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Site for A randomized, double blind, vehicle-controlled, multicenter Phase II study to evaluate the safety and efficacy of BF-200 ALA (Ameluz) and BF-RhodoLED in the treatment of moderate to severe Acne vulgaris in adults with photodynamic therapy (PDT)
Moderate to Severe Acne Vulgaris: Males/Females 16 years and older. You will receive the study drug with either 1 hour or 3 hours between study drug application and illumination. The purpose of this study is to test the effectiveness and safety of the study drug, used at two different incubation times (time starting with administration of study drug until start of the red light illumination).
Amy Longenecker - at alongenecker@pennstatehealth.psu.edu or 717-531-5136
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NCT05080764
SITE00001055
Inclusion Criteria:
Ages 16 years and older may be eligible to participate. willingness to stop topical facial treatments other than medical cleansers at least 14 days prior to receiving investigational product.
For females must use an adequate and highly effective or two effective methods of contraception throughout the study. Study coordinator will discuss.
Exclusion Criteria:
History of soy or peanut allergy. For males- beard or other facial hair that might interfere with the study assessments unless subject agrees to be clean-shaven throughout the entire study period.
Certain medications/treatments not allowed during the study; study coordinator will discuss.
Skin Conditions