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Thermage CPT for Treatment of Facial and Neck Laxity

V

Valeant Pharmaceuticals

Status

Completed

Conditions

Skin Aging

Treatments

Device: Thermage CPT

Study type

Interventional

Funder types

Industry

Identifiers

NCT01783496
13-136-TM-T

Details and patient eligibility

About

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

Enrollment

50 patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 6 patient groups

Framed Tip
Active Comparator group
Description:
Treatment with Thermage CPT Framed Tip
Treatment:
Device: Thermage CPT
Pattern Tip
Experimental group
Description:
Treatment with the Thermage CPT Pattern Tip
Treatment:
Device: Thermage CPT
Pattern Tip Group 2
Experimental group
Description:
Treatment with the Thermage CPT Pattern tip
Treatment:
Device: Thermage CPT
Total Tip
Experimental group
Description:
Treatment with the Thermage CPT Total tip
Treatment:
Device: Thermage CPT
Framed and Patterned Tip
Experimental group
Description:
Split face treatment with the Thermage CPT Framed and Patterned tips
Treatment:
Device: Thermage CPT
Total and Patterned Tip
Experimental group
Description:
Split face treatment with the Thermage CPT Total and Patterned tips
Treatment:
Device: Thermage CPT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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