from Group A and Group C subjects only.	During Ulthera study treatment
Primary	Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs.	Three masked assessors reviewed pre- and 90 days post-treatment photos from 29 subjects who returned for their 90-day follow-up visit, assessing for improvement in skin laxity at 90 days post-treatment compared to baseline, i.e., lifted and tightened skin in the areas treated with the assigned study treatment based on the assigned study arm.	90 days post-treatment
Secondary	Overall Aesthetic Improvement at 90 Days Post-treatment	At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows: = Very Much Improved; = Much Improved; = Improved; = No Change; = Worse "Any Improvement" includes subjects assessed in categories 1-3.	90 days post-treatment.
Secondary	Overall Aesthetic Improvement at 180 Days Post-treatment	At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows: = Very Much Improved; = Much Improved; = Improved; = No Change; = Worse "Any Improvement" includes subjects assessed in categories 1-3.	180 days post-treatment
Secondary	Subject Satisfaction at 90 Days Post-treatment	Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 90 days post-treatment Responses were tabulated.	90 days post-treatment.
Secondary	Subject Satisfaction at 180 Days Post-treatment	Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 180 days post-treatment Responses were tabulated.	180 days post-treatment