EUCTR2013-003241-42-DE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)
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 a study-specific ICF, which must be obtained in writing for all patients before any study procedures
- •Men or women =18 years of age (inclusive)
- •Presence of 1- 3 primary BCC lesions in face/forehead outside H-zone , bald scalp, extremities and/or neck/trunk, all of which are, according to clinical judgment of investigator, likely to fulfil criteria for positive outcome of histological assessment (non-aggressive BCCs comprising primary superficial, nodular, or mixed superficial/nodular BCC with a thickness =2 mm). Only eligible lesions with confirmation by biopsy taken at screening are allowed to be included in the study, lesions assessed as non-eligible should be excised by surgery or removed by cryotherapy in a timely manner. Other treatments are not allowed for these lesions.
- •To document and confirm investigator’s clinical diagnosis of non-aggressive behavior and thickness of the lesions, pre-study biopsies must be taken at the screening visit from all BCC lesions . 3-mm biopsies should be taken at the region of the tumor which, according to clinical judgment, appears thickest.
- •Biopsy material will be histopathologically evaluated by a dermatopathological expert according to WHO classification/subtyping. Ifno clear histopathological assessment can be performed second biopsy may be taken after approval of sponsor. Hence, time interval between Visit 1 / Visit 2 has to be expanded accordingly
- •The result of biopsies will ultimately determine whether the patient is eligible for the study; patient may only be enrolled if the investigator’s clinical diagnosis of non-aggressive BCC with a thickness of ely determine whether the patient ie lesion by the histopathological evaluation according to WHO classification guideline
- •The diameter of each lesion should range between =0.5 cm and =2 cm;total maximal treated area must not be larger than approximately 10 cm² (including a 0.5 – 1.0 cm margin surrounding each lesion).Size of each baseline BCC lesion is determined by measuring the two largest perpendicular diameters.To describe irregular lesions (ellipsoidal) the major and minor axes must be measured,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. Target lesions must be placed within max. 2 illumination areas (illumination area is defined by the effective illumination area of the BF-RhodoLED® device with approx. 6 x 16 cm)
- •Patients displaying non-eligible lesions by biopsy taken at screening should be included in the study if at least one lesion is eligible and non-eligible lesions are at least 10 cm apart from eligible lesion(s). The non-eligible lesions should timely be removed by surgery or cryotherapy.
- •Willingness to undergo biopsy at the end of the observer blind part of the study 12 weeks after 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 in the potential treatment area that may cause difficulty with examination or final evaluation
- •Willingness to stop use of moisturizers and any other topical treatments within the treatment area (during observer blind part), incl. anti-aging products, vitamin A-, vitamin D-, and/or vitamin E-containing ointments /creams, and green tea preparations during the study. Sunscreens will be allowed, but should not be applied in the tre
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)
- •Presence of more than 3 BCCs
- •Presence of malignant or benign tumors of skin other than non-aggressive BCC within treatment area (eg melanoma,SCC,aggressive BCC clearly diagnosed at screening visit by clinical assessment) within last 12 weeks
- •Treatment areas are defined as whole face (without H-zone) + forehead, bald scalp , neck, dorsal and back (neck/trunk) + extremities
- •Gorlin Syndrome or Xeroderma pigmentosum
- •Presence of photodermatoses
- •Recurrent or pigmented BCCs or clearly clinically diagnosed aggressive BCCs incl. morpheiform BCC
- •Treatment of lesions (AK,BCC,SCC,Bowens disease,melanoma) =12 weeks prior to first PDT, except physical treatments that will not be allowed =6 weeks prior to first PDT. Lesion(s) that seemed eligible by clinical judgment but could not be confirmed to be eligible by biopsy at screening, and which are located at a distance of =10 cm to an eligible lesion should be excised surgically or removed by cryotherapy in a timely manner. Such lesions must not be treated by PDT or topical medicaments during the observer blind part
- •Presence of lesion(s) which are assessed as non-eligible by biopsy at screening less than 10 cm away from a suitable lesion
- •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,valerian,or topically applied phototoxic substances ,within 8 weeks prior to screening. Patients may 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 observer blind part, such medication must not be newly prescribed. Should such a prescription become unavoidable for medical reasons during clinical part of the trial, investigator has to consult with 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 protocol or interpretation of 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 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 treatment area during observer blind part
- •Any topical treatment incl. diclofenac and immunomodulatory agents 12 weeks prior to first PDT session and during observer blind part
- •Any physical treatment during observer blind part within treated area(s) with the exception of lesion(s) that could not be confirmed to be eligible by biopsy at screening and which are located at a distance of =creening and which are loc
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