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Laser
GentleMax Pro Plus for Nail Fungus
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 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the GentleMax Pro Plus™ laser for safety and effectiveness in treating unwanted hair, skin discolorations, nail fungus, wrinkles, and acne. The laser works by using light to target and treat these specific issues. The GentleMax Pro Plus™ laser is part of a broader category of laser and light-based devices that have been widely used for various dermatological treatments, including hair removal, skin discolorations, and acne.
Eligible Conditions
- Nail Fungus
- Acne
- Fungal Nail Infection
- Razor Bumps
- Hirsutism
- Pigmented Lesions
- Vascular Lesions
- Wrinkles
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acne Counts
Fitzpatrick Wrinkle and Elastosis Score
Global Aesthetic Improvement Score
+4 moreSecondary study objectives
Subject Global Aesthetic Improvement Score
Subject Pain
Subject Satisfaction Score
Awards & 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: Treatment ArmExperimental Treatment1 Intervention
All study subjects are to receive treatment with GentleMax Pro Plus device. Subjects will be scheduled to receive as little as one (1) and up to eight (8) treatments with the GentleMax Pro Plus™ Laser System. Up to 2 follow-ups will occur.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GentleMax Pro Plus
2020
N/A
~80
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Who is running the clinical trial?
Candela CorporationLead Sponsor
20 Previous Clinical Trials
2,038 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical history of vitiligo in the area where treatment is planned.You have blonde, grey, or white hair and want to have it removed for the study.You have a recent and noticeable tan in the area where you are supposed to receive the treatment.You have tattoos in the area where you will receive the treatment.You have a history of developing raised, thickened scars called keloids or hypertrophic scars.You have visible hair, pigmented spots, acne, spider veins, fungal nail infection, or wrinkles that are considered moderate or severe according to the Fitzpatrick Wrinkle and Elastosis Score.You have a history of skin condition called melasma in the area where the treatment is supposed to be given.You have a medical history of seizures triggered by light.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
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.
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