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Laser Therapy
PicoWay Laser for Skin Rejuvenation
N/A
Waitlist Available
Research Sponsored by Candela Corporation
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 months
Awards & highlights
Study Summary
This trial will show whether the PicoWay Laser System is safe and effective for removing benign pigmented lesions and improving the appearance of wrinkles.
Who is the study for?
This trial is for adults over 18 with mild or greater benign pigmented lesions and/or wrinkles. Participants must follow post-treatment care, allow use of their treatment photos for educational purposes, and avoid other skin treatments during the study. Pregnant individuals or those with certain medical conditions like active infections or severe immunosuppression cannot join.Check my eligibility
What is being tested?
The PicoWay Laser System is being tested to see if it's safe and effective for getting rid of benign pigmented spots on the skin and improving the look of wrinkles. The trial will involve participants receiving laser treatments as per the study protocol.See study design
What are the potential side effects?
Potential side effects may include temporary redness, swelling at the treatment site, discomfort during application, risk of infection following treatment, changes in skin pigmentation, and rare chances of scarring.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Benign Pigmented Lesions (BPLs) and Global Aesthetic Improvement Score (GAIS)
Benign Pigmented Lesions (BPLs) and Pigment Improvement Score (PIS)
Wrinkles and Fitzpatrick Wrinkle and Elastosis Score 3 month follow up
+1 moreSecondary outcome measures
BPLs and Global Aesthetic Improvement Score (GAIS) 1 month follow up
BPLs and PIS 3 month follow up
Overall Subject Satisfaction 3 month follow up
+2 moreOther outcome measures
Evaluation Adverse Events
Trial Design
2Treatment groups
Experimental Treatment
Group I: WrinklesExperimental Treatment1 Intervention
Up to six (6) treatments with PicoWay laser for treatment of wrinkles
Group II: Benign Pigmented LesionsExperimental Treatment1 Intervention
Up to six (6) treatments with PicoWay laser for treatment of benign pigmented lesions
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Who is running the clinical trial?
Candela CorporationLead Sponsor
19 Previous Clinical Trials
1,915 Total Patients Enrolled
5 Trials studying Wrinkles
1,302 Patients Enrolled for Wrinkles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are willing to give informed consent to participate in the study.You are willing to comply with study treatment and follow-up schedule.You are willing to adhere to post-treatment care instructions.You are willing to comply with the study treatment protocol.If you have tattoos in the area where the treatment will be done, you must be willing to remove them before the treatment.You have a recent and noticeable tan in the area where the treatment will take place.You have a history of developing raised or thickened scars.You have a history of dark patches on the skin in the area where the treatment will be done, as determined by the person in charge of the study.You have a history of seizures triggered by light.You are at least 18 years of age.You have had vitiligo in the area where the treatment will be given.You have noticeable wrinkles or pigmented spots on your skin.
Research Study Groups:
This trial has the following groups:- Group 1: Benign Pigmented Lesions
- Group 2: Wrinkles
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies now open to prospective participants of this experiment?
"According to clinicaltrials.gov, enrollment for this particular trial has been closed since March 25th 2022—despite being first posted on September 28th 2020. Despite its lack of recruitment, there are still 22 other studies currently accepting patients."
Answered by AI
What objectives are being pursued through this research endeavor?
"According to Candela Corporation, primary outcomes that shall be monitored over a 12-month period include Benign Pigmented Lesions (BPLs) and the Patient Improvement Score (PIS). Furthermore, secondary objectives of this trial involve ascertaining Overall Subject Satisfaction 3 months after treatment as well as BPLS and Global Aesthetic Improvement Scores at 1 month follow up. The study also intends to gauge patient response via the PIG scale which scores from 0 - 4 where higher numbers connote more effective results."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
How old are they?
65+
What site did they apply to?
Candela Institute of Excellence
What portion of applicants met pre-screening criteria?
Met criteria
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