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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-004237-15 | EudraCT Number |
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Skin photoaging or skin photodamage were terms used to describe the change in the structure, function and appearance of skin caused by prolonged and repeated exposure to sunlight or other ultraviolet light sources.
The visible effects of skin photodamage were fine lines, skin sagging, skin roughness, liver spots and also the appearance of red patches made up of thin red vessels (called telangiectasia).
More and more people were presenting to doctors with concerns about skin photodamage and the demand for corrective procedures was increasing.
Metvix photodynamic therapy (Metvix PDT) is a procedure currently marketed in several countries in Europe (including the United Kingdom [UK] and Spain) and in Australia, for the treatment of benign forms of skin cancer (example, actinic keratosis).
The aim of the study was to assess whether Metvix PDT would be effective in correcting the effects related to photodamage and whether it would be well tolerated.
Different application times of the study treatment were being investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metvix Cream 160 mg/g +Metvix Vehicle Cream (1 Hour Group) | Experimental | Participants were topically treated with 160 milligrams per gram (mg/g) Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light [using a large-field light emitting diode (LED) light source: Aktilite 128 lamp] during 7 to 10 minutes to deliver a total dose of 37 Joules per centimeter square J/cm^2. The total study duration was 20 weeks. |
|
| Metvix Cream 160 mg/g +Metvix Vehicle Cream (2 Hour Group) | Experimental | Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm^2. The total study duration was 20 weeks. |
|
| Metvix Cream 160 mg/g +Metvix Vehicle Cream (3 Hour Group) | Experimental | Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm^2. The total study duration was 20 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metvix Cream 160 mg/g | Drug | Participants were treated with topical administration of Metvix cream. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Severity of Photodamage | Severity of cutaneous photodamage in participants were assessed using Griffiths photo numeric scale. The severity scores of photodamage on the scale ranged from 0 (minimum) to 8 (maximum), that is, no damage (0), mild damage (1-3), moderate damage (4-6), and severe damage (7-8) where the highest score indicated worst outcome. | At Week 20 |
| Number of Participants With Severity of Mottled Hyper-Pigmentation | The evaluation of the severity of facial mottled hyperpigmentation were done using five-point scale. The score on the five-point scale ranged from 0 (minimum) to 4 (maximum), that is, 0 = none (no areas of mottled, irregular pigmentation), 1 = minimal (few, small lightly pigmented, discrete macules), 2 = mild (multiple, small lightly pigmented macules), 3 = moderate (widespread areas of mottled, moderately dark macules), 4 = severe (Widespread, multiple areas of dark macules/hyperpigmentation with uneven skin tone). The higher score indicated the worse outcome. | At Week 20 |
| Number of Participants With Severity of Fine Lines | The evaluation of the severity of facial fine lines were done using the five-point scale ranging from 0 to 4, that is, 0 = none- (lines disappear with stretching), 1 = minimal (few lines which do not completely disappear with stretching), 2 = mild (few lines which only diminish with stretching), 3 = moderate (widespread areas of lines which change minimally with stretching), 4 = severe- (widespread areas of lines which do not change at all with stretching), where the higher score indicated the worse outcome. | At Week 20 |
| Number of Participants With Severity of Telangiectasia | The severity of telangiectasia by using the scale ranging from 0 (minimum) to 3 (maximum), that is, 0 = absent (no telangiectasia), 1 = mild (slight telangiectasia characterized by appearance of a few fine, small red vessels [0.2 millimeters [mm] or less in diameter); telangiectasia covers less than 10 percent (%) of the target area, 2 = moderate (pronounced telangiectasia characterized by appearance of several fine vessels and/or few large vessels [0.2 mm or greater in diameter]; telangiectasia covers between 10 to 30% of the target area), 3 = severe (severe telangiectasia characterized by the appearance of many fine vessels and/or large vessels; telangiectasia covers greater than 30% of the target area), where the higher score indicated the worse outcome.](streamdown:incomplete-link) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CEM Griffiths | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Ruber | Madrid | Spain | ||||
| Whittington Hospital |
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| Label | URL |
|---|---|
| Related Info | View source |
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The study protocol was submitted to and approved by the local Ethics Committees prior to study initiation, and by the regulatory authorities. The study was followed-up closely by the Sponsor or representatives according to the Declaration of Helsinki (1964) and its Tokyo 9(175), Venice (1983), Hong-Kong (1989), Somerset West (1996), and Edinburgh (2000) amendments, the ICH Good Clinical Practice (GCP) principles, Standard Operating Procedures (SOPs) and local regulatory requirements.
