Photoaged Skin
Conditions
Keywords
PDT, Photoaging, Galderma
Brief summary
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.
Detailed description
Different application times of the study treatment were being investigated.
Interventions
DRUGMetvix Cream 160 mg/g
Participants were treated with topical administration of Metvix cream.
DRUGMetvix Vehicle Group
Participants were treated with topical administration of Metvix Vehicle cream.
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female participants older than 30 years of age. * Participants with a photodamage grade of at least 4 on the Griffiths photonumeric scale (symmetrical photodamage on the two target areas) * Participants with mottled hyper-pigmentation on the face * Participants willing and capable of cooperating to the extent and degree required by the protocol * Participants must read the Patient Information Sheet and read and sign the Informed Consent form prior to any study related procedures.
Exclusion criteria
* Participants who were at risk in terms of precautions, warnings, and contra-indication in the package insert for Metvix * Participants with suspected porphyria * Participants with specific wash-out period for interfering treatments * Participants requiring concurrent treatment that would interfere with study objectives and/or evaluations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Severity of Photodamage | At Week 20 | 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. |
| Number of Participants With Severity of Mottled Hyper-Pigmentation | At Week 20 | 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. |
| Number of Participants With Severity of Fine Lines | At Week 20 | 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. |
| Number of Participants With Severity of Telangiectasia | At Week 20 | 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. |
| Number of Participants With Severity of Skin Roughness | At Week 20 | 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. |
| Number of Participants With Severity of Skin Laxity | At Week 20 | 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. |
| Number of Participants With Tolerability Assessment of Erythema | At Week 20 | 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. |
| Number of Participants With Tolerability Assessment of Edema | At Week 20 | 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. |
| Number of Participants With Tolerability Assessment of Oozing/Crusting | At Week 20 | 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. |
| Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS) | At Week 4 | 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. |
| Number of Participants With Tolerability Assessment of Scaling | At Week 20 | 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. |
| Number of Participants With Adverse Events (AEs) | Up to Week 20 | 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. |
Countries
Spain, United Kingdom
Participant flow
Recruitment details
The study was conducted at 3 centers in the United Kingdom and Spain from 18 April 2007 to 1 September 2008.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| 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. | 9 |
| 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. | 12 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Participant request | 2 | 1 | 4 |
Baseline characteristics
| Characteristic | Metvix Cream 160 mg/g+Metvix Vehicle Cream (1 Hour Group) | Metvix Cream 160 mg/g+Metvix Vehicle Cream (2 Hour Group) | Metvix Cream 160 mg/g+Metvix Vehicle Cream (3 Hour Group) | Total |
|---|---|---|---|---|
| Age, Continuous | 64.0 years STANDARD_DEVIATION 7.3 | 57.0 years STANDARD_DEVIATION 10.4 | 58.4 years STANDARD_DEVIATION 9.3 | 59.9 years STANDARD_DEVIATION 9.2 |
| Phototype Phototype I | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Phototype Phototype II | 1 Participants | 4 Participants | 3 Participants | 8 Participants |
| Phototype Phototype III | 7 Participants | 4 Participants | 8 Participants | 19 Participants |
| Race/Ethnicity, Customized Caucasian | 11 Participants | 9 Participants | 12 Participants | 32 Participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 10 Participants | 27 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 9 | 0 / 12 |
| other Total, other adverse events | 1 / 11 | 3 / 9 | 8 / 12 |
| serious Total, serious adverse events | 1 / 11 | 1 / 9 | 0 / 12 |
Outcome results
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.
Time frame: Up to Week 20
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Adverse Events (AEs) | 1 count of participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Adverse Events (AEs) | 3 count of participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Adverse Events (AEs) | 8 count of participants |
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.
