A Multicentre, Phase III, Double Blind Study of Photodynamic Therapy (PDT) With Metvix® 160 mg/g Cream in Comparison to PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 66
- 试验地点
- 7
- 主要终点
- Percentage of Participants With Histologically Confirmed Complete Response (CR)
研究概览
简要总结
Photodynamic therapy (PDT) was the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulated more photosensitiser than normal cells. The photosensitiser generated reactive oxygen species upon illumination.
For skin diseases, there had been an increasing interest in using precursors of the endogenous photosensitiser protoporphyrin IX (PpIX). The most commonly used precursors had been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix®, contained the methyl ester of ALA, which penetrated the lesions well and shows high lesion selectivity .
In vitro studies of animal and human tissues had shown significant intracellular formation of photoactive porphyrins after addition of Metvix®. The increased levels of photoactive porphyrins induced cytotoxic effects in tumour cells after photoactivation.
The primary objective was to compare PDT with Metvix® cream to PDT with placebo cream in terms of participant complete response rates based on histologically verified disappearance of the lesions at 6 months after last treatment cycle.
Secondary objectives were to compare the two treatments in terms of histological and clinical mean participant response weighted by the number of lesions within a participant, lesion response rates across participants, clinical complete participant response, cosmetic outcome and adverse events.
详细描述
A participant was randomised to PDT with Metvix® cream or PDT with placebo cream. All eligible Basal cell carcinoma (BCC) lesions within a participant had got the same treatment. All participants got two consecutive treatments one week apart. At the 3-months follow-up visit, lesions with no clinical response or progression had been surgically excised. Lesions with partial response (50% or greater reduction on lesion area) had been re-treated, if they do not show complete response three months later they would have been be surgically excised. Lesions with complete response had been surgically excised 6 months after the first or second PDT cycle. All excised tissue specimens had been histologically examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •A participant with primary, nodular BCC lesion(s) suitable for entry is defined as a participant with
- •Clinically diagnosed primary nodular BCC lesion(s).
- •Histologically confirmed diagnosis of BCC.
- •BCC lesions suitable for simple excision surgery.
- •Males or females above 18 years of age.
- •Written informed consent.
排除标准
- •A participant that is ineligible for inclusion is a participant fulfilling any of the following criteria:
- •Participants with porphyria.
- •Participant with Gorlin's syndrome.
- •Participant with Xeroderma pigmentosum.
- •Participants concurrently receiving immunosuppressive medication.
- •Participants with a history of arsenic exposure.
- •Known allergy to Metvix®, a similar PDT 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 must use adequate contraception (e.g. barrier methods, oral contraceptives or intrauterine device) during the treatment period and one month thereafter. In addition, they must have a negative pregnancy test prior to treatment.
- •Conditions associated with a risk of poor protocol compliance.
- •Lesion Exclusion Criteria:
- •A nodular BCC lesion in periorbital area, ears and nasolabial fold.
- •A nodular BCC lesion with the longest diameter less than 6 mm or larger than 15 mm in face/scalp, larger than 20 mm on extremities and neck and larger than 30 mm on truncus.
- •Pigmented nodular BCC lesion(s).
- •Morpheaform nodular BCC lesion(s).
- •Infiltrating nodular BCC lesion(s).
- •Prior treatment of the BCC lesion(s).
研究组 & 干预措施
Metvix® cream 160 milligram per gram
Methyl aminolevulinate hydrochloride 160 milligram (mg)/gram (g) cream were received by participants with primary nodular basal cell carcinoma. A thick layer of study cream was applied directly on the lesion and on 5 mm of the surrounding tissue. An approximately 1 mm thick layer of cream was applied to cover the lesion completely. The study cream was applied for at least 3 hours followed by illumination using non-coherent red (570-670 nm) light at a fluence of 50- 75 J/cm^2.
干预措施: PDT with Metvix 160 mg/g cream (Drug)
Placebo
Participants with primary nodular basal cell carcinoma received Metvix® matching placebo cream. A thick layer of study cream was applied directly on the lesion and on 5 mm of the surrounding tissue. An approximately 1 mm thick layer of cream was applied to cover the lesion completely. The study cream was applied for at least 3 hours followed by illumination using non-coherent red (570-670 nm) light at a fluence of 50- 75 J/cm^2.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Histologically Confirmed Complete Response (CR)
时间窗: up to 6 months
Complete Response (CR) was defined as 100 percentage of the lesions within the participant having negative findings for nodular basal cell carcinoma (BCC) in the histological examination. Histological examination included evaluation of all the microscopical slides from the excised tissue for presence of malignant basal cells. Complete response was defined as complete disappearance of lesion. Percentage of participants with histologically confirmed complete response were reported.
次要结局
- Histological Lesion Response(Up to 3 months)
- Percentage of Lesions Per Participant: Histologically Confirmed Participant Weighted Response(Up to 3 months)
- Cosmetic Outcomes for Lesions Assessed by Investigator(Up to 3 months)
- Percentage of Participants With Clinically Confirmed Participant Complete Response (CR)(Up to 9 months)
- Cosmetic Outcomes for Lesions Assessed by Participants(Up to 3 months)
- Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Discontinuation(Up to 6 months)