Cosmetic Laser Dermatology | San Diego, CA
Status and phase
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About
The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) for the medication Ameluz® performed with the PDT-lamp BF-RhodoLED® in comparison to the respective placebo treatment for moderate to severe Acne vulgaris.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
Any known history of hypersensitivity to ALA, porphyrins or excipients of BF-200 ALA.
History of soy or peanut allergy.
Subjects with sunburn or other possible confounding skin conditions (e.g. wounds, irritations, bleeding or skin infections) within or in close proximity (< 5 cm distance) to treatment field. (Reassessment of subjects is allowed once if the sunburn or other confounding skin conditions is/are expected to resolve within the screening period.
Reassessment can be done on the day of the actual treatment.)
Clinical diagnosis of atopic dermatitis and other cutaneous conditions (e.g. lupus erythematosus), Bowen's disease, BCC, eczema, psoriasis, acne conglobate, acne fulminans, or secondary acne (steroid-induced acne, perioral dermatitis, acne rosacea), squamous cell carcinoma, other malignant or benign tumors in the treatment field.
Clinically significant (CS) medical conditions making implementation of the protocol or interpretation of the study results difficult or impairing subject's safety such as:
Beard or other facial hair that might interfere with the study assessments unless subject agrees to be clean-shaven throughout the entire study period. (Reassessment of subjects is allowed once if assessment of acne lesions is impaired by facial hair at screening. Reassessment can be performed on the day of the actual treatment).
Facial procedures such as dermabrasion, chemical or laser peels as well as exposure to UV radiation (other than sunlight) at least 4 weeks prior to randomization visit (Visit 2, baseline).
Presence of strong artificial pigmentation (e.g. tattoos) or any other abnormality that may impact lesion assessment or light penetration in the treatment field.
Suspicion of drug or alcohol abuse.
Any topical medication of the skin prior to screening as defined below:
Any use of the below specified systemic treatments within the designated periods:
Breast feeding women.
Subject unlikely to comply with protocol, e.g. inability to return for visits, unlikely to complete the study, or inappropriate in the opinion of the investigator.
Prior randomization in the study.
A member of study site staff or sponsor staff directly involved in the conduct of the protocol or a close relative thereof.
Simultaneous participation in a further clinical study.
Four or more nodular acne lesions on the face.
Unwillingness or inability to limit sun exposure for 48 hours post PDT treatment.
Dosing Day exclusion criteria:
Primary purpose
Allocation
Interventional model
Masking
126 participants in 4 patient groups, including a placebo group
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Central trial contact
Audrey Steinecke, Dr
Data sourced from clinicaltrials.gov
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