Trial Outcomes & Findings for Comparison of Metvix Photodynamic Therapy (PDT) With Its Vehicle in the Treatment of Photoaged Skin (NCT NCT00437320)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

At Week 20

Results posted on

2024-05-31

Participant Flow

The study was conducted at 3 centers in the United Kingdom and Spain from 18 April 2007 to 1 September 2008.

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).

Unit of analysis: Half face

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	11 11	9 9	12 12
Overall Study Metvix Cream (1 Hour)	11 11	0 0	0 0
Overall Study Metvix Vehicle Cream (1 Hour)	11 11	0 0	0 0
Overall Study Metvix Cream (2 Hour)	0 0	9 9	0 0
Overall Study Metvix Vehicle Cream (2 Hour)	0 0	9 9	0 0
Overall Study Metvix Cream (3 Hour)	0 0	0 0	12 12
Overall Study Metvix Vehicle Cream (3 Hour)	0 0	0 0	12 12
Overall Study COMPLETED	9 9	8 8	8 8
Overall Study NOT COMPLETED	2 2	1 1	4 4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Overall Study Participant request	2	1	4

Baseline Characteristics

Comparison of Metvix Photodynamic Therapy (PDT) With Its Vehicle in the Treatment of Photoaged Skin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metvix Cream 160 mg/g+Metvix Vehicle Cream (1 Hour Group) n=11 Participants 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.	Metvix Cream 160 mg/g+Metvix Vehicle Cream (2 Hour Group) n=9 Participants 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) n=12 Participants 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.	Total n=32 Participants Total of all reporting groups
Age, Continuous	64.0 years STANDARD_DEVIATION 7.3 • n=5 Participants	57.0 years STANDARD_DEVIATION 10.4 • n=7 Participants	58.4 years STANDARD_DEVIATION 9.3 • n=5 Participants	59.9 years STANDARD_DEVIATION 9.2 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	27 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	11 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	32 Participants n=4 Participants
Phototype Phototype I	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Phototype Phototype II	1 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Phototype Phototype III	7 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	19 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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."

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.

Outcome measures

Outcome measures
Measure	Metvix Cream 160 mg/g (1 Hour Group) n=9 Participants Participants were topically treated with 160 mg/g Metvix cream on one 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.	Metvix Vehicle Cream (1 Hour Group) n=9 Participants 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.	Metvix Cream 160 mg/g (2 Hour Group) n=8 Participants 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.	Metvix Vehicle Cream (2 Hour Group) n=8 Participants 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.	Metvix Cream 160 mg/g (3 Hour Group) n=9 Participants 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.	Metvix Vehicle Cream (3 Hour Group) n=9 Participants 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.
Number of Participants With Severity of Photodamage No - Mild damage	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Severity of Photodamage Mild damage	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Severity of Photodamage Mild - Moderate damage	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Severity of Photodamage Moderate damage	3 Participants	1 Participants	1 Participants	0 Participants	4 Participants	2 Participants
Number of Participants With Severity of Photodamage Moderate - Moderate/ severe damage	0 Participants	2 Participants	2 Participants	3 Participants	1 Participants	4 Participants
Number of Participants With Severity of Photodamage Moderate/ severe damage	2 Participants	3 Participants	1 Participants	1 Participants	3 Participants	2 Participants
Number of Participants With Severity of Photodamage Moderate/ severe - Severe damage	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Severity of Photodamage Severe damage	2 Participants	2 Participants	1 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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."

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.

Outcome measures

Outcome measures
Measure	Metvix Cream 160 mg/g (1 Hour Group) n=9 Participants Participants were topically treated with 160 mg/g Metvix cream on one 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.	Metvix Vehicle Cream (1 Hour Group) n=9 Participants 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.	Metvix Cream 160 mg/g (2 Hour Group) n=8 Participants 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.	Metvix Vehicle Cream (2 Hour Group) n=8 Participants 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.	Metvix Cream 160 mg/g (3 Hour Group) n=9 Participants 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.	Metvix Vehicle Cream (3 Hour Group) n=9 Participants 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.
Number of Participants With Severity of Mottled Hyper-Pigmentation None	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Severity of Mottled Hyper-Pigmentation Minimal	3 Participants	3 Participants	3 Participants	2 Participants	5 Participants	6 Participants
Number of Participants With Severity of Mottled Hyper-Pigmentation Mild	3 Participants	3 Participants	1 Participants	3 Participants	2 Participants	0 Participants
Number of Participants With Severity of Mottled Hyper-Pigmentation Moderate	2 Participants	2 Participants	4 Participants	3 Participants	1 Participants	3 Participants
Number of Participants With Severity of Mottled Hyper-Pigmentation Severe	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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."

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.

