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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects 18-65 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after the final treatment, optional 6 months after final treatment
Awards & highlights
MIRIA Trial Summary
This trial is testing a laser treatment for acne scars. Participants will get 4 treatments, 4-6 weeks apart, and results will be monitored after 1, 3 and possibly 6 months.
Who is the study for?
This trial is for individuals aged 18-65 with facial acne scars who can follow the study procedures and provide informed consent. Excluded are those with light-triggered seizure disorders, recent significant sun exposure, active infections or wounds on the face, skin cancer history in treatment area, recent use of certain skin treatments like retinoids or tanning products, ongoing participation in other clinical trials affecting the face, pregnancy or breastfeeding women without effective birth control.Check my eligibility
What is being tested?
The MIRIA Acne Scar Study tests the AVAVA MIRIA Laser Skin System's effectiveness on treating acne scars. Participants will undergo at least four laser treatments spaced 4-6 weeks apart. The improvement of their acne scars will be assessed after one month and could extend to three or six months post-treatment.See study design
What are the potential side effects?
Potential side effects from the MIRIA laser treatment may include temporary redness, swelling at the treatment site, increased sensitivity to sunlight, changes in pigmentation such as lightening or darkening of skin areas treated by the laser and a risk of triggering herpes simplex if previously affected.
MIRIA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
MIRIA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months after the final treatment, optional 6 months after final treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after the final treatment, optional 6 months after final treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement of Facial Acne Scars
MIRIA Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment with the MIRIA LaserExperimental Treatment1 Intervention
3-4 experimental treatments at 4-6 week intervals
Find a Location
Who is running the clinical trial?
AVAVA, Inc.Lead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You plan to lose more than five pounds.I do not have facial hair that could interfere with treatment assessments.I have seizures triggered by light.I have not been exposed to the sun without protection or used a tanning bed in the last four weeks.I do not have any infections, open wounds, or abscesses in the area being treated.I have had skin cancer or suspicious skin lesions in the area to be treated.I have used retinoid creams in the last 30 days.You have used tanning products in the four weeks before starting treatment.I have active acne or rosacea.I haven't had facial cosmetic procedures in the last 6 months.I am between 18 and 65 years old.I have not had micro-needling or chemical peels on the target area in the last 3 months.I am taking blood thinners or supplements like aspirin or fish oil.I am not pregnant, using effective birth control, and not planning to become pregnant during the study.You have had keloid scars in the past.I have taken Accutane or similar medication in the past 6 months.I have been treated with gold therapy.I have acne scars on my face.I haven't had cosmetic neurotoxin injections in the treatment area recently.I have a condition like vitiligo, psoriasis, or lichen planus that spreads with skin injury.I am taking medication that makes my skin more sensitive to sunlight.I have an immune system disorder or am taking medication that weakens my immune system.I am on medication that affects how my wounds heal.I do not have uncontrolled diabetes, high blood pressure, or heart disease.I do not have any major inflammatory diseases like lupus.I have had herpes simplex in the area to be treated.I have a history of skin color changes, like melasma or vitiligo.I have moles that could turn into skin cancer.You are very sensitive to light in the near infrared wavelength.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment with the MIRIA 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: NCT05597267 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate figure of participants for this research endeavor?
"Affirmative. According to the information hosted on clinicaltrials.gov, this investigation is in need of participants and began recruiting at the start of November 2022. The most recent update was made October 31st 2022 and 75 individuals are being sought from one medical facility."
Answered by AI
May I be accepted into this research endeavor?
"This medical trial is recruiting 75 participants with hypertrophy of ages 18-65. As a requirement for admission, all individuals must be able to provide informed consent and willing to undertake the necessary study protocols and home care treatments."
Answered by AI
Are older adults over the age of 70 excluded from participating in this clinical research?
"This trial is limited to persons aged 18 to 65. Those below the age of majority and above retirement have, respectively, 34 and 107 other clinical trials they can participate in."
Answered by AI
Is this experiment in progress and open to participants?
"As detailed on clinicaltrials.gov, recruitment for this medical trial is ongoing. The study was posted in November of 2022 and last edited on October 31st 2022."
Answered by AI
Who else is applying?
What state do they live in?
Nebraska
Maine
Alberta
What site did they apply to?
AVAVA, Inc.
Laser and Skin Surgery Center of New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
I’ve done two treatments and Botox, which made it worse. I’m willing to try anything.
PatientReceived 2+ prior treatments
I have tried countless creams, serums and peels with no result. I am willing to try anything.
PatientReceived 1 prior treatment
I have severe acne scars on my face, and hope this clinical trial will help to improve the skin condition.
PatientReceived 2+ prior treatments
I have tried so many different treatments over the years for my acne and scarring and nothing seems to work.
PatientReceived 1 prior treatment
I’m looking for options to improve my acne scars. I wondered if there were any cutting edge options being trialed right now and stumbled upon this during my search. Would love to join if eligible. My acne scars have been a source of stress.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long do the visits take and how soon are they going to conduct this? What are some precautions about the laser? Should I avoid the sun for a while?
PatientReceived 2+ prior treatments
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