Completed
Evaluation of the 755nm Alexandrite Laser for the Treatment of Scars
What is being tested
755nm Alexandrite Laser
Device
Who is being recruted
Fibrosis+1
+ Pathologic Processes
+ Pathological Conditions, Signs and Symptoms
From 18 to 85 Years
+14 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: June 2012
Summary
Principal SponsorCynosure, Inc.
Last updated: January 14, 2021
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2012
Actual date on which the first participant was enrolled.Evaluate the safety and efficacy of removing unwanted scars using a 755nm Alexandrite laser.
Principal SponsorCynosure, Inc.
Last updated: January 14, 2021
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
33 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
FibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsCicatrix
Criteria
4 inclusion criteria required to participate
Has unwanted scars (including atrophic, hypertrophic, hyper or hypo pigmented, erythematous )and wishes to undergo laser treatments to remove or improve them
Is a healthy male or female between 18 and 85 years old
Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits
Is willing to consent to participate in the study
10 exclusion criteria prevent from participating
Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications
Has a history of keloid scarring
Has a history of squamous cell carcinoma or melanoma
Has active localized or systemic infection
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Experimental755nm Alexandrite Laser
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Laser & Skin Surgery Center of New York
New York, United StatesOpen Laser & Skin Surgery Center of New York in Google MapsCompletedOne Study Center