| Primary | Number of Participants With Histologically Confirmed Complete Response | 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. | Intent-to-treat (ITT) population included all participants who had BCC lesions and had received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | up to 9 months | | | | ID | Title | Description |
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| OG000 | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | Participants with basal cell carcinoma (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. | | OG001 | Photodynamic Therapy (PDT) With 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 Joule per centimeter square (J/cm*2) and fluency rate of 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. |
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| Secondary | Percentage of Lesions With Histologically Confirmed Complete Lesion Response | Histological response weight means no signs of malignant basal cells in all microscopical slides containing excised tissue. The histologically confirmed complete lesion response were reported. | ITT population included all participants who had BCC lesions and had received at least one dose of study drug. | Posted | | Number | | percentage of lesions | | up to 9 months | Lesions | Lesions | | ID | Title | Description |
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| OG000 | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | Participants with basal cell carcinoma (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. | | OG001 | Photodynamic Therapy (PDT) With 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 Joule per centimeter square (J/cm*2) and fluency rate of 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. |
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| Secondary | Percentage of Lesions With Clinically Confirmed Complete Lesion Response | Clinically confirmed complete lesion response means no signs of malignant basal cells in all microscopical slides containing excised tissue. The clinically confirmed complete lesion response were reported. | ITT population included all participants who had BCC lesions and had received at least one dose of study drug. | Posted | | Number | | percentage of Lesions | | up to 9 months | Lesions | Lesions | | ID | Title | Description |
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| OG000 | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | Participants with basal cell carcinoma (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. | | OG001 | Photodynamic Therapy (PDT) With 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 Joule per centimeter square (J/cm*2) and fluency rate of 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. |
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| Secondary | Histological Verified Lesions With Complete Response | Histological confirmed complete lesion response means no signs of malignant basal cells in all microscopical slides containing excised tissue. Number of histologically confirmed lesions with complete response were reported. | ITT population set included all participants who had BCC lesions and received at least one dose of study drug. | Posted | | Number | | Lesions | | up to 9 months | Lesions | Lesions | | ID | Title | Description |
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| OG000 | Photodynamic Therapy (PDT) Metvix Cream 160 Milligram/Gram (mg/g) | Photodynamic Therapy (PDT) With Metvix Cream 160 (milligram/gram): 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 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. | | OG001 | Photodynamic Therapy (PDT) Placebo Cream | Photodynamic Therapy (PDT) With Placebo Cream: Participants with basal cell carcinoma (BCC) lesions were administered to PDT with Placebo cream applied 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 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. |
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| Secondary | Clinically Verified Lesions With Complete Response | Clinically confirmed complete lesion response means no signs of malignant basal cells in all microscopical slides containing excised tissue. Number of clinically confirmed lesions with complete response were reported. | ITT population set included all participants who had BCC lesions and received at least one dose of study drug. | Posted | | Number | | Lesions | | up to 9 months | Lesions | Lesions | | ID | Title | Description |
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| OG000 | Photodynamic Therapy (PDT) Metvix Cream 160 Milligram/Gram (mg/g) | Photodynamic Therapy (PDT) With Metvix Cream 160 (milligram/gram): Participants with BCC lesions were administered to PDT with Metvix® cream 160 mg/g applied for three hours, followed by illumination using noncoherent light with a fluency of 75 J/cm*2 and fluency rate of less than 50-200 mW/cm*2 up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle. | | OG001 | Photodynamic Therapy (PDT) Placebo Cream | Photodynamic Therapy (PDT) With Placebo Cream: Participants with BCC lesions were administered to PDT with Placebo cream applied 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. |
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| Secondary | Number of Participants With Clinically Evaluated Complete Response | The on-site investigator evaluated the lesion response by comparing to the lesion size before and after treatment. Complete response here means complete disappearance of a lesion. Number of participants for whom one or more lesions had a complete response were reported. | ITT population set included all participants who had BCC lesions and received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | up to 9 months | | | | ID | Title | Description |
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| OG000 | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | Participants with basal cell carcinoma (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. | | OG001 | Photodynamic Therapy (PDT) With 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 Joule per centimeter square (J/cm*2) and fluency rate of 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. |
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| Secondary | Number of Participants With Cosmetic Outcome Assessed by Investigator and Participants | Cosmetic outcomes were assessed with regards to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. Cosmetic outcome were graded as excellent, good, fair or poor where: excellent: no scarring, atrophy or induration, no or slight occurrence of redness or change in pigmentation compared to 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 and Poor: extensive occurrence of scarring, atrophy or induration. The investigator and participants assessed the cosmetic outcome for each lesion has responded completely. Participants were asked to evaluate evaluate the cosmetic outcome according to the same categories: excellent, good, fair cosmetic outcome. Number of participants with summarized cosmetic outcomes for all symptoms as assessed by Investigator and participants were reported. | ITT population set included all participants who had BCC lesions and received at least one dose of study drug. Here, "Overall Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Number analyzed = participantswith available data for specified category. | Posted | | Count of Participants | | Participants | | up to 9 months | | | | ID | Title | Description |
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| OG000 | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligram/Gram (mg/g) | Participants with basal cell carcinoma (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. |
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| Secondary | Number of Participants With Adverse Events and Serious Adverse Events (AEs) | Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs: events between first dose of study drug that were absent before treatment/that worsened relative to pre-treatment state. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with AEs and serious AEs were reported. | The Safety population included all participants in the ITT who were administered at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | up to 6 months | | | | ID | Title | Description |
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| OG000 | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | Participants with basal cell carcinoma (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. | | OG001 | Photodynamic Therapy (PDT) WIth Placebo Cream |
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