EUCTR2008-001603-30-GB进行中（未招募）1 期
Gene expression in renal transplant patients with field Actinic Keratosis undergoing Metvix® PDT - Metvix® PDT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Galderma R&D
- 入组人数
- 10
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
入选标准
- •- Renal transplant male or female subject, aged at least 18 years old, with an history of immunosuppression from 5 to 15 years,
- •- Subject presenting field of mild or moderate AKs with at least 4 discrete mild or moderate AK lesions on the face, scalp, forearms or chest ,
- •- Female of child-bearing potential with negative urinary pregnancy test at the beginning of the study and who practices a highly effective method of contraception all along the study and female of non childbearing potential,
- •- Subject able to follow study instructions and likely to complete all required visits.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Female subject who is pregnant, or of child-bearing potential and wishing to become pregnant during the study, or is breast feeding,
- •- Subject who is at risk in terms of precautions, warnings, and contra-indication referred in the package insert of Metvix®,
- •- Subject with thick AK lesions on the target field,
- •- Subjects with pigmented AK(s) on the target field,
- •- Subject with AK lesions clinically atypical or suspicious for malignancy on the target field,
- •- Subject presenting other skin lesions (including non melanoma skin cancers) on the target field,
- •- Subject with suspected porphyria,
- •- Subject with a bad skin condition (eczema, rosacea, acne, atopic dermatitis, psoriasis…) in the target field or who is in a situation which, in the investigator’s opinion , may put the subject at risk, may confound the study results, or may interfere with the subject’s participation in the study,
- •- Subject who has been treated in the target field with any of the following topical treatments within the specified washout period at Screening:
- •. 5-FU, Imiquimod, Diclofenac sodium: 3 months
- •. Cryotherapy: 3 months
- •. PDT: 3 months
- •. Other less common AK treatments: 3 months
- •- Subject who has been treated with systemic retinoids within the last month prior to Screening visit,
- •- Subject with known HIV or chronic hepatitis B and/or C (To be confirmed based on previous blood analysis done at a maximum within 3 months prior to the Screening visit or, if not available will be confirmed at Baseline with blood sample results performed at Screening),
- •- Subject who has participated in another investigational drug or device research study within 30 days of enrolment (screening visit),
- •- Subject requiring concurrent treatment that would interfere with study objectives and/or evaluations,
- •- Adult protected by the law (adult under guardianship, or hospitalised in a public or private institution for a reason other than the study, or subject deprived of freedom),
- •- Subject who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...).
研究者
相似试验
已完成
4 期
Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)Actinic KeratosisNCT01000636Galderma R&D9
已完成
不适用
Whole cytoplasmic replacement at zygote stage (day 1 embryo) for the treatment of infertilityISRCTN58459168adiya Clinic29
Unknown
不适用
Analysis of Biopsies With Antibody Mediated Rejection According to the Therapy ResponseAntibody-mediated RejectionNCT03430414Thomas Mueller50
已完成
Unknown
Treatment of renal transplant recipients with low bone mineral density and vascular calcification: a prospective study of alendronate therapy.Kidney transplant recipients for secondary osteoporosis and vascular calcificationJPRN-jRCT1091220155Masanori Okamoto20
招募中
不适用
Clinical study using data of kidney transplant patientsKidney transplantationJPRN-UMIN000027833Keio University School of Medicine100