Time frame: At Week 20
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Fine Lines | Minimal | 3 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Fine Lines | Severe | 1 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Fine Lines | Moderate | 3 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Fine Lines | None | 0 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Fine Lines | Mild | 2 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Fine Lines | Severe | 0 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Fine Lines | Minimal | 0 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Fine Lines | Moderate | 7 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Fine Lines | None | 0 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Fine Lines | Mild | 2 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Fine Lines | Severe | 0 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Fine Lines | Minimal | 1 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Fine Lines | None | 1 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Fine Lines | Mild | 4 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Fine Lines | Moderate | 2 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Fine Lines | Mild | 3 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Fine Lines | Moderate | 3 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Fine Lines | Severe | 1 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Fine Lines | Minimal | 1 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Fine Lines | None | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Fine Lines | Minimal | 3 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Fine Lines | Moderate | 4 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Fine Lines | None | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Fine Lines | Severe | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Fine Lines | Mild | 2 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Fine Lines | Moderate | 4 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Fine Lines | Minimal | 3 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Fine Lines | Severe | 1 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Fine Lines | None | 0 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Fine Lines | Mild | 1 Participants |
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.
Time frame: At Week 20
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Moderate | 2 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Minimal | 3 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | None | 1 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Severe | 0 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Mild | 3 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Minimal | 3 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Moderate | 2 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | None | 0 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Severe | 1 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Mild | 3 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Minimal | 3 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Moderate | 4 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Severe | 0 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Mild | 1 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | None | 0 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Mild | 3 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | None | 0 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Minimal | 2 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Moderate | 3 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Severe | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Moderate | 1 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | None | 1 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Severe | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Minimal | 5 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Mild | 2 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | None | 0 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Moderate | 3 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Minimal | 6 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Severe | 0 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Mottled Hyper-Pigmentation | Mild | 0 Participants |
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.
Time frame: At Week 20
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Photodamage | No - Mild damage | 0 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Photodamage | Mild damage | 1 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Photodamage | Mild - Moderate damage | 0 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Photodamage | Moderate damage | 3 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Photodamage | Moderate - Moderate/ severe damage | 0 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Photodamage | Moderate/ severe damage | 2 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Photodamage | Moderate/ severe - Severe damage | 1 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Photodamage | Severe damage | 2 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Photodamage | Moderate damage | 1 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Photodamage | Severe damage | 2 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Photodamage | No - Mild damage | 0 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Photodamage | Moderate/ severe - Severe damage | 1 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Photodamage | Moderate/ severe damage | 3 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Photodamage | Mild - Moderate damage | 0 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Photodamage | Mild damage | 0 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Photodamage | Moderate - Moderate/ severe damage | 2 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Photodamage | Mild damage | 0 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Photodamage | Mild - Moderate damage | 1 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Photodamage | Moderate damage | 1 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Photodamage | Severe damage | 1 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Photodamage | Moderate - Moderate/ severe damage | 2 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Photodamage | Moderate/ severe damage | 1 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Photodamage | Moderate/ severe - Severe damage | 1 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Photodamage | No - Mild damage | 1 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Photodamage | Moderate/ severe - Severe damage | 1 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Photodamage | Moderate/ severe damage | 1 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Photodamage | Moderate - Moderate/ severe damage | 3 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Photodamage | No - Mild damage | 0 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Photodamage | Mild - Moderate damage | 1 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Photodamage | Moderate damage | 0 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Photodamage | Severe damage | 1 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Photodamage | Mild damage | 1 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Photodamage | Severe damage | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Photodamage | No - Mild damage | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Photodamage | Moderate - Moderate/ severe damage | 1 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Photodamage | Moderate/ severe damage | 3 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Photodamage | Mild damage | 1 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Photodamage | Moderate/ severe - Severe damage | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Photodamage | Mild - Moderate damage | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Photodamage | Moderate damage | 4 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Photodamage | Moderate - Moderate/ severe damage | 4 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Photodamage | Severe damage | 0 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Photodamage | Mild - Moderate damage | 1 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Photodamage | Moderate damage | 2 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Photodamage | Moderate/ severe damage | 2 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Photodamage | Mild damage | 0 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Photodamage | Moderate/ severe - Severe damage | 0 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Photodamage | No - Mild damage | 0 Participants |
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.
