Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck

Skin Laxity Clinical Trial

Official title:

Feasibility Study: Evaluation of the Ulthera® System vs Thermage® for Lifting and Tightening of the Full Face and Neck

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01713985
• Other study ID #: ULT-135
• Status: Completed
• Phase: N/A
• First received: October 15, 2012
• Last updated: November 21, 2017
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups. Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the left side. Group B will receive Thermage on the right side of the face and neck and Ultherapy™ on the left side. 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.

Description:

This is a prospective, single-center, double-blinded, split-face, randomized pilot study. A triple Ultherapy® treatment and standard Thermage treatment will be provided to all subjects to the full half face, neck, and submental areas. Changes in face and neck skin laxity and wrinkles, from baseline and between study treatments, will be assessed at study follow-up visits. Patient satisfaction questionnaires will also be obtained.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female, age 30 to 65 years.

• Subject in good health.

• Skin laxity on the area(s) to be treated.

• 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 in the area(s) to be treated.

• Excessive skin laxity on the area(s) to be treated.

• Significant scarring in the area(s) to be treated.

• Open wounds or lesions in the area(s) to be treated.

• Severe or cystic acne on the area(s) to be treated.

• Presence of a metal stent or implant in the area(s) to be treated.

• Inability to understand the protocol or to give informed consent.

• Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within two weeks prior to study participation or during the study.

• Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.

• BMI equal to or greater than 25.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity
• Wrinkles

Intervention

Device:
• Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
• Thermage
Radiofrequency treatment focusing radiofrequency energy

Locations

Country	Name	City	State
United States	FACES+	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Lifting and Tightening of Skin	Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in skin laxity will be assessed based on photographs taken using the 3D Vectra digital imaging system.	180 days post treatment
Primary	Number of Participants with Wrinkle Reduction	Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in wrinkle reduction will be assessed based on photographs taken using the 3D Vectra digital imaging system	180 days post treatment
Secondary	Number of Participants with Eyebrow Lift	Quantitative measurements of eyebrow lift will be obtained at follow-up compared to baseline.	90 days post-treatment
Secondary	Number of Participants with Lower face and Neck Lift	Quantitative measurements of lower face and neck lift will be obtained at follow-up compared to baseline.	90 days post-treatment
Secondary	Number of Participants Reporting Treatment Satisfaction	Subjects will complete a split-face Patient Satisfaction Questionnaire at 180 days following study treatments.	180 days post-treatment