| Primary | Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT or Cryotherapy 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 or Cryotherapy cycle, up to 6 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Cryotherapy | Cryotherapy was performed with a hand-held liquid nitrogen spray, using a double freeze-thaw cycle. After an initial icefield formation with a 3 millimeter (mm) rim of clinically healthy tissue, the icefield was to be maintained for a minimum of 20 seconds. This procedure was repeated after a thaw of 2-3 times the freeze time up to 12 weeks. |
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| Secondary | Number of Lesion With Complete Response 3 Months After Last Metvix PDT or Cryotherapy 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 | | lesion | | 3 months after last Metvix PDT or Cryotherapy cycle, up to 6 months | lesion | lesion | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Cryotherapy | Cryotherapy was performed with a hand-held liquid nitrogen spray, using a double freeze-thaw cycle. After an initial icefield formation with a 3 millimeter (mm) rim of clinically healthy tissue, the icefield was to be maintained for a minimum of 20 seconds. This procedure was repeated after a thaw of 2-3 times the freeze time up to 12 weeks. |
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| Secondary | Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT or Cryotherapy 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. | Posted | | Count of Participants | | Participants | | 3 months after the last metvix PDT or Cryotherapy cycle (Up to 6 months) | | | | ID | Title | Description |
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| OG000 | 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. | |
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| Secondary | Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT or Cryotherapy 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 or Cryotherapy cycle (Up to 6 months) | | | | ID | Title | Description |
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| OG000 | 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. | |
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| Secondary | Recurrence Rate in Complete Clearance Group | Recurrence rate in complete clearance 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. | Posted | | Number | | lesion | | 12, 24, 36, 48 and 60 months after last Metvix PDT cycle or Cryotherapy (Up to 5 years) | lesion | lesion | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Cryotherapy | Cryotherapy was performed with a hand-held liquid nitrogen spray, using a double freeze-thaw cycle. After an initial icefield formation with a 3 millimeter (mm) rim of clinically healthy tissue, the icefield was to be maintained for a minimum of 20 seconds. This procedure was repeated after a thaw of 2-3 times the freeze time up to 12 weeks. |
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| Secondary | Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT or Cryotherapy 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, 48, and 60 Months After the Last Metvix PDT Cycle (Up to 5 years) | | | | ID | Title | Description |
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| OG000 | 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. |
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