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A total of 32 participants were enrolled in the study and randomized in three different groups (1 hour group, 2 hour group, and 3 hour group).
The study was conducted at 3 centers in the United Kingdom and Spain from 18 April 2007 to 1 September 2008.
| ID | Title | Description |
|---|---|---|
| FG000 | Metvix Cream 160 mg/g+Metvix Vehicle Cream (1 Hour Group) | Participants were topically treated with 160 milligrams per gram (mg/g) Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light [using a large-field light emitting diode (LED) light source: Aktilite 128 lamp] during 7 to 10 minutes to deliver a total dose of 37 Joules per centimeter square J/cm^2. The total study duration was 20 weeks. |
| FG001 | Metvix Cream 160 mg/g+Metvix Vehicle Cream (2 Hour Group) | Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm^2. The total study duration was 20 weeks. |
| FG002 | Metvix Cream 160 mg/g+Metvix Vehicle Cream (3 Hour Group) | Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm^2. The total study duration was 20 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Intent-to-treat (ITT) population included all enrolled and randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Metvix Cream 160 mg/g+Metvix Vehicle Cream (1 Hour Group) | Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm^2. The total study duration was 20 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 | Number of Participants With Severity of Photodamage | Severity of cutaneous photodamage in participants were assessed using Griffiths photo numeric scale. The severity scores of photodamage on the scale ranged from 0 (minimum) to 8 (maximum), that is, no damage (0), mild damage (1-3), moderate damage (4-6), and severe damage (7-8) where the highest score indicated worst outcome. | ITT population included all enrolled and randomized participants. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group." | Posted | Count of Participants | Participants | At Week 20 |
|
From first dose of administration up to Week 20
Safety population included all enrolled and randomized participants. As per planned analysis safety data was analyzed and collected for Metvix Cream 160 mg/g+Metvix Vehicle Cream (1 Hour Group), Metvix Cream 160 mg/g+Metvix Vehicle Cream (2 Hour Group) and Metvix Cream 160 mg/g+Metvix Vehicle Cream (3 Hour Group).
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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 160 mg/g Cream+Metvix Vehicle Cream (1 Hour Group) | Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm^2. The total study duration was 20 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pain | Eye disorders | MedDRA 9.1 | 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 |
|---|---|
| C475457 | methyl 5-aminolevulinate |
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|
| Metvix Vehicle Group | Drug | Participants were treated with topical administration of Metvix Vehicle cream. |
|
| At Week 20 |
| Number of Participants With Severity of Skin Roughness | The evaluation of the severity of skin roughness were done by using the five-point scale ranging from 0 to 4,that is, 0 = none ( very smooth, no patches of roughness), 1 = minimal (smooth with only a few patches of roughness), 2 = mild (mostly smooth with scattered patches of roughness), 3 = moderate (slightly rough with diffuse patches of roughness), 4 = severe (rough with diffuse areas of roughness, some scales may be visible), where the higher score indicated the worse outcome. | At Week 20 |
| Number of Participants With Severity of Skin Laxity | The evaluation of the severity of skin laxity were done by using the scale ranging from 0 to 3 that is, 0 = none (no skin laxity), 1 = mild (mild skin sagging), 2 = moderate (moderate skin sagging), 3 = severe (severe skin sagging), where the higher score indicated the worse outcome. | At Week 20 |
| Number of Participants With Tolerability Assessment of Erythema | Erythema was defined as an abnormal redness of the skin and was measured on the scale score ranging from 0 (minimum) to 3 (maximum) that is, 0 = none (no erythema),1 = mild (slight pinkness present), 2 = moderate (definite redness, easily recognized), and 3 = severe (intense redness), where the higher score indicated the worse outcome. | At Week 20 |
| Number of Participants With Tolerability Assessment of Edema | Abnormal tenseness of the skin was measured on a scale ranging from 0 to 3. 0 (none) no edema, 1 (mild) slight tenseness of skin without firmness, 2 (moderate) moderate tenseness of the skin with slight firmness, 3 (severe) severe tenseness of the skin with resistance to distortion. The higher score means the worse outcome. | At Week 20 |
