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Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulate more photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon illumination.
For skin diseases, there has been an increasing interest in using precursors of the endogenous photoactive porphyrins. The most commonly used precursors have been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix®, contains the methyl ester of ALA, which penetrates the lesions well and shows high lesion selectivity .
BCC is a highly frequent skin malignancy, and accounts for approximately 75% of all non-melanoma skin cancers. It is the most common cancer in humans. Several non-pharmacological treatment modalities are used for BCC, including excision surgery, curettage and electrodesiccation, cryosurgery and more advanced modalities like radiation therapy, plastic surgery with reconstruction and Moh's surgery. The treatment used depends on the type, size, depth and localisation of the BCC lesion. Treatment options for BCC give good response rates in the majority of participants but are inadequate in a small group of participants defined as "high-risk" BCC.
In this particular participant group, even a moderate complete response rate with good cosmetic results may be considered beneficial, since the number of participant who have to receive more advanced therapy with the possibility of high morbidity and poor cosmetic outcome was reduced. Even a partial response is of clinical interest since the remaining tumour was require less extensive surgery. In the case of treatment failure, Metvix PDT does not interfere with the use of other treatment modalities.
The variable "complete response" after one or two Metvix treatment cycles was used as the basis for the justification of sample size.
Prospective, open, multicenter study. The high risk BCC lesions were treated with Metvix cream. A biopsy confirming the diagnosis of each BCC lesion should have been taken within 6 months prior to treatment. The participants was receive one or two treatment cycles each consisting of two Metvix PDT treatments 7 days apart (Lesions that did not respond completely after three months received a second PDT treatment cycle).
The primary end-point was the histologically confirmed complete response rate within a participant (No BCC cells in the biopsy taken 3 months after the last treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metvix® PDT | Experimental | Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm*2) up to 13 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metvix® cream | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT Cycle | Patient 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. | 3 months after last Metvix PDT cycle, up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Lesion With Complete Response 3 Months After Last Metvix PDT Cycle | Complete response was defined as no clinically visible BCC lesions in the treatment area. | 3 months after last Metvix PDT cycle, up to 6 months |
| Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT Cycle |
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Inclusion Criteria:
Participants with high risk of surgical complications due to:
OR
• Participants with "high-risk BCC lesion(s). A "high-risk" BCC lesion is defined as:
A large BCC lesion with the largest diameter:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl Vinciullo, MD | Dermatology Surgery & Laser Centre, Perth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, St. George Hospital | Kogarah | New South Wales | NSW 2217 | Australia | ||
| South East Dermatology, The Belmont Specialist Clinic |
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A total of 102 participants were randomized at seven different center in Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Metvix® PDT | Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm*2) up to 13 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Metvix® PDT | Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm*2) up to 13 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT Cycle | Patient 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. | Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. | Posted | Number | percentage of participants | 3 months after last Metvix PDT cycle, up to 6 months |
|
Baseline up to Month 60
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metvix® PDT | Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm*2) up to 13 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.com |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as:
|
| 3 months after the last metvix PDT cycle, up to 6 months |
| Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT Cycle | Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The participants graded the cosmetic outcome as: excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin fair: slight to moderate occurrence of scarring, atrophy or induration poor: extensive occurrence of scarring, atrophy or induration. | 3 months after the last metvix PDT cycle, up to 6 months |
| Recurrence Rate in Complete Clearance Group | Recurrence rate in complete clearance(CC) group was analyzed. | 12, 24, 36, 48 and 60 months after last Metvix PDT cycle, up to 5 years |
| Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle | Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as: excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin fair: slight to moderate occurrence of scarring, atrophy or induration poor: extensive occurrence of scarring, atrophy or induration. | 24, 36, and 60 Months After the Last Metvix PDT Cycle, up to 5 years |
| Carnia |
| Queensland |
| 4152 |
| Australia |
| Department of Dermatology, Royal Adelaide Hospital | Adelaide | South Australia | SA 5000 | Australia |
| Dermatology Department, The Queen Elisabeth Hospital | Adelaide | South Australia | SA 5011 | Australia |
| Clinic B, Repatriation Campus, Austin & Repatriation Medical Centre | Heidelberg | Victoria | VIC 3081 | Australia |
| Fremantle Dermatology | Fremantle | Western Australia | WA 6106 | Australia |
| Dermatology Surgery & Laser Centre, The Perth Surgicentre | Perth | Western Australia | WA 6151 | Australia |
| Withdrew consent |
|
| Other un-specified reason |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Number of Lesion With Complete Response 3 Months After Last Metvix PDT Cycle | Complete response was defined as no clinically visible BCC lesions in the treatment area. | Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. | Posted | Number | lesions | 3 months after last Metvix PDT cycle, up to 6 months | lesions | lesions |
