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Laser Therapy

other for Acne Scars

N/A
Waitlist Available
Led By Stephen Ronan, M.D.
Research Sponsored by Cutera Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks post-screening through study completion, an average of 1 year.
Awards & highlights

Study Summary

The purpose of this pivotal investigation is to evaluate the efficacy and safety of the Cutera enlighten multi-wavelength 532 nm and 1064 nm Nd:YAG picosecond pulse duration laser and an investigational micro-lens array (MLA) handpiece attachment for improvement of acne scars.

Eligible Conditions
  • Acne Scars

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks post-screening through study completion, an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks post-screening through study completion, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Correct Identification of the 12 Weeks Post-final Treatment Photographs From the Baseline Photographs by at Least 2 of the 3 Blinded Reviewers in 75% of the Patients.
Secondary outcome measures
1. Efficacy of Cutera enLighten device with MLA handpiece attachment as assessed by Investigator (GAIS).
2. Satisfaction level and assessment of Acne Scar improvement as assessed by Subject.
3. Efficacy of Cutera enLighten device with MLA handpiece attachment as assessed by Investigator (ASAS).
+1 more
Other outcome measures
Frequency and severity of device related Adverse Events of Cutera enLighten device with MLA handpiece attachment

Trial Design

1Treatment groups
Experimental Treatment
Group I: otherExperimental Treatment1 Intervention
no arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
other
2020
N/A
~2070

Find a Location

Who is running the clinical trial?

Cutera Inc.Lead Sponsor
42 Previous Clinical Trials
1,091 Total Patients Enrolled
Stephen Ronan, M.D.Principal InvestigatorCutera Research Center
4 Previous Clinical Trials
88 Total Patients Enrolled
Neil Sadick, M.D.Principal InvestigatorSadick Dermatology/Sadick Research Center
2 Previous Clinical Trials
181 Total Patients Enrolled

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
Sadick Dermatology/Sadick Research Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Have atrophic acne scarring on cheeks , scars are about 3 yrs old now. scar morphology is mostly boxcar , linear, and icepick ; have been treated with 4x Intensif RF , 3x fraxel restore dual, 4x sessions of tca cross. Looking to explore new treatments in scarring. fitzpatrick skin type 3. resides just outside of NYC in nj , able to travel for treatment and follow up.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
enLighten Laser With MLA Handpiece for Treatment of Moderate and Severe Acne Scars
2017. "enLighten Laser With MLA Handpiece for Treatment of Moderate and Severe Acne Scars". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03284333.
~6 spots leftby Apr 2025
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