Outcome measures

Outcome measures
Measure	Metvix Cream 160 mg/g (1 Hour Group) n=9 Participants Participants were topically treated with 160 mg/g Metvix cream on one 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.	Metvix Vehicle Cream (1 Hour Group) n=9 Participants 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.	Metvix Cream 160 mg/g (2 Hour Group) n=8 Participants 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.	Metvix Vehicle Cream (2 Hour Group) n=8 Participants 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.	Metvix Cream 160 mg/g (3 Hour Group) n=9 Participants 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.	Metvix Vehicle Cream (3 Hour Group) n=9 Participants 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.
Number of Participants With Severity of Fine Lines Minimal	3 Participants	0 Participants	1 Participants	1 Participants	3 Participants	3 Participants
Number of Participants With Severity of Fine Lines Moderate	3 Participants	7 Participants	2 Participants	3 Participants	4 Participants	4 Participants
Number of Participants With Severity of Fine Lines Severe	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Severity of Fine Lines Mild	2 Participants	2 Participants	4 Participants	3 Participants	2 Participants	1 Participants
Number of Participants With Severity of Fine Lines None	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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."

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.

Outcome measures

Outcome measures
Measure	Metvix Cream 160 mg/g (1 Hour Group) n=9 Participants Participants were topically treated with 160 mg/g Metvix cream on one 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.	Metvix Vehicle Cream (1 Hour Group) n=9 Participants 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.	Metvix Cream 160 mg/g (2 Hour Group) n=8 Participants 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.	Metvix Vehicle Cream (2 Hour Group) n=8 Participants 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.	Metvix Cream 160 mg/g (3 Hour Group) n=9 Participants 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.	Metvix Vehicle Cream (3 Hour Group) n=9 Participants 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.
Number of Participants With Severity of Telangiectasia Absent	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Severity of Telangiectasia Mild	5 Participants	3 Participants	3 Participants	4 Participants	5 Participants	5 Participants
Number of Participants With Severity of Telangiectasia Moderate	4 Participants	6 Participants	3 Participants	2 Participants	3 Participants	4 Participants
Number of Participants With Severity of Telangiectasia Severe	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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."

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.

Outcome measures

Outcome measures
Measure	Metvix Cream 160 mg/g (1 Hour Group) n=8 Participants Participants were topically treated with 160 mg/g Metvix cream on one 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.	Metvix Vehicle Cream (1 Hour Group) n=8 Participants 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.	Metvix Cream 160 mg/g (2 Hour Group) n=8 Participants 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.	Metvix Vehicle Cream (2 Hour Group) n=8 Participants 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.	Metvix Cream 160 mg/g (3 Hour Group) n=9 Participants 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.	Metvix Vehicle Cream (3 Hour Group) n=9 Participants 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.
Number of Participants With Severity of Skin Roughness None	1 Participants	1 Participants	3 Participants	2 Participants	4 Participants	4 Participants
Number of Participants With Severity of Skin Roughness Minimal	5 Participants	2 Participants	1 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Severity of Skin Roughness Mild	2 Participants	2 Participants	4 Participants	4 Participants	2 Participants	3 Participants
Number of Participants With Severity of Skin Roughness Moderate	0 Participants	3 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Severity of Skin Roughness Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 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."

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.

Outcome measures

Outcome measures
Measure	Metvix Cream 160 mg/g (1 Hour Group) n=9 Participants Participants were topically treated with 160 mg/g Metvix cream on one 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.	Metvix Vehicle Cream (1 Hour Group) n=9 Participants 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.	Metvix Cream 160 mg/g (2 Hour Group) n=8 Participants 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.	Metvix Vehicle Cream (2 Hour Group) n=8 Participants 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.	Metvix Cream 160 mg/g (3 Hour Group) n=9 Participants 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.	Metvix Vehicle Cream (3 Hour Group) n=9 Participants 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.
Number of Participants With Severity of Skin Laxity Moderate	2 Participants	4 Participants	1 Participants	2 Participants	4 Participants	3 Participants
Number of Participants With Severity of Skin Laxity None	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Severity of Skin Laxity Mild	6 Participants	4 Participants	5 Participants	4 Participants	5 Participants	5 Participants
Number of Participants With Severity of Skin Laxity Severe	1 Participants	1 Participants	1 Participants	2 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 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."

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.