| Number of Participants With Tolerability Assessment of Oozing/Crusting | Oozing/crusting was a continuing process of exudation of fluid from the lesions/formation of scab-like material on the surface of lesions resulting from dried serum. Oozing/crusting was assessed on a scale ranging from 0-3. 0 (none) no oozing/crusting, 1 (mild) faint sign of oozing and/or weeping; slight crusting on a few of the lesions, 2 (moderate) definite oozing, but not extensive (a few lesions/areas); definite crusting on several of the lesions, 3 (severe) marked oozing/weeping; heavy crusting on the majority of the lesions. The higher score indicated the worse outcome. | At Week 20 |
| Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS) | Participant skin discomfort was evaluated on a scale of 0 to 10. 0 ("no skin discomfort") to 10 ("worst possible skin discomfort") evaluation of skin discomfort (including pain and itching) on each half-face was analyzed using a VAS. The higher score indicated the worse outcome. | At Week 4 |
| Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS) | Participant skin discomfort was evaluated on a scale of 0 to 10. 0 ("no skin discomfort") to 10 ("worst possible skin discomfort") evaluation of skin discomfort (including pain and itching) on each half-face was analyzed using a VAS. The higher score indicated the worse outcome. | At Week 8 |
| Number of Participants With Tolerability Assessment of Scaling | Abnormal shedding of the stratum corneum is measured on a scale 0 to 3. 0 (none) no scaling, 1 (mild) barely perceptible shedding, noticeable only on light scratching or rubbing, 2 (moderate) obvious but not profuse shedding, 3 (severe) heavy scale production. The higher score indicated the worse outcome. | At Week 20 |
| Number of Participants With Adverse Events (AEs) | AE was defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the study drug. Abnormalities presented at Baseline were considered AEs if they reoccurred after resolution or worsen during the AE collection period. Number of participants with AEs were reported. | Up to Week 20 |
| London |
| United Kingdom |
| University of Manchester-Hope Hospital | Manchester | United Kingdom |
| BG001 | Metvix Cream 160 mg/g+Metvix Vehicle Cream (2 Hour Group) | Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm^2. The total study duration was 20 weeks. |
| BG002 | Metvix Cream 160 mg/g+Metvix Vehicle Cream (3 Hour Group) | Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm^2. The total study duration was 20 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Phototype | Skin phototype was used to describe a person's skin type. It ranges from skin phototype I to III. Where, skin phototype I = pale white skin, always burns easily, never tans; skin phototype II = fair skin, always burns easily, tans minimally and with difficulty; skin phototype III = darker white skin, burns minimally, tans gradually and uniformly. | Count of Participants | Participants |
|
| OG001 | Metvix Vehicle Cream (1 Hour Group) | Participants were topically treated with Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm^2. The total study duration was 20 weeks. |
| OG002 | Metvix Cream 160 mg/g (2 Hour Group) | Participants were topically treated with 160 mg/g Metvix cream on one half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm^2. The total study duration was 20 weeks. |
| OG003 | Metvix Vehicle Cream (2 Hour Group) | Participants were topically treated with Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm^2. The total study duration was 20 weeks. |
| OG004 | Metvix Cream 160 mg/g (3 Hour Group) | Participants were topically treated with 160 mg/g Metvix cream on one half-face at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm^2. The total study duration was 20 weeks. |
| OG005 | Metvix Vehicle Cream (3 Hour Group) | Participants were topically treated with Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm^2. The total study duration was 20 weeks. |
|
|
| Primary | Number of Participants With Severity of Mottled Hyper-Pigmentation | The evaluation of the severity of facial mottled hyperpigmentation were done using five-point scale. The score on the five-point scale ranged from 0 (minimum) to 4 (maximum), that is, 0 = none (no areas of mottled, irregular pigmentation), 1 = minimal (few, small lightly pigmented, discrete macules), 2 = mild (multiple, small lightly pigmented macules), 3 = moderate (widespread areas of mottled, moderately dark macules), 4 = severe (Widespread, multiple areas of dark macules/hyperpigmentation with uneven skin tone). The higher score indicated the worse outcome. | ITT population included all enrolled and randomized participants. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group." | Posted | Count of Participants | Participants | At Week 20 |
