Thermage CPT for Treatment of Facial and Neck Laxity

NCT ID: NCT01783496

Last Updated: 2017-06-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-02-28

Brief Summary

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The purpose of this study to evaluate treatment with the Thermage CPT system for facial and neck laxity.

Detailed Description

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Conditions

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Skin Aging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Framed Tip

Treatment with Thermage CPT Framed Tip

Group Type ACTIVE_COMPARATOR

Thermage CPT

Intervention Type DEVICE

Treatment with Thermage patterned, total, or framed tip

Pattern Tip

Treatment with the Thermage CPT Pattern Tip

Group Type EXPERIMENTAL

Thermage CPT

Intervention Type DEVICE

Treatment with Thermage patterned, total, or framed tip

Pattern Tip Group 2

Treatment with the Thermage CPT Pattern tip

Group Type EXPERIMENTAL

Thermage CPT

Intervention Type DEVICE

Treatment with Thermage patterned, total, or framed tip

Total Tip

Treatment with the Thermage CPT Total tip

Group Type EXPERIMENTAL

Thermage CPT

Intervention Type DEVICE

Treatment with Thermage patterned, total, or framed tip

Framed and Patterned Tip

Split face treatment with the Thermage CPT Framed and Patterned tips

Group Type EXPERIMENTAL

Thermage CPT

Intervention Type DEVICE

Treatment with Thermage patterned, total, or framed tip

Total and Patterned Tip

Split face treatment with the Thermage CPT Total and Patterned tips

Group Type EXPERIMENTAL

Thermage CPT

Intervention Type DEVICE

Treatment with Thermage patterned, total, or framed tip

Interventions

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Thermage CPT

Treatment with Thermage patterned, total, or framed tip

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 25 - 65 years of age
* Moderate facial and neck laxity
* Subject has the ability to follow the study instructions, is willing to be available on the specific required study visit days, and is willing to complete all study visit procedures and assessments.
* Subject must understand the research nature of this study and sign an Institutional Review Board (IRB)-approved informed consent prior to the performance of any study specific procedure or assessment.
* Subject agrees not to undergo excluded procedures on the face and neck for the duration of study.

Exclusion Criteria

* Subject is pregnant or breast feeding, or trying to become pregnant for three months prior to or during the study.
* Pacemaker, internal defibrillator, or other implanted electronic device
* Subject has an active localized infection in the treatment area(s) or an uncontrolled systemic infection.
* Subject has had prior cosmetic procedures on the treatment area(s) within six months of the baseline visit.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Valeant Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald Wheeland, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Solta Medical Aesthetic Center

Hayward, California, United States

Site Status

Countries

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United States

Other Identifiers

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13-136-TM-T

Identifier Type: -

Identifier Source: org_study_id

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