Health TrialsbyHealthPanel

A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment

ConditionsWrinkleLax SkinLines Skin
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorBausch Health Americas, Inc.

About this trial

A prospective, 180-day, randomized, multicenter, independent blinded evaluators, controlled study of treatment with the Thermage FLX System

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Be an adult female or male, ≥30 - ≤60 years of age.

Disqualifiers

Participant is pregnant or breast feeding or trying to become pregnant for 3 months prior to the screening visit or during the study.

Trial design

Design model

Single group

Treatments tested in this trial

  • Thermage FLX

    Device

    The Thermage FLX System ('System') is a monopolar, capacitively coupled radiofrequency System designed for use in non-invasive dermatological procedures

Treatment groups

164 Participants
are divided into 2 treatment groups
Group A: Control ArmActive comparator 1 intervention
Group B: Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary Endpoint

Proportion of participants with any improvement on iGAIS at Day 90 as assessed by independent blinded evaluators.

Time frame
90 days

Secondary outcomes

1

Secondary Endpoint

Proportion of participants with any improvement on iGAIS, Fitzpatrick Wrinkle Scale, Facial Laxity Rating Scale, IBSA Inner Upper Arm Laxity Scale, Abdominal Laxity Scale at Day 90 and 180.

Time frame
180 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bausch Health Americas, Inc.

Lead sponsor

Source ClinicalTrials.gov
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