Ultherapy™ Treatment Following Sculptra® Treatment

Ulthera

Status: Completed

Conditions: Skin Laxity

Treatments: Other: Sculptra® treatment followed by Ultherapy™ treatment; Drug: Sculptra®; Device: Ulthera® System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01422538

ULT-113

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Group A

Active Comparator group

Description:

Subjects will receive Ulthera® System alone.

Treatment:

Device: Ulthera® System

Group B

Active Comparator group

Description:

Sculptra® only

Treatment:

Drug: Sculptra®

Group C

Active Comparator group

Description:

Sculptra® treatment followed by Ultherapy™ treatment

Treatment:

Other: Sculptra® treatment followed by Ultherapy™ treatment