A Multicenter, Phase III, Double Blind Study of Photodynamic Therapy (PDT) With Metvix 160 mg/g Cream in Comparison to PDT With Placebo Cream in Patients 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
- 65
- 试验地点
- 9
- 主要终点
- Number of Participants With Histologically Confirmed Complete Response
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 have 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 photoactive porphyrins levels 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 participants complete response rates based on histologically verified disappearance of the lesions at 6 months after last treatment cycle. Secondary objectives was 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 participants were randomised to PDT with Metvix cream or PDT with placebo cream. All eligible basal cell carcinoma (BCC) lesions within a participant received same treatment. All participants received two consecutive treatments one week apart. At the 3-months follow-up visit, lesions with no clinical response or progression were surgically excised. Lesions with partial response 50 percent (%) or greater reduction on lesion area) were re-treated; if they do not show complete response three months later, they were surgically excised. Lesions with complete response were surgically excised 6 months after the first or second PDT cycle. All excised tissue specimens were 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.
- •Participants with Gorlin's syndrome.
- •Participants with Xeroderma pigmentosum.
- •Participants concurrently receiving immunosuppressive medication.
- •Participants with a history of arsenic exposure.
- •Participants with BCC arising in a previous radiated area.
- •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 millimeter (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
Photodynamic Therapy (PDT) WIth Metvix Cream 160 milligrams/gram (mg/g)
Participants with BCC lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
干预措施: Photodynamic Therapy (PDT) (Radiation)
Photodynamic Therapy (PDT) WIth Metvix Cream 160 milligrams/gram (mg/g)
Participants with BCC lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
干预措施: Metvix cream (Drug)
Placebo Cream
Participants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 J/cm*2 and fluency rate of 50-200 mW/cm*2 up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
干预措施: Photodynamic Therapy (PDT) (Radiation)
Placebo Cream
Participants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 J/cm*2 and fluency rate of 50-200 mW/cm*2 up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
干预措施: Placebo Cream (Drug)
结局指标
主要结局
Number of Participants With Histologically Confirmed Complete Response
时间窗: up to 9 months
The histological complete response was defined as 100 percent (%) of the lesions within the participant having negative findings 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 disappearence of lesion. Number of participants with histologically confirmed complete response were reported.
次要结局
- Percentage of Lesions With Histologically Confirmed Complete Lesion Response(up to 9 months)
- Percentage of Lesions With Clinically Confirmed Complete Lesion Response(up to 9 months)
- Histological Verified Lesions With Complete Response(up to 9 months)
- Clinically Verified Lesions With Complete Response(up to 9 months)
- Number of Participants With Clinically Evaluated Complete Response(up to 9 months)
- Number of Participants With Cosmetic Outcome Assessed by Investigator and Participants(up to 9 months)
- Number of Participants With Adverse Events and Serious Adverse Events (AEs)(up to 6 months)