Phase
Condition
N/ATreatment
532 nm laser treatment
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
.Subject must be able to read, understand and sign the Informed Consent Form. 2.Female or Male, 18 to 75 years of age (inclusive). 3. Fitzpatrick Skin Type I - VI.
Have non-facial port wine stain covering at least 30cm2 area on the body. 5. Mustbe willing to have Lutronic DermaV treatments (532 nm) and able to adhere to thetreatments, follow-up visit schedule, and post-treatment care instructions.
Willing to have very limited sun exposure and use sunscreen on the treatment area every day for the duration of the study, including the follow-up period.
Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation (educational and/or marketing), publications, and any additional marketing purposes.
Agree to not undergo any other cosmetic procedure(s) or treatment(s) on the treated areas during the study and has no intention of having such procedures performed during the course of the study.
For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.,
Exclusion
Exclusion Criteria:
Participation in a clinical trial of another drug, or device administered to thetreatment area, within 3 months prior to enrollment or during the study.
Any type of prior cosmetic or port wine stain treatment to the target area within 3months of study participation.
Suffering from significant skin conditions in the treated areas or inflammatory skinconditions, including but not limited to, open lacerations or abrasions,hidradenitis, rash, infection , or dermatitis of the treatment area prior totreatment (duration of resolution as per the Investigator's discretion).
Pregnant and/or breastfeeding, or planning to become pregnant.
Significant concurrent illness, such as diabetes mellitus, immunosuppression/immunedeficiency disorders (including HIV infection or AIDS) or using immunosuppressivemedication.
Hypersensitivity to light exposure.
Any use of medication that is known to increase sensitivity to light according tothe Investigator's discretion.
History of keloid scarring, hypertrophic scarring or abnormal wound healing or proneto bruising.
Has a history of squamous cell carcinoma or melanoma in the treatment area.
History of epidermal or dermal disorders (particularly if involving collagen ormicrovascularity), including collagen vascular disease or vasculitic disorders.
A history or active skin condition that in the opinion of the Investigator mayinterfere/confound with the treatment.
History of connective tissue disease, such as systemic lupus erythematosus orscleroderma.
History of disease stimulated by heat, such as recurrent herpes simplex and/orherpes zoster (shingles) in the treatment area, unless treatment is conductedfollowing a prophylactic regimen.
History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation, or any that are considered not acceptable by the study investigator.
Excessively tanned or active sun tan in area to be treated, or unable/unlikely torefrain from tanning during the study.
Excessive hair in the area to be treated (beards, sideburns, and/or moustache,) thatwould interfere with diagnosis, assessment, and treatment.
As per the Investigator's discretion, any physical or mental condition which mightmake it unsafe for the subject to participate in this study, including excessivealcohol or drug abuses, or a condition that would compromise the subject's abilityto comply with the study requirements.
Study Design
Connect with a study center
Wellman Center for Photomedicine, Harvard Medical School
Boston, Massachusetts 02114
United StatesSite Not Available
Wellman Center for Photomedicine, Harvard Medical School
Boston 4930956, Massachusetts 6254926 02114
United StatesActive - Recruiting

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