Phase
Condition
Brain Tumor
Warts
Treatment
GentleMax Pro (without skin cooling)
GentleMax Pro (with skin cooling)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant is an adult ≥18 years of age.
Participant has a diagnosis of NF1 based on germline genetic testing or by meeting ≥ 2 the following criteria:
Family history of NF1
Six or more light brown ("cafe-au-lait") spots on the skin
Presence of two or more neurofibromas of any type, or one or more plexiformneurofibromas
Freckling under the arms or in the groin area
Two or more pigmented, benign bumps on the eye's iris (Lisch nodules)
A distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone behindthe eye, or dysplasia of long bones, often in the lower leg
Tumor on the optic nerve that may interfere with vision
Participant is seeking treatment for cNF.
Participants must have ≥ 12 paired cNF (6 to be treated without DCD, 6 to be treatedwith DCD) that are visible and measure at least 2 mm in size in the target treatmentarea. The target treatment area must be amenable to both laser treatments andsurveillance with digital and 3D photography. Preferred locations are trunk (back orchest), arms and legs.
Participant is able and willing to comply with all visit, treatment, and evaluationschedules and requirements.
Participant is able to understand and provide written informed consent.
Participant has no concurrent injury or wound in the target area.
Exclusion
Exclusion Criteria:
Participant cannot give informed consent or adhere to study schedule.
Participant is Fitzpatrick skin type V-VI.
Participant is actively tanning during the course of the study.
For female participants: participant is pregnant.
Participant has any condition which, in the Investigator's opinion, would make itunsafe (for the participant or study personnel) to treat the participant as part ofthis research study.
Study Design
Connect with a study center
Wellman Center for Photomedicine, Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available

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