|
|
|
| Primary | Number of Participants With Severity of Fine Lines | The evaluation of the severity of facial fine lines were done using the five-point scale ranging from 0 to 4, that is, 0 = none- (lines disappear with stretching), 1 = minimal (few lines which do not completely disappear with stretching), 2 = mild (few lines which only diminish with stretching), 3 = moderate (widespread areas of lines which change minimally with stretching), 4 = severe- (widespread areas of lines which do not change at all with stretching), where the higher score indicated the worse outcome. | ITT population included all enrolled and randomized participants. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group." | Posted | Count of Participants | Participants | At Week 20 |
|
|
|
| Primary | Number of Participants With Severity of Telangiectasia | The severity of telangiectasia by using the scale ranging from 0 (minimum) to 3 (maximum), that is, 0 = absent (no telangiectasia), 1 = mild (slight telangiectasia characterized by appearance of a few fine, small red vessels [0.2 millimeters [mm] or less in diameter); telangiectasia covers less than 10 percent (%) of the target area, 2 = moderate (pronounced telangiectasia characterized by appearance of several fine vessels and/or few large vessels [0.2 mm or greater in diameter]; telangiectasia covers between 10 to 30% of the target area), 3 = severe (severe telangiectasia characterized by the appearance of many fine vessels and/or large vessels; telangiectasia covers greater than 30% of the target area), where the higher score indicated the worse outcome.](streamdown:incomplete-link) | ITT population included all enrolled and randomized participants. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group." | Posted | Count of Participants | Participants | At Week 20 |
|
|
|
| Primary | Number of Participants With Severity of Skin Roughness | The evaluation of the severity of skin roughness were done by using the five-point scale ranging from 0 to 4,that is, 0 = none ( very smooth, no patches of roughness), 1 = minimal (smooth with only a few patches of roughness), 2 = mild (mostly smooth with scattered patches of roughness), 3 = moderate (slightly rough with diffuse patches of roughness), 4 = severe (rough with diffuse areas of roughness, some scales may be visible), where the higher score indicated the worse outcome. | ITT population included all enrolled and randomized participants. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group." | Posted | Count of Participants | Participants | At Week 20 |
|
|
|
| Primary | Number of Participants With Severity of Skin Laxity | The evaluation of the severity of skin laxity were done by using the scale ranging from 0 to 3 that is, 0 = none (no skin laxity), 1 = mild (mild skin sagging), 2 = moderate (moderate skin sagging), 3 = severe (severe skin sagging), where the higher score indicated the worse outcome. | ITT population included all enrolled and randomized participants. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group." | Posted | Count of Participants | Participants | At Week 20 |
|
|
|
| Primary | Number of Participants With Tolerability Assessment of Erythema | Erythema was defined as an abnormal redness of the skin and was measured on the scale score ranging from 0 (minimum) to 3 (maximum) that is, 0 = none (no erythema),1 = mild (slight pinkness present), 2 = moderate (definite redness, easily recognized), and 3 = severe (intense redness), where the higher score indicated the worse outcome. | Safety population included all enrolled and randomized participants. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours." | Posted | Count of Participants | Participants | At Week 20 |
|
|
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| Primary | Number of Participants With Tolerability Assessment of Edema | Abnormal tenseness of the skin was measured on a scale ranging from 0 to 3. 0 (none) no edema, 1 (mild) slight tenseness of skin without firmness, 2 (moderate) moderate tenseness of the skin with slight firmness, 3 (severe) severe tenseness of the skin with resistance to distortion. The higher score means the worse outcome. | Safety population included all enrolled and randomized participants. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group." | Posted | Count of Participants | Participants | At Week 20 |
|
|
