Phase
Condition
N/ATreatment
Hemopfin+Green Light
Vehicle+Green Light
Vehicle+PDT
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject must be 18 to 65 years of age inclusive, at the time of signing the informedconsent.
Subject is Fitzpatrick skin type I-VI.
A male subject must agree to use contraception during the Treatment Period and forat least 6 months after the last dose of study treatment and refrain from donatingsperm during this period.
A female subject is eligible to participate if she is not pregnant, notbreastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) . OR A WOCBP who agrees to follow thecontraceptive guidance during the Treatment Period and for at least 30 days afterthe last dose of study treatment.
The subject has a clinical diagnosis of PWB located on the face and/or neck.
The longest diameter of the treatment area is ≥3 cm, and the short diameter is ≥2cm.
Subject is capable of giving signed informed consent, which includes compliance withthe requirements and restrictions listed in the informed consent form (ICF) and inthis protocol.
Subject, in the Investigator's opinion, is in good general health and free of anydisease state or physical condition that may impair the evaluation of PWB or exposethe subject to an unacceptable risk by study participation.
Exclusion
Exclusion Criteria:
Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject has plaque/nodular changes and severe hypertrophy within the target PWBarea.
Subject has Sturge-Weber syndrome or PWB involving ophthalmic nerves.
Subject has any skin pathology or condition that, in the Investigator's opinion,could interfere with the evaluation of the study drug or requires use of interferingtopical, systemic, or surgical therapy.
Subject is immunosuppressed related to medication use and/or disease.
Subject has clinically significant ECG abnormalities at Screening
Subject has clinically significant laboratory abnormalities as assessed by theInvestigator at Screening.
Subject has received any therapy on the treatment region that, in the Investigator'sopinion, may affect the target PWB area.
Subject is currently enrolled in an investigational drug or device study, includingclinical studies in dermatology.
Subject has used an investigational drug or investigational device treatment within 30 days prior to C1D1.
Subject is known or in the opinion of the Investigator likely to be noncompliantwith the requirements of the study protocol (eg, due to alcoholism, drug dependency,mental incapacity).
Subject has a history of either significant neurological events (such as majorstroke) or a mental condition rendering him/her unable to understand the nature,scope, and possible consequences of the study.
Subject has an unstable cardiac disease or has any medical condition that in theopinion of the Investigator may worsen from receipt of study treatment or subjectparticipation.
Study Design
Study Description
Connect with a study center
UCI Health Beckman Laser Institute & Medical Clinic
Irvine, California 92697
United StatesSite Not Available
Dermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research Center
San Diego, California 92121
United StatesActive - Recruiting
Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE)
Aventura, Florida 33180
United StatesActive - Recruiting
Miami Dermatology and Laser Institute
Miami, Florida 33173
United StatesActive - Recruiting
Maryland Dermatology, Laser, Skin & Vein Institute
Hunt Valley, Maryland 21030
United StatesActive - Recruiting
St. Luke's University Health Network
Bethlehem, Pennsylvania 18015
United StatesSite Not Available
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