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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Agreement to not undergo any other procedure(s) or add any new treatment modalities in the target area during the study
Clinically diagnosed acne vulgaris of moderate to severe on each hemiface and inflammatory acne lesions as determined by the blinded trained investigator using the Investigator's Global Assessment Scale
Must not have
Clinically diagnosed acne vulgaris of severity grade of clear, almost clear, or mild on at least one hemiface as determined by the blinded trained investigator using the Investigator's Global Assessment Scale
History of radiation to the target area, currently undergoing treatment for skin cancer in the target area or undergoing systemic chemotherapy for the treatment of cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial is testing whether a laser can effectively and safely treat acne vulgaris.
Who is the study for?
This trial is for individuals aged 16-50 with moderate to severe acne vulgaris on both sides of the face. Participants must have a range of skin types, avoid sun exposure and new acne treatments during the study, and be willing to stop using current acne medications for specified periods before and during the trial.
What is being tested?
The study tests a laser treatment (1726nm Laser System) against a sham (fake) laser to see how well it works in treating acne vulgaris. It looks at how quickly it starts working, how long effects last, its overall effectiveness, and safety.
What are the potential side effects?
While not explicitly listed here, potential side effects may include skin irritation or redness from the laser treatment. There could also be risks associated with light sensitivity due to either underlying conditions or medications that increase light sensitivity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree not to have any other treatments in the target area during the study.
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I have moderate to severe acne on both sides of my face.
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I am between 16 and 50 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with mild to almost clear acne on one side of my face.
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I have had radiation or am being treated for skin cancer or receiving chemotherapy.
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I haven't been part of a clinical trial for a drug or device targeting the same area in the last month.
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I have been diagnosed with a pigment disorder in the area of interest.
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I haven't had injections like collagen in the target area within the last 2 weeks.
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I have a blood clotting disorder or am on blood thinners.
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I have an immune system disorder or am taking medication that weakens my immune system.
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I do not have skin conditions in the acne area that could affect its assessment.
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I haven't had botulinum toxin injections in the target area within the last month and won't during the study.
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I have had cancer in the area being targeted for treatment.
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I have been diagnosed with a connective tissue disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1726nm Laser TreatmentExperimental Treatment1 Intervention
Group II: Sham Laser TreatmentPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
ethica Clinical Research Inc.Industry Sponsor
19 Previous Clinical Trials
1,800 Total Patients Enrolled
Cutera Inc.Lead Sponsor
43 Previous Clinical Trials
1,156 Total Patients Enrolled
1 Trials studying Acne
4 Patients Enrolled for Acne
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with mild to almost clear acne on one side of my face.I have had radiation or am being treated for skin cancer or receiving chemotherapy.I haven't had any treatments on the target area in the last month.I haven't been part of a clinical trial for a drug or device targeting the same area in the last month.I have been diagnosed with a pigment disorder in the area of interest.I agree to limit my sun exposure and use SPF 30+ sunscreen daily during the study.I agree not to have any other treatments in the target area during the study.People with any type of skin color can participate.I haven't had injections like collagen in the target area within the last 2 weeks.I haven't taken any retinoid medication like isotretinoin in the last 6 months.I have a blood clotting disorder or am on blood thinners.I have an immune system disorder or am taking medication that weakens my immune system.I do not have excessive facial hair or adornments that could interfere with treatment on my face.I have moderate to severe acne on both sides of my face.I do not have skin conditions in the acne area that could affect its assessment.I am between 16 and 50 years old.I haven't had botulinum toxin injections in the target area within the last month and won't during the study.I can follow the treatment plan and care instructions.I have had cancer in the area being targeted for treatment.I am taking medication that makes my skin more sensitive to light.You have had a bad reaction to Pro-Nox or a similar medication in the past.You have a history of a condition in the target area that gets worse with heat, unless you are taking preventive treatment.I am willing to stop using acne treatments on my face for 2 weeks and any oral acne medication for 1 month before the study starts.I have been diagnosed with a connective tissue disease.
Research Study Groups:
This trial has the following groups:- Group 1: 1726nm Laser Treatment
- Group 2: Sham Laser Treatment
Awards:
This trial has 0 awards, including: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.
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