Time frame: At Week 20
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Skin Laxity | None | 0 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Skin Laxity | Mild | 6 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Skin Laxity | Moderate | 2 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Skin Laxity | Severe | 1 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Skin Laxity | Moderate | 4 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Skin Laxity | Mild | 4 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Skin Laxity | None | 0 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Skin Laxity | Severe | 1 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Skin Laxity | Severe | 1 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Skin Laxity | Moderate | 1 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Skin Laxity | Mild | 5 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Skin Laxity | None | 1 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Skin Laxity | None | 0 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Skin Laxity | Severe | 2 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Skin Laxity | Mild | 4 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Skin Laxity | Moderate | 2 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Skin Laxity | Moderate | 4 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Skin Laxity | Severe | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Skin Laxity | Mild | 5 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Skin Laxity | None | 0 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Skin Laxity | Mild | 5 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Skin Laxity | Moderate | 3 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Skin Laxity | Severe | 1 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Skin Laxity | None | 0 Participants |
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.
Time frame: At Week 20
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Skin Roughness | Moderate | 0 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Skin Roughness | Minimal | 5 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Skin Roughness | None | 1 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Skin Roughness | Severe | 0 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Skin Roughness | Mild | 2 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Skin Roughness | Minimal | 2 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Skin Roughness | Moderate | 3 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Skin Roughness | None | 1 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Skin Roughness | Severe | 0 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Skin Roughness | Mild | 2 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Skin Roughness | Minimal | 1 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Skin Roughness | Moderate | 0 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Skin Roughness | Severe | 0 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Skin Roughness | Mild | 4 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Skin Roughness | None | 3 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Skin Roughness | Mild | 4 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Skin Roughness | None | 2 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Skin Roughness | Minimal | 1 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Skin Roughness | Moderate | 1 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Skin Roughness | Severe | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Skin Roughness | Moderate | 1 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Skin Roughness | None | 4 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Skin Roughness | Severe | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Skin Roughness | Minimal | 2 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Skin Roughness | Mild | 2 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Skin Roughness | None | 4 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Skin Roughness | Moderate | 1 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Skin Roughness | Minimal | 0 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Skin Roughness | Severe | 1 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Skin Roughness | Mild | 3 Participants |
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.
Time frame: At Week 20
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Telangiectasia | Absent | 0 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Telangiectasia | Moderate | 4 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Telangiectasia | Severe | 0 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Severity of Telangiectasia | Mild | 5 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Telangiectasia | Mild | 3 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Telangiectasia | Absent | 0 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Telangiectasia | Moderate | 6 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Severity of Telangiectasia | Severe | 0 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Telangiectasia | Moderate | 3 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Telangiectasia | Mild | 3 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Telangiectasia | Severe | 0 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Severity of Telangiectasia | Absent | 2 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Telangiectasia | Moderate | 2 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Telangiectasia | Absent | 1 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Telangiectasia | Severe | 1 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Severity of Telangiectasia | Mild | 4 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Telangiectasia | Absent | 1 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Telangiectasia | Moderate | 3 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Telangiectasia | Mild | 5 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Severity of Telangiectasia | Severe | 0 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Telangiectasia | Severe | 0 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Telangiectasia | Mild | 5 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Telangiectasia | Moderate | 4 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Severity of Telangiectasia | Absent | 0 Participants |
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.
Time frame: At Week 20
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Tolerability Assessment of Edema | None | 5 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Mild | 3 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Moderate | 0 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Severe | 1 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Moderate | 0 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Mild | 1 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Tolerability Assessment of Edema | None | 8 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Severe | 0 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Severe | 0 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Moderate | 2 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Mild | 2 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Tolerability Assessment of Edema | None | 5 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Tolerability Assessment of Edema | None | 7 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Severe | 0 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Mild | 2 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Moderate | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Moderate | 1 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Severe | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Mild | 6 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Tolerability Assessment of Edema | None | 4 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Mild | 0 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Moderate | 1 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Tolerability Assessment of Edema | Severe | 0 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Tolerability Assessment of Edema | None | 10 Participants |
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.
