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Completed

NCT Number: NCT01422538

Ultherapy™ Treatment Following Sculptra® Treatment

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

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Key information

Conditions

Skin Laxity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EpiCentre Park Lane

Dallas, Texas, 75231, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ulthera® System

Device

Focused ultrasound energy delivered below the surface of the skin on the lower face.

Other names: Ultherapy™

Sculptra®

Drug

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 names: Poly-L-Lactic acid fillers

Sculptra® treatment followed by Ultherapy™ treatment

Other

Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.

Primary outcomes

  1. Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs.

    Time frame: 90 days post-treatment

    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.

Secondary outcomes

  1. Overall Aesthetic Improvement at 90 Days Post-treatment

    Time frame: 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.

  2. Overall Aesthetic Improvement at 180 Days Post-treatment

    Time frame: 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.

  3. Subject Satisfaction at 90 Days Post-treatment

    Time frame: 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.

  4. Subject Satisfaction at 180 Days Post-treatment

    Time frame: 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.

Other outcomes

  1. Subject's Assessment of Pain

    Time frame: During Ulthera study treatment

    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.

Sponsors and collaborators

Lead sponsor

Ulthera, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 24, 2011
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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