|
|
|
| Secondary | Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT Cycle | Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as:
| Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. Here overall "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | 3 months after the last metvix PDT cycle, up to 6 months |
|
|
|
| Secondary | Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT Cycle | Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The participants graded the cosmetic outcome as: excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin fair: slight to moderate occurrence of scarring, atrophy or induration poor: extensive occurrence of scarring, atrophy or induration. | Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. Here overall "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | 3 months after the last metvix PDT cycle, up to 6 months |
|
|
|
| Secondary | Recurrence Rate in Complete Clearance Group | Recurrence rate in complete clearance(CC) group was analyzed. | Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. Here overall "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. "Number analyzed", signifies those participants who were evaluable for this outcome measure at the specified time point. | Posted | Count of Participants | Participants | 12, 24, 36, 48 and 60 months after last Metvix PDT cycle, up to 5 years |
|
|
|
| Secondary | Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle | Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as: excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin fair: slight to moderate occurrence of scarring, atrophy or induration poor: extensive occurrence of scarring, atrophy or induration. | Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. Here overall "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. "Number analyzed", signifies those participants who were evaluable for this outcome measure at the specified time point. | Posted | Count of Participants | Participants | 24, 36, and 60 Months After the Last Metvix PDT Cycle, up to 5 years |
|
|
|
| 7 |
| 102 |
| 10 |
| 102 |
| 88 |
| 102 |
| Burning sensation skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Surgical intervention | General disorders | Non-systematic Assessment |
|
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Stroke | Vascular disorders | Systematic Assessment |
|
| Peripheral vascular disease | Vascular disorders | Non-systematic Assessment |
|
| Systemic infection | Infections and infestations | Non-systematic Assessment |
|
| Encephalopathy | Hepatobiliary disorders | Non-systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Influenza like symptom | General disorders | Non-systematic Assessment |
|
| Back ache | General disorders | Non-systematic Assessment |
|
| Leg pain | General disorders | Non-systematic Assessment |
|
| Allergic reaction | Cardiac disorders | Non-systematic Assessment |
|
| Cervical pain | General disorders | Non-systematic Assessment |
|
| Heaviness in limbs | General disorders | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | Non-systematic Assessment |
|
| Feeling cold | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Sensation of warmth | General disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Stomach upset | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Basel cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Skin neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Skin carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Infection fungal | Infections and infestations | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | Non-systematic Assessment |
|
| Herpes simplex | Immune system disorders | Non-systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain neck shoulder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Mental distress | Psychiatric disorders | Non-systematic Assessment |
|
| psychosis | Psychiatric disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Eye pain | Eye disorders | Non-systematic Assessment |
|
| conjunctivitis | Eye disorders | Non-systematic Assessment |
|
| Stroke | Vascular disorders | Non-systematic Assessment |
|
| Skin warm | Vascular disorders | Non-systematic Assessment |
|
| Peripheral vascular disease | Vascular disorders | Non-systematic Assessment |
|
| Haematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Epistaxis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Coughing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | Non-systematic Assessment |
|
| Application site reaction | General disorders | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Surgical intervention | Surgical and medical procedures | Non-systematic Assessment |
|
| Abrasion NOS | Surgical and medical procedures | Non-systematic Assessment |
|
| Prostatic specific antigen INCR. | Surgical and medical procedures | Non-systematic Assessment |
|
| Heart Failure | Cardiac disorders | Non-systematic Assessment |
|
| Liver failure related to Chronic Hepatitis B infection | Hepatobiliary disorders | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
|
| Cerebrovascular accident | Vascular disorders | Non-systematic Assessment |
|
| Metastatic squamous cell carcinoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D018295 |
| Neoplasms, Basal Cell |
| Title | Measurements |
|---|---|
|
| Investigator: Not applicable |
|
| Title | Measurements |
|---|---|
|
| Participants: Not applicable |
|
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| 36 months |
|
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| 48 months |
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| 60 months |
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| Fair: At 24 month |
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| Poor: At 24 month |
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| Excellent: At 36 month |
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| Good: At 36 month |
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| Fair: At 36 month |
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| Excellent: At 60 month |
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| Good: At 60 month |
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| Fair: At 60 month |
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