Time frame: At Week 20
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Moderate | 1 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Mild | 3 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Severe | 0 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | None | 5 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Mild | 1 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | None | 8 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Severe | 0 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Moderate | 0 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Mild | 5 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | None | 0 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Moderate | 4 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Severe | 0 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | None | 5 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Severe | 0 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Moderate | 2 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Mild | 2 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | None | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Severe | 1 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Moderate | 3 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Mild | 7 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Severe | 0 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Moderate | 1 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | None | 9 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Tolerability Assessment of Erythema | Mild | 1 Participants |
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.
Time frame: At Week 20
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | Mild | 1 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | None | 8 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | Moderate | 0 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | Mild | 0 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | None | 9 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | Moderate | 0 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | Mild | 2 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | None | 7 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | Moderate | 0 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | Mild | 1 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | None | 8 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | Moderate | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | Mild | 2 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | None | 6 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | Moderate | 3 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | None | 10 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | Moderate | 0 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Tolerability Assessment of Oozing/Crusting | Mild | 1 Participants |
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.
Time frame: At Week 20
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | None | 8 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Severe | 0 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Moderate | 0 Participants |
| Metvix Cream 160 mg/g (1 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Mild | 1 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Severe | 0 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Mild | 1 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | None | 8 Participants |
| Metvix Vehicle Cream (1 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Moderate | 0 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Moderate | 1 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Mild | 2 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | None | 6 Participants |
| Metvix Cream 160 mg/g (2 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Severe | 0 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Moderate | 0 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Mild | 1 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | None | 8 Participants |
| Metvix Vehicle Cream (2 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Severe | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Severe | 0 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Mild | 3 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | None | 7 Participants |
| Metvix Cream 160 mg/g (3 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Moderate | 1 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Mild | 1 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | None | 10 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Severe | 0 Participants |
| Metvix Vehicle Cream (3 Hour Group) | Number of Participants With Tolerability Assessment of Scaling | Moderate | 0 Participants |
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.
Time frame: At Week 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metvix Cream 160 mg/g (1 Hour Group) | Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS) | 3.0 score on a scale | Standard Deviation 3 |
| Metvix Vehicle Cream (1 Hour Group) | Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS) | 0 score on a scale | Standard Deviation 0 |
| Metvix Cream 160 mg/g (2 Hour Group) | Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS) | 4.6 score on a scale | Standard Deviation 2.9 |
| Metvix Vehicle Cream (2 Hour Group) | Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS) | 0.3 score on a scale | Standard Deviation 0.7 |
| Metvix Cream 160 mg/g (3 Hour Group) | Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS) | 6.3 score on a scale | Standard Deviation 2.9 |
| Metvix Vehicle Cream (3 Hour Group) | Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS) | 0.3 score on a scale | Standard Deviation 0.4 |
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.
Time frame: At Week 8
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metvix Cream 160 mg/g (1 Hour Group) | Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS) | 3.0 score on a scale | Standard Deviation 2.9 |
| Metvix Vehicle Cream (1 Hour Group) | Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS) | 0.0 score on a scale | Standard Deviation 0.1 |
| Metvix Cream 160 mg/g (2 Hour Group) | Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS) | 4.9 score on a scale | Standard Deviation 2.6 |
| Metvix Vehicle Cream (2 Hour Group) | Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS) | 0.0 score on a scale | Standard Deviation 0 |
| Metvix Cream 160 mg/g (3 Hour Group) | Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS) | 6.4 score on a scale | Standard Deviation 2.3 |
| Metvix Vehicle Cream (3 Hour Group) | Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS) | 0.2 score on a scale | Standard Deviation 0.5 |