| Primary | Number of Accumulated New Skin Lesions 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. | Intent-to-Treat (ITT) Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm. | Posted | | Number | | new skin lesions | | At Month 3 | skin lesions | skin lesions | | ID | Title | Description |
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| OG000 | Metvix®- PDT (Treatment Area) | Two contralateral areas (symmetrically) were identified with an area of 5*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27. | | OG001 | Contralateral Control Area | The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27. |
| | Units | Counts |
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| Participants | | | skin lesions | |
| | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | t-test, 2 sided | | 0.0120 | | Mean Difference (Final Values) | 0.514 | | | 2-Sided | 95 | 0.116 | 0.911 | | | The 95 % confidence intervals for the lesion complete response rates and lesion recurrence rates were estimated using the method of Clopper and Pearson. | | Non-Inferiority | Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type. | |
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| Primary | Number of Accumulated New Skin Lesions 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. | ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm. | Posted | | Number | | new skin lesions | | At Month 9 | skin lesions | skin lesions | | ID | Title | Description |
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| OG000 | Metvix®-PDT (Treatment Area) | Two contralateral areas (symmetrically) were identified with an area of 5*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3 ,9, 15, 21 and 27. | | OG001 | Contralateral Control Area | The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27. |
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| Primary | Number of Accumulated New Skin Lesions 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. | ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm. | Posted | | Number | | new skin lesions | | At Month 15 | skin lesions | skin lesions | | ID | Title | Description |
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| OG000 | Metvix®-PDT (Treatment Area) | Two contralateral areas (symmetrically) were identified with an area of 5*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27. | | OG001 | Contralateral Control Area | The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (e.g., cryotherapy) at months 3, 9, 15, 21 and 27. |
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| Primary | Number of Accumulated New Skin Lesions 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. | ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm. | Posted | | Number | | new skin lesions | | At Month 21 | skin lesions | skin lesions | | ID | Title | Description |
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| OG000 | Metvix®-PDT (Treatment Area) | Two contralateral areas (symmetrically) were identified with an area of 5*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27. | | OG001 | Contralateral Control Area | The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (e.g., cryotherapy) at months 3, 9, 15, 21 and 27. |
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| Primary | Number of Accumulated New Skin Lesions 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. | ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm. | Posted | | Number | | new skin lesions | | At Month 27 | skin lesions | skin lesions | | ID | Title | Description |
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| OG000 | Metvix®- PDT (Treatment Area) | Two contralateral areas (symmetrically) were identified with an area of 5*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27. | | OG001 | Contralateral Control Area | The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (e.g., cryotherapy) at months 3, 9, 15, 21 and 27. |
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| Primary | Number of AK Lesions That Showed Complete Response 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. | ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm. | Posted | | Number | | skin lesions | | At Month 3 | skin lesions | skin lesions | | ID | Title | Description |
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| OG000 | Metvix®-PDT (Treatment Area) | Two contralateral areas (symmetrically) were identified with an area of 5*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27. | | OG001 | Contralateral Control Area | The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27. |
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| Primary | Number of AK Lesions That Showed Complete Response 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. | ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm. | Posted | | Number | | skin lesions | | At Month 9 | skin lesions | skin lesions | | ID | Title | Description |
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| OG000 | Metvix®-PDT (Treatment Area) | Two contralateral areas (symmetrically) were identified with an area of 5*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27. | | OG001 | Contralateral Control Area | The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27. |
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| Primary | Number of AK Lesions That Showed Complete Response 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. | ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm. | Posted | | Number | | skin lesions | | At Month 15 | skin lesions | skin lesions | | ID | Title | Description |
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| OG000 | Metvix®-PDT (Treatment Area) | Two contralateral areas (symmetrically) were identified with an area of 5*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27. | | OG001 | Contralateral Control Area | The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27. |
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| Primary | Number of AK Lesions That Showed Complete Response 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. | ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm. | Posted | | Number | | skin lesions | | At Month 21 | skin lesions | skin lesions | | ID | Title | Description |
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| OG000 | Metvix®-PDT (Treatment Area) | Two contralateral areas (symmetrically) were identified with an area of 5*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27. | | OG001 | Contralateral Control Area | The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27. |
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| Primary | Number of AK Lesions That Showed Complete Response 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. | ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm. | Posted | | Number | | skin lesions | | At Month 27 | skin lesions | skin lesions | | ID | Title | Description |
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| OG000 | Metvix®-PDT (Treatment Area) | Two contralateral areas (symmetrically) were identified with an area of 5*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27. | | OG001 | Contralateral Control Area | The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27. |
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| Secondary | Number of BCC Lesions That Showed Complete Response | Complete response was defined as the complete disappearance of the lesion. BCC lesions were characterized as superficial: ill-defined red scaly macule; could increase in size to form crusted, occasionally ulcerated, scaly erythematous patches, but never indurated and nodular: flesh-colored, cream to pink, waxy papule with prominent surface telangiectasias; as the lesions grow, central erosion or ulceration and crusting occur, surrounded by a pearly, rolled, translucent border. Number of BCC lesions that showed complete response was reported. | ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of BCC lesions analyzed in each Arm. | Posted | | Number | | skin lesions | | At Months 3, 9, 15, 21 and 27 | skin lesions | skin lesions | | ID | Title | Description |
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| OG000 | Metvix®-PDT (Treatment Area) | Two contralateral areas (symmetrically) were identified with an area of 5*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27. | | OG001 | Contralateral Control Area | The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27. |
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| Secondary | Number of Recurrent Lesions | Recurrence of lesions was defined as reappearance of previously treated and eradicated lesions and was verified by histology in accordance with local hospital practice. | ITT population included all participants who were enrolled and treated at baseline. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm. | Posted | | Number | | skin lesions | | At Months 9, 15, 21 and 27 | skin lesions | skin lesions | | ID | Title | Description |
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| OG000 | Metvix®-PDT | Two contralateral areas (symmetrically) were identified with an area of 5*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27. | | OG001 | Placebo-PDT | The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27. |
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| Secondary | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Overall cosmetic outcome for the two contralateral areas (treatment and contralateral control) with an area of 5 by 10 cm^2 was assessed with regards to either absence or presence of all signs or symptoms or the presence of at least one of the signs or symptoms; scarring, atrophy, depigmentation, redness and fibrosis by both investigator and participant. Parameters were assessed for each area were hypopigmentation, hyperpigmentation, scar formation and tissue defect. The occurrence of these parameters was graded as none, slight, or obvious. Cosmetic outcome was presented as number of participants in each category (none, slight, obvious) for each variable assessed (hypopigmentation, hyperpigmentation, scar formation, tissue defect). | ITT-population. Here, "overall number of participants analyzed" signifies number of participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for each specified category. | Posted | | Count of Participants | | Participants | | At Month 27 | | | | ID | Title | Description |
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| OG000 | Metvix®-PDT (Treatment Area) | Two contralateral areas (symmetrically) were identified with an area of 5*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27. | | OG001 | Contralateral Control Area |
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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety Population that included in the study and received Metvix® cream were included in safety evaluation. | Posted | | Count of Participants | | Participants | | From Baseline up to Month 27 | | | | ID | Title | Description |
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| OG000 | Metvix®-PDT | Two contralateral areas (symmetrically)were identified with an area of 5*10-centimeter square,i.e., treatment and control area. Treatment area was treated with Metvix® PDT 160mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments given were given at Months 3, 9, 15, 21 and 27. Adverse Events localized to the treatment area are reported. | | OG001 | Contralateral Control Area | The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21and 27. Adverse Events localized to the contralateral Control Area. |
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