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| Primary | Number of Participants With Tolerability Assessment of Oozing/Crusting | Oozing/crusting was a continuing process of exudation of fluid from the lesions/formation of scab-like material on the surface of lesions resulting from dried serum. Oozing/crusting was assessed on a scale ranging from 0-3. 0 (none) no oozing/crusting, 1 (mild) faint sign of oozing and/or weeping; slight crusting on a few of the lesions, 2 (moderate) definite oozing, but not extensive (a few lesions/areas); definite crusting on several of the lesions, 3 (severe) marked oozing/weeping; heavy crusting on the majority of the lesions. The higher score indicated the worse outcome. | Safety population included all enrolled and randomized participants. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group." | Posted | Count of Participants | Participants | At Week 20 |
|
|
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| Primary | Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS) | Participant skin discomfort was evaluated on a scale of 0 to 10. 0 ("no skin discomfort") to 10 ("worst possible skin discomfort") evaluation of skin discomfort (including pain and itching) on each half-face was analyzed using a VAS. The higher score indicated the worse outcome. | Safety population included all enrolled and randomized participants. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable for this OM at given timepoint. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group." | Posted | Mean | Standard Deviation | score on a scale | At Week 4 |
|
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| Primary | Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS) | Participant skin discomfort was evaluated on a scale of 0 to 10. 0 ("no skin discomfort") to 10 ("worst possible skin discomfort") evaluation of skin discomfort (including pain and itching) on each half-face was analyzed using a VAS. The higher score indicated the worse outcome. | Safety population included all enrolled and randomized participants. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable for this OM at given timepoint. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group." | Posted | Mean | Standard Deviation | score on a scale | At Week 8 |
|
|
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| Primary | Number of Participants With Tolerability Assessment of Scaling | Abnormal shedding of the stratum corneum is measured on a scale 0 to 3. 0 (none) no scaling, 1 (mild) barely perceptible shedding, noticeable only on light scratching or rubbing, 2 (moderate) obvious but not profuse shedding, 3 (severe) heavy scale production. The higher score indicated the worse outcome. | Safety population included all enrolled and randomized participants. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned efficacy data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group." | Posted | Count of Participants | Participants | At Week 20 |
|
|
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| Primary | Number of Participants With Adverse Events (AEs) | AE was defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the study drug. Abnormalities presented at Baseline were considered AEs if they reoccurred after resolution or worsen during the AE collection period. Number of participants with AEs were reported. | Safety population included all enrolled and randomized participants. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. As per planned analysis safety data was analyzed and collected for Metvix Cream 160 mg/g+Metvix Vehicle Cream (1 Hour Group), Metvix Cream 160 mg/g+Metvix Vehicle Cream (2 Hour Group) and Metvix Cream 160 mg/g+Metvix Vehicle Cream (3 Hour Group). | Posted | Number | count of participants | Up to Week 20 |
|
|
|
| 0 |
| 11 |
| 1 |
| 11 |
| 1 |
| 11 |
| EG001 | Metvix 160 mg/g Cream+Metvix Vehicle Cream (2 Hour Group) | Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm^2. The total study duration was 20 weeks. | 0 | 9 | 1 | 9 | 3 | 9 |
| EG002 | Metvix 160 mg/g Cream+Metvix Vehicle Cream (3 Hour Group) | Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm^2. The total study duration was 20 weeks. | 0 | 12 | 0 | 12 | 8 | 12 |
| Crohn's disease | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 9.1 | Systematic Assessment |
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| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Face Injury | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Rash Pustular | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Skin Exfoliation | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
Not provided
Not provided
| Minimal |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Severe |
|
| Mild |
|
| Minimal |
|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Minimal |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Mild |
|
| Moderate |
|
| Severe |
|