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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A healthy male or female 18 - 65 years of age.
Healthy male or female aged 18-65
Must not have
Has an active localized or systemic infection, or an open wound in area being treated
Takes medication which is known to increase sensitivity to sunlight
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 90 day follow up
Awards & highlights
No Placebo-Only Group
Summary
This trial tested a laser device to treat acne scars on darker skin tones. Results showed it was safe and effective.
Who is the study for?
This trial is for healthy adults aged 18-65 with skin types V or VI who have acne scars on their face. Participants must not have had recent unprotected sun exposure, a history of keloid formation, immune disorders, coagulation issues, or be pregnant. They should agree to avoid other facial treatments and attend all study visits.
What is being tested?
The trial is testing the safety and effectiveness of an Alexandrite laser device in treating acne scars on darker skin tones (types V and VI). The goal is to see how well it works and monitor any side effects during treatment.
What are the potential side effects?
Potential side effects may include changes in skin pigmentation, discomfort at the treatment site, swelling, redness, blistering or potential scarring. There might also be risks related to light sensitivity or triggering pre-existing conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old and in good health.
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I am between 18 and 65 years old and in good health.
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I have had skin cancer or suspicious skin lesions in the area to be treated.
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I am on medication that affects how my wounds heal.
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I have not been exposed to the sun without protection or used tanning products in the last 4 weeks.
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I have a blood clotting disorder or I'm on blood thinners, including high-dose aspirin.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an infection or an open wound in the area that needs treatment.
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I take medication that makes my skin more sensitive to sunlight.
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I have moles that could turn into skin cancer.
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I have a serious illness like lupus.
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I have been treated with gold therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 90 day follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 90 day follow up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Photographic Evaluation of Changes in Treatment Areas
Secondary study objectives
Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which
Photographic Evaluation of Treatment Areas
Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS)
+2 moreAwards & 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: Alexandrite LaserExperimental Treatment1 Intervention
Single arm, self-controlled
Find a Location
Who is running the clinical trial?
Cynosure, Inc.Lead Sponsor
51 Previous Clinical Trials
1,197 Total Patients Enrolled
6 Trials studying Acne Scars
173 Patients Enrolled for Acne Scars
Jennifer CiviokStudy DirectorCynosure, Inc.
16 Previous Clinical Trials
453 Total Patients Enrolled
3 Trials studying Acne Scars
112 Patients Enrolled for Acne Scars
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old and in good health.I have acne scars on my face and am willing to try a new treatment.I have an infection or an open wound in the area that needs treatment.I take medication that makes my skin more sensitive to sunlight.I have moles that could turn into skin cancer.I am not pregnant, using effective birth control, or planning to become pregnant during the study.I have taken Accutane or similar medication in the past 6 months.I am between 18 and 65 years old and in good health.I have had skin cancer or suspicious skin lesions in the area to be treated.I can attend all required visits for the trial.I am on medication that affects how my wounds heal.You have a history of keloid formation.You have very dark skin (type V or VI).I have a serious illness like lupus.You are currently participating in or have recently taken part in a trial for an experimental drug or device in the same area being studied, within the last 6 months.I have been treated with gold therapy.You have a medical condition or are in a situation that could put you at risk, make the study results unclear, or affect your ability to participate in the study.I have acne scars on my face and am willing to try a new treatment.I have not been exposed to the sun without protection or used tanning products in the last 4 weeks.You have epilepsy that is triggered by flashing lights.You are very sensitive to light in the near infrared range.You have a history of a weakened immune system or an autoimmune disease.I have a blood clotting disorder or I'm on blood thinners, including high-dose aspirin.A skin type V or VI is someone who has a very light skin color and is very sensitive to the sun.I can attend all required appointments.Agrees not to have any other procedures on the treatment area during the course of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Alexandrite Laser
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Acne Scars Patient Testimony for trial: Trial Name: NCT04807179 — N/A
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