A Multicenter, Randomized Study of Photodynamic Therapy (PDT) With Metvix® 160 mg/g Cream in Immuno-compromised Patients With Non-melanoma Skin Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 82
- 试验地点
- 22
- 主要终点
- Number of Accumulated New Skin Lesions at Month 3
研究概览
简要总结
Participants on immunosuppressive therapy, e.g., organ recipients, had higher occurrence of AK (Actinic Keratosis) than the untreated population. Keratotic lesions (i.e., AK lesions and warts) in this population were highly associated with development of SCC (Squamous Cell Carcinoma) also with 10 times higher mortality rate because of SCC than expected. The risk of developing skin cancer, predominantly SCC and BCC (Basal Cell Carcinoma), increased with graft survival time and the length of immunosuppressive treatment period.
The higher risk of developing skin malignancy and more aggressive skin malignancies in this population, indicated the need for early removal of these pre-malignant lesions.
In this study, two contralateral areas (5x10 cm^2) with skin lesions within the participant were compared. One area was received Metvix PDT at defined intervals and the other was received lesion specific treatment at the discretion of the investigator. The primary endpoint was the accumulated number of new lesions during the study and number of AK lesions that showed complete response 3 months after baseline. Secondary endpoints were number of BCC lesions that showed complete response, number of recurrent lesions, assessment of cosmetic outcome and safety.
详细描述
The treatment area (5x10 cm^2) was treated at baseline and at 3 ,9 and 15 months visits. At baseline, the area was treated with fractionated Metvix® PDT treatment consisting of two treatment one week apart and at 3 ,9 and 15 months visits with single Metvix® PDT treatment. The participants were evaluated for occurrence of new lesions, lesion response and recurrence at 3 (not recurrence),9,15,21, and 27 months visits. New and recurrent lesions in the treated area were treated with Metvix® PDT treatment. Lesions with partial response in the treated area were re-treated with Metvix® PDT and lesions with no response were treated with lesion specific treatment at the discretion of the investigator.
In the contralateral control area (5x10 cm^2), new and recurrent lesions and lesions in non-complete response were treated with lesion specific treatment at the discretion of the investigator at each study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Transplant recipients with at least 2 clinically diagnosed AK lesion and maximum 10 skin lesions (AK, BCC, SCC in situ and/or warts) in each of the two contralateral areas (diameter 5x10^2 cm) in the face, the scalp, the extremities or on the trunk/neck.
- •Transplant recipients who previously were treated more than once for their skin lesions.
- •Transplant recipients who had received immunosuppressive therapy for more than 3 years.
- •Males or females above 18 years of age.
- •Written informed consent.
排除标准
- •Participants with more than 10 skin lesions (AK, BCC, SCC in situ, warts) in one of the two areas.
- •Participants with SCC (not SCC in situ) in one of the two areas.
- •Participants not previously treated or treated only once for their skin lesions.
- •Participants with rosacea in one of the two areas.
- •Participants with morphea form/highly infiltrating BCC
- •Known allergy to methyl-amino levulinate, a similar compound or excipients of the cream
- •Participation in other clinical studies either concurrently or within the last 30 days.
- •Pregnant or breast-feeding (all women of child-bearing potential documented a negative pregnancy test and used the pill or IUD during the treatments and for at least one month thereafter).
- •Conditions associated with a risk of poor protocol compliance
结局指标
主要结局
Number of Accumulated New Skin Lesions at Month 3
时间窗: At Month 3
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of actinic keratoses (AK) lesions, basal cell carcinoma (BCC) lesions, squamous cell carcinoma (SCC) lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 3 were reported.
Number of Accumulated New Skin Lesions at Month 9
时间窗: At Month 9
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 9 were reported.
Number of Accumulated New Skin Lesions at Month 15
时间窗: At Month 15
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 15 were reported.
Number of Accumulated New Skin Lesions at Month 21
时间窗: At Month 21
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 21 were reported.
Number of Accumulated New Skin Lesions at Month 27
时间窗: At Month 27
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 27 were reported.
Number of AK Lesions That Showed Complete Response at Month 3
时间窗: At Month 3
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Number of AK Lesions That Showed Complete Response at Month 9
时间窗: At Month 9
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Number of AK Lesions That Showed Complete Response at Month 15
时间窗: At Month 15
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Number of AK Lesions That Showed Complete Response at Month 21
时间窗: At Month 21
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Number of AK Lesions That Showed Complete Response at Month 27
时间窗: At Month 27
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
次要结局
- Number of BCC Lesions That Showed Complete Response(At Months 3, 9, 15, 21 and 27)
- Number of Recurrent Lesions(At Months 9, 15, 21 and 27)
- Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants(At Month 27)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Baseline up to Month 27)