Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® PDT
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Percent Change From Baseline in Lesion Count at Week 18
研究概览
简要总结
The aim of this study is to determine possible molecular changes on large scale gene expression profiling after treatment with Metvix photodynamic therapy (PDT) of actinic keratoses (AK) and cancerised field in renal transplant recipients.
详细描述
In this study, the whole target area defined by the investigator will be treated by Metvix PDT: this means that both lesions and sub-clinical lesions will be exposed to Metvix PDT. Biopsies will be performed in both regions: lesional and peri-lesional ones. This will allow us to compare pre and post treatment molecular changes that occurred in these regions and so to evaluate if Metvix PDT acts on the sub-clinical lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal transplant with an history of immunosuppression from 5 to 15 years,
- •Presenting at least 4 discrete AK lesions, mild or moderate, either on the face, the scalp, forearms or the chest.
排除标准
- •At risk in terms of precautions, warnings, and contra-indication referred in the package insert of Metvix®,
- •AK lesions clinically atypical or suspicious for malignancy on the target field,
- •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.
- •Systemic retinoids within the last month prior to Screening visit.
结局指标
主要结局
Percent Change From Baseline in Lesion Count at Week 18
时间窗: Baseline and Week 18.
Percent Change in Lesion Counts at Week 18: Week 18 count minus Baseline count divided by Baseline count multiplied by 100.
次要结局
- Global Percent Change From Baseline in AK Lesion Count in the Target Field (Including New and Recurrent Lesions) at Month15(Baseline and Month15)