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Microneedling device for Hyperpigmentation

Waitlist Available
Research Sponsored by Cynosure, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has received fillers or neurotoxin injections in the last two weeks
Healthy male or female between the age of 40 - 65 years old
Screening 3 weeks
Treatment Varies
Follow Up 90 day follow up
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing whether a combination of radiofrequency and microneedling treatments is effective and safe for treating facial aging.

Eligible Conditions
  • Wrinkles
  • Solar Elastosis
  • Hyperpigmentation

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 day follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 day follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of Photos Identified Correctly of 30 Day Follow Up vs. Baseline
Percent of Photos Identified Correctly of 90 Day Follow Up vs. Baseline

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment2 Interventions
Subjects are to be treated with the RF device, followed by the microneedling device. Parameters may be adjusted throughout the treatment and will determined by the Clinician. Subjects will receive up to 4 treatments, spaced approximately 4 weeks apart.
First Studied
Drug Approval Stage
How many patients have taken this drug
RF device
Microneedling device

Find a Location

Who is running the clinical trial?

Cynosure, Inc.Lead Sponsor
51 Previous Clinical Trials
1,180 Total Patients Enrolled
Jennifer CiviokStudy DirectorDirector of Clinical Development
16 Previous Clinical Trials
436 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For this particular experiment, are elderly patients above the age of 65 able to participate?

"The age limit for patients that want to enroll in this clinical trial is 40 to 65. If a patient is under 18, there is 1 other trial they might be eligible for. There are 29 other trials available for patients over the age of 65."

Answered by AI

Are people needed for this research project?

"The latest information from clinicaltrials.gov tells us that this study is still recruiting patients. It began on June 15th, 2020 and was most recently updated on September 13th, 2020. So far, only 1 site has been enrolling the 35 required participants."

Answered by AI

Who qualifies to take part in this research?

"Up to 35 individuals meeting the following conditions can participate in this study: Between the ages of 40-65, must have moderate wrinkles or another form of photoaging such as dyschromia, be willing to receive treatments from the devices being studied, be able and willing to attend all required visits, and must sign the informed consent document."

Answered by AI
~16 spots leftby Feb 2025