Clinical Research Center of the Carolinas | Charleston, SC
Status and phase
Conditions
Treatments
About
The aim of this study is to test the safety. tolerability and efficacy of field-directed photodynamic therapy (PDT) with 10% aminolevulinic acid gel (Ameluz®, BF-200 ALA) in combination with one of the narrow spectrum red light RhodoLED lamps in comparison to vehicle treatment for actinic keratosis (AK) on the extremities and neck/trunk.
Enrollment
Sex
Ages
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.
Sunburn or other possible confounding skin conditions (e.g., wounds, irritations, bleeding, or skin infections) inside or in close proximity (< 2 cm distance) to 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:
Clinical diagnosis of atopic dermatitis, Bowen´s disease (BD), basal cell carcinoma (BCC), eczema, psoriasis, rosacea, squamous cell carcinoma (SCC), other malignant or benign tumors inside or in close proximity (< 2 cm distance) to the treatment field.
Presence of strong artificial pigmentation (e.g., tattoos) or any other abnormality that may impact lesion assessment or light penetration in the treatment field.
Any physical therapy such as cryotherapy, laser therapy, electrodessication, microdermabrasion, surgical removal of lesions, curettage, or treatment with chemical peels such as trichloroacetic acid inside or in close proximity (< 10 cm distance) to the treatment field within 4 weeks prior to screening.
Any of the topical treatments defined below within the designated periods prior to screening:
Any use of the systemic treatments within the designated periods prior to screening:
Breast feeding women.
Suspicion of drug or alcohol abuse.
Subjects 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.
A member of study site staff or sponsor staff directly involved in the conduct of the protocol or a close relative thereof.
Receipt of any investigational drug or medical product within 8 weeks before screening or simultaneous participation in another clinical study.
Reassessment of subjects is allowed once in case exclusion criterion 3 is met and eligibility can be achieved within 4 weeks. Reassessment can be done on the day of the actual treatment.
Dosing day exclusion criteria:
At Visit 2 (baseline, PDT-1)
Subjects with sunburn or other possibly confounding skin conditions (e.g., wounds, irritations, bleeding, or skin infections) inside or in close proximity (< 2 cm distance) to the treatment field. Reassessment of subjects is allowed once if the sunburn or other confounding skin conditions is/are expected to resolve within 2 weeks.
At Visit 4 (PDT-2)
Subjects with sunburn or other possibly confounding skin conditions (e.g., wounds, irritations, bleeding, or skin infections) inside or in close proximity (< 2 cm distance) to the treatment field. Rescheduling of PDT-2 can be performed once at the earliest possibility after resolution, but rescheduling should not exceed 2 weeks.
Primary purpose
Allocation
Interventional model
Masking
165 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
Corinna Zogel, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal