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.
Condition or Disease
|Estimated Enrollment:||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Vehicle-controlled, Multicenter Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using the BF-RhodoLED® XL or BF-RhodoLED® Lamp|
|Actual Study Start Date:||December 12, 2022|
|Estimated Primary Completion Date:||July 2024|
|Estimated Study Completion Date:||April 2025|
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Willingness and ability of subjects to provide informed consent and sign the Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent and HIPAA form must be obtained in writing prior to starting any study procedures.
- 4 – 15 mild to moderate clinically confirmed AK lesions according to Olsen either on the extremities or on the neck/trunk with a diameter of ≥ 4 mm that must be present in the treatment field (defined as AK target lesions). In addition, non-target AK lesions may be present in the treatment field, including up to two severe AK lesions ≥ 4 mm. For each severe AK lesion (≥ 4 mm), a biopsy must be taken for confirmation of diagnosis. The treatment field (continuous or in several patches) totaling approx. either 80 cm², 160 cm² or 240 cm2 must be within one effective illumination area of the BF-RhodoLED® XL but may require up to three illuminations with the BF-RhodoLED®. All AK target lesions and, if applicable, severe AK lesions ≥ 4 mm located in the treatment field should be clearly distinguishable, without restrictions on the distance between lesions, and should have a minimal distance of 1 cm to the border of the treatment field.
- All sexes, ≥ 18 years of age.
- Willingness to undergo a 2 mm punch biopsy for each (up to two) severe AK lesion ≥ 4 mm, if applicable, at the screening visit.
- Willingness and ability to comply with study procedures, particularly willingness to receive up to 2 PDTs within approximately 12 weeks.
- Subjects with good general health or with clinically stable medical conditions will be permitted to be included in the study.
- Willingness to stop the use of moisturizers and any other non-medical topical treatments within the treatment field at least 24 h prior to the next clinical visit.
- Acceptance to abstain from extensive sunbathing and the use of a solarium or tanning beds during the treatment phase.
- For female subjects with reproductive potential: Negative serum pregnancy test.
- For female subjects with reproductive potential: Effective contraception at screening visit and throughout the treatment phase of the study (until Visit 4 or Visit 6).
- 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:
- Presence of photodermatoses or porphyria
- Metastatic tumor or tumor with high probability of metastasis
- Infiltrating skin neoplasia (suspected or known)
- Unstable cardiovascular disease (New York Heart Association class III, IV)
- Unstable hematologic (including myelodysplastic syndrome), hepatic, renal, neurologic, or endocrine condition
- Unstable collagen-vascular condition
- Unstable gastrointestinal condition
- Immunosuppressive condition
- Presence of clinically significant inherited or acquired coagulation defect
- 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:
- Topical treatment with ALA or ALA esters (e.g., methyl aminolevulinic acid (MAL)) inside the treatment field within 3 months.
- Topical treatment with immunomodulatory, cytostatic, or cytotoxic drugs inside or in close proximity (< 10 cm distance) to the treatment field within 3 months.
- Start of topical administration of a medication with hypericin or other drugs with phototoxic or photoallergic potential inside or in close proximity (< 10 cm distance) to the treatment field within 4 weeks. Subjects may, however, be eligible if such medication was applied for more than 4 weeks prior to screening without evidence of an actual phototoxic/photoallergic reaction.
- Any use of the systemic treatments within the designated periods prior to screening:
- Cytostatic or cytotoxic drugs within 6 months.
- Immunosuppressive therapies or ALA or ALA esters (e.g., MAL) within 12 weeks.
- Drugs known to have major organ toxicity within 8 weeks.
- Interferon or glucocorticosteroids within 6 weeks.
- Start of intake of medication with hypericin or drugs with phototoxic or photoallergic potential within 8 weeks prior to screening. Subjects may, however, be eligible if such medication was taken in for more than 8 weeks prior to the screening visit without evidence of an actual phototoxic/photoallergic reaction.
- 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.