Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).

Inclusion Criteria:

• Willingness and ability to sign the informed consent form and Health InsurancePortability and Accountability Act (HIPAA) form. A study-specific informed consentform and a HIPAA form must be obtained in writing for all subjects prior to startingany study procedures.

• Men or women ≥18 years of age.

• Presence of ≥1 naïve sBCC lesion in the treatment areas face/forehead, bald scalp,extremities and/or neck/trunk, all of which are, according to the clinical judgementof the investigator, likely to be histologically confirmed as sBCCs. Lesions shouldnot be within the embryonic fusion planes (H-zone), especially within 2 cm of thehair zone or on the ears. In case of multiple lesions, one lesion is defined as MainTarget Lesion which will be excised at the end of the clinical observation period.Only eligible naïve sBCCs, confirmed by histology taken at screening, are allowed tobe included in the study as Main or Additional Target Lesions. Thus, eligible sBCCsmust lack any histological evidence of aggressive growth patterns (e.g. severesquamous metaplasia, infiltrative/desmoplastic features or basosquamous features).BCCs assessed as non-naïve (e.g. previously treated or recurrent) or non-eligible bybiopsy taken at screening (and in a distance >5 cm from the next lesion included inthe study) should be excised by surgery or removed by cryotherapy in a timelymanner. Other treatments for these lesions are not allowed during the study.

• The diameter of each eligible lesion should be ≥ 0.6 cm, and the entire treatmentfield must not exceed ~20 cm². The treatment field is defined as the field to whichIMP is applied, usually including the target lesions and margins surrounding thelesions of up to 1 cm. For the Main Target Lesion, the maximal lesion size should besuch that surgical excision without a skin transplant is feasible according to theinvestigator's judgement.

• Target BCC lesions must be discrete and located within 1-2 illumination areas (theillumination area is defined by the effective illumination area of the BF-RhodoLED®device with approximately 6 x 16 cm).

• Willingness to receive up to 4 PDTs within 3.5 months and excision of the MainTarget Lesion either at Visit 5, if clinically cleared, or at the end of theclinical observation period 12 weeks after the start of the last PDT cycle (Visit 8), irrespective of whether the treated Main Target Lesion was clinically cleared ornot.

• Free of significant physical abnormalities (e.g. tattoos, dermatoses) within thepotential treatment field plus a 5 cm radius surrounding the target lesion(s) asthey may interfere with examination or final evaluation.

• Willingness to stop the use of moisturizers and any other cosmetics within thetreatment field plus a 5 cm radius surrounding the target lesion(s) 48 hours priorto an office visit and 48 hours after each PDT session. Sunscreen will be allowed,but should not be applied to the treatment field plus the 5 cm radius surroundingthe target lesion(s) within approximately 24 h prior to a clinical visit.

• Acceptance to abstain from extensive sunbathing and the use of a solarium during theclinical observation period. Subjects with sunburn within treatment areas cannot beincluded until fully recovered.

• Healthy subjects and subjects with clinically stable medical conditions, including,but not limited to controlled hypertension, diabetes mellitus type II,hypercholesterolemia, and osteoarthritis, will be permitted to be included in thestudy if their medication is not prohibited by this protocol.

• Women of childbearing potential are permitted to participate in this study only ifthey have a negative serum pregnancy test at screening and are willing to use ahighly effective method of contraception during the clinical observation period ofthe study.

Exclusion Criteria:

• History of hypersensitivity to 5-ALA or any ingredient of BF-200 ALA which includessoybean phosphatidylcholine.

• Hypersensitivity to porphyrins.

• Current treatment with immunosuppression therapy.

• Presence of photodermatoses.

• Presence of porphyria.

• Presence of clinically significant inherited or acquired coagulation defect.

• Evidence of clinically significant (CS) unstable medical conditions, such as:

• Metastatic tumor or tumor with high probability of metastasis.

• Cardiovascular disease class III, IV (New York Heart Association [NYHA]).

• Immunosuppressive condition.

• Hematologic, hepatic, renal, neurologic, or endocrine condition.

• Collagen-vascular condition.

• Gastrointestinal condition.

• Clinically relevant cardiovascular, hepatic, renal, neurologic, endocrine, or othermajor systemic diseases that complicate implementation of the protocol orinterpretation of the study results.

• Gorlin Syndrome or Xeroderma pigmentosum.

• Presence and/or physical treatment of skin tumors other than (naïve) sBCC (e.g.malignant melanoma, squamous cell carcinoma (SCC), Bowen's disease, aggressive BCCor nBCC diagnosed at the screening visit by clinical assessment) within a distanceof ≤ 5 cm from the nearest target lesion within 4 weeks prior to PDT (Visit 2) untilthe end of the clinical observation period. However, biopsied lesion(s) that werenot confirmed eligible at screening and which are located at a distance of > 5 cmfrom any lesion(s) that will be included in the study can be surgically removed.Treatment by PDT or topical medication during the course of the clinical observationperiod of the study triggers exclusion of the subject.

• If lesion(s) are assessed as non-eligible by biopsy during initial screening andthese lesions are localized within a distance of 5 cm from an otherwise suitablelesion, this suitable lesion must be excluded from the study.

• Αny AK lesions within the treatment field (lesion area including margin of 0.5 to 1.0 cm).

• Any topical medical treatment of AK, other non-melanoma skin cancers (NMSC), ormelanoma (except for IMP treatment of the target lesion(s)) starting 12 weeks priorto Visit 2 (PDT-1) and lasting until the end of the clinical observation period.

• Any other topical medical treatment of the skin 12 weeks prior to Visit 2 (PDT-1)until the end of the clinical observation period, with the exception of:

• Topical treatments with corticosteroids (allowed throughout the clinicalobservation period of the study).

• Topical non-steroidal anti-inflammatory drugs (NSAIDs such as diclofenac) (allowed throughout the clinical observation period of the study with therestriction of 7 days prior to and 7 days after PDTs).

• Start of intake of medication with hypericin or systemically acting drugs withphototoxic or photoallergic potential within 8 weeks prior to screening.

• Any of the systemic treatments listed below, within the designated period prior toPDT and during the clinical observation period.

• Interferon - 6 weeks

• Immunomodulators or immunosuppressive therapies - 12 weeks

• Cytotoxic drugs - 6 months

• Investigational drugs - 8 weeks

• Drugs known to have major organ toxicity - 8 weeks

• Corticosteroids (oral or injectable) - 6 weeks

• MAL or ALA - 12 weeks

• Systemic treatment with NSAIDs is not to be used 7 days prior to and 7 days afterPDT. ASA (e.g. Aspirin®) up to 100 mg/ day, ibuprofen up to 200 mg/ day, andacetaminophen (e.g. Tylenol®) is allowed during this period.

• Presence of tattoos, skin inflammation, wounds, etc. in the treatment field(s) plusa 5 cm radius surrounding the target lesion(s).