EUCTR2013-003241-42-GB进行中（未招募）1 期
A randomized, observer blind, multinational phase III study to evaluate the safety and efficacy of BF-200 ALA (Ameluz®) in comparison to Metvix® in the treatment of non-aggressive basal cell carcinoma (BCC) with photodynamic therapy (PDT) - ALA-BCC-CT008
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 394
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Willing and able to sign the informed consent form. A study-specific informed consent must be obtained in writing for all patients before any study procedures.
- •Men or women =18 years of age (inclusive).
- •Presence of 1 to 3 thin (=2 mm thickness), non-aggressive, primary BCC lesions (comprising primary superficial, nodular, or mixed superficial/nodular) in the face/forehead outside the H-zone (see Appendix B), bald scalp, extremities and/or neck/trunk. Confirmation of non-aggressiveness and thickness of BCC through biopsies of all lesions taken at screening.
- •To document and confirm the investigator’s clinical diagnosis of non-aggressive behavior of the lesions:
- •Pre-study biopsies must be taken from all BCC lesions at the screening visit (Visit 1). Investigators are requested to take the 3 mm biopsy at the region of the tumor which, according to clinical judgment, appears thickest.
- •- The biopsy material will be histopathologically evaluated by a dermatopathological expert according to the WHO classification/subtyping(2). In case no clear histopathological assessment can be performed a second biopsy may be taken after approval of the sponsor. Hence, the time interval between Visit 1 and Visit 2 has to be expanded accordingly.
- •The result of the biopsies will ultimately determine whether the patient is eligible for the study; the patient may only be enrolled if the investigator’s clinical diagnosis of non-aggressive BCC is confirmed for all lesions by the histopathological evaluation according to WHO classification guideline(2) and the lesion thickness is =2 mm.
- •The diameter of each lesion should range between =0.5 cm and =2 cm; the total maximal treated area must be not larger than approximately 10 cm² (including a 0.5 – 1.0 cm margin surrounding each lesion). The maximal thickness of a lesion should not exceed 2 mm (by means of histopathological confirmation).
- •The size of each baseline BCC lesion is determined by measuring the two largest perpendicular diameters. To describe irregular lesions (ellipsoidal), investigators must measure the major and minor axes, which must both be within the acceptable limits defined above.
- •Target BCC lesions must be discrete and quantifiable and have to be located within 1 to 2 treatment areas.
- •Willingness to undergo biopsy at the end-of-study visit 12 weeks after the last PDT in case of partial or non-responding lesions.
- •Willingness to receive up to 4 PDTs within 3.5 months.
- •Free of significant physical abnormalities (eg tattoos, dermatoses) in the potential treatment area that may cause difficulty with examination or final evaluation.
- •Willingness to stop the use of moisturizers and any other topical treatments within the treatment area (during the observer blind part of the study), including anti-aging products, vitamin A-, vitamin D-, and/or vitamin E-containing ointments and creams, and green tea preparations during the study. Sunscreens will be allowed, but should not be applied in the treatment area within approximately 24 h before a clinical visit that involves a lesion count.
- •Accept to abstain from extensive sunbathing and use of a solarium during the observer blind part of the study. Patients with sunburn within the treatment areas cannot be included until fully recovered.
- •Healthy patients or patients with clinically stable medical conditions as confirmed by physical examination and by medical history, including but not limited to controlled hypertension, diabetes mellitus t
排除标准
- •History of hypersensitivity to 5-ALA or any ingredient of BF-200 ALA.
- •History of hypersensitivity to MAL or any ingredient of Metvix® cream including arachis oil, or to peanut or soya.
- •Current treatment with immunosuppression therapy.
- •Presence of porphyria.
- •Hypersensitivity to porphyrins.
- •Presence of BCC lesions on embryonic fusion planes (H-zone, see Appendix B).
- •Presence of more than 3 BCCs.
- •Presence of malignant or benign tumors or precancerous lesions of the skin other than non-aggressive BCC within the treatment area (eg malignant melanoma, squamous cell carcinoma (SCC)) within the last 12 weeks.
- •Gorlin Syndrome or Xeroderma pigmentosum.
- •Presence of photodermatoses.
- •Confirmed histopathological diagnosis of other than non-aggressive BCC.
- •Treatment of recurrent BCCs, pigmented or aggressive BCCs including morpheiform BCC.
- •Treatment of lesions (AK, BCC, SCC, Bowens disease, melanoma) =12 weeks prior to first PDT, except physical treatments (eg cryosurgery, excision surgery) that will not be allowed =4 weeks prior to screening visit (Visit 1).
- •Presence of inherited or acquired coagulation defect.
- •Start of intake of medication with hypericin or systemically-acting drugs with phototoxic or photoallergic potential, such as psoralenes, tetracyclines, nalidixic acid, furosemide, amiodarone, phenothiacines, chinolones, fibrates, or phytotherapy with St. John’s wort, arnica, or valerian, or topically applied phototoxic substances like tar, pitch, psoralenes or some dyes like thiazide, methylene blue, toluidine blue, eosine, Bengal rose, or Acridine within 8 weeks prior to screening. Patients may, however, be enrolled if such medication was taken for more than 8 weeks prior to screening without evidence of a phototoxic/photoallergic reaction. Within 8 weeks prior to screening and during the observer-blind part of the study, such medication must not be newly prescribed. Should such a prescription become unavoidable for medical reasons during the clinical part of the trial, the investigator has to consult with the sponsor, who may discontinue the patient’s study participation, if deemed necessary.
- •Clinically relevant cardiovascular, hepatic, renal, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult.
- •Evidence of clinically significant (CS), unstable medical conditions, such as:
- •- Metastatic tumor or tumor with high probability of metastatic spread.
- •- Cardiovascular disease (New York Heart Association (NYHA) class III, IV).
- •- Immunosuppressive condition.
- •- Hematologic, hepatic, renal, neurologic, or endocrine condition.
- •- Collagen-vascular condition.
- •- Gastrointestinal condition.
- •Topical treatment with 5-ALA or MAL outside the treatment area during the observer blind part of the study.
- •Any topical treatment including diclofenac and immunomodulatory agents (eg imiquimod, ingenol mebutate) 12 weeks prior to the first PDT session and during the observer blind part of the study.
- •Any physical treatment during the observer blind part of the study within the treated target areas.
- •None of the following systemic treatments within the designated period prior to the first PDT session and during the observer blind part of the study:
- •- Interferon (6 weeks)
- •- Immunomodulators or immunosuppressive therapies (10 weeks)
- •- Cytotoxic drugs (6 months)
- •- Investigational drugs (8 weeks)
- •- Drugs known to have major organ toxicity (8 we
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