Outcome measures

Outcome measures
Measure	Metvix Cream 160 mg/g (1 Hour Group) n=9 Participants Participants were topically treated with 160 mg/g Metvix cream on one 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.	Metvix Vehicle Cream (1 Hour Group) n=9 Participants 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.	Metvix Cream 160 mg/g (2 Hour Group) n=9 Participants 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.	Metvix Vehicle Cream (2 Hour Group) n=9 Participants 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.	Metvix Cream 160 mg/g (3 Hour Group) n=11 Participants 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.	Metvix Vehicle Cream (3 Hour Group) n=11 Participants 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.
Number of Participants With Tolerability Assessment of Erythema None	5 Participants	8 Participants	0 Participants	5 Participants	0 Participants	9 Participants
Number of Participants With Tolerability Assessment of Erythema Mild	3 Participants	1 Participants	5 Participants	2 Participants	7 Participants	1 Participants
Number of Participants With Tolerability Assessment of Erythema Moderate	1 Participants	0 Participants	4 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Tolerability Assessment of Erythema Severe	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 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."

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.

Outcome measures

Outcome measures
Measure	Metvix Cream 160 mg/g (1 Hour Group) n=9 Participants Participants were topically treated with 160 mg/g Metvix cream on one 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.	Metvix Vehicle Cream (1 Hour Group) n=9 Participants 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.	Metvix Cream 160 mg/g (2 Hour Group) n=9 Participants 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.	Metvix Vehicle Cream (2 Hour Group) n=9 Participants 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.	Metvix Cream 160 mg/g (3 Hour Group) n=11 Participants 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.	Metvix Vehicle Cream (3 Hour Group) n=11 Participants 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.
Number of Participants With Tolerability Assessment of Edema Mild	3 Participants	1 Participants	2 Participants	2 Participants	6 Participants	0 Participants
Number of Participants With Tolerability Assessment of Edema None	5 Participants	8 Participants	5 Participants	7 Participants	4 Participants	10 Participants
Number of Participants With Tolerability Assessment of Edema Moderate	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Tolerability Assessment of Edema Severe	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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."

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.

Outcome measures

Outcome measures
Measure	Metvix Cream 160 mg/g (1 Hour Group) n=9 Participants Participants were topically treated with 160 mg/g Metvix cream on one 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.	Metvix Vehicle Cream (1 Hour Group) n=9 Participants 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.	Metvix Cream 160 mg/g (2 Hour Group) n=9 Participants 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.	Metvix Vehicle Cream (2 Hour Group) n=9 Participants 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.	Metvix Cream 160 mg/g (3 Hour Group) n=11 Participants 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.	Metvix Vehicle Cream (3 Hour Group) n=11 Participants 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.
Number of Participants With Tolerability Assessment of Oozing/Crusting None	8 Participants	9 Participants	7 Participants	8 Participants	6 Participants	10 Participants
Number of Participants With Tolerability Assessment of Oozing/Crusting Mild	1 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Tolerability Assessment of Oozing/Crusting Moderate	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants

PRIMARY outcome

Timeframe: 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."

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.

Outcome measures

Outcome measures
Measure	Metvix Cream 160 mg/g (1 Hour Group) n=9 Participants Participants were topically treated with 160 mg/g Metvix cream on one 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.	Metvix Vehicle Cream (1 Hour Group) n=9 Participants 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.	Metvix Cream 160 mg/g (2 Hour Group) n=8 Participants 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.	Metvix Vehicle Cream (2 Hour Group) n=8 Participants 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.	Metvix Cream 160 mg/g (3 Hour Group) n=10 Participants 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.	Metvix Vehicle Cream (3 Hour Group) n=10 Participants 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.
Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS)	3.0 score on a scale Standard Deviation 3.0	0 score on a scale Standard Deviation 0	4.6 score on a scale Standard Deviation 2.9	0.3 score on a scale Standard Deviation 0.7	6.3 score on a scale Standard Deviation 2.9	0.3 score on a scale Standard Deviation 0.4

PRIMARY outcome

Timeframe: 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."

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.

Outcome measures

Outcome measures
Measure	Metvix Cream 160 mg/g (1 Hour Group) n=9 Participants Participants were topically treated with 160 mg/g Metvix cream on one 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.	Metvix Vehicle Cream (1 Hour Group) n=9 Participants 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.	Metvix Cream 160 mg/g (2 Hour Group) n=8 Participants 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.	Metvix Vehicle Cream (2 Hour Group) n=8 Participants 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.	Metvix Cream 160 mg/g (3 Hour Group) n=10 Participants 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.	Metvix Vehicle Cream (3 Hour Group) n=10 Participants 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.
Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS)	3.0 score on a scale Standard Deviation 2.9	0.0 score on a scale Standard Deviation 0.1	4.9 score on a scale Standard Deviation 2.6	0.0 score on a scale Standard Deviation 0.0	6.4 score on a scale Standard Deviation 2.3	0.2 score on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: 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."

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.

Outcome measures

Outcome measures
Measure	Metvix Cream 160 mg/g (1 Hour Group) n=9 Participants Participants were topically treated with 160 mg/g Metvix cream on one 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.	Metvix Vehicle Cream (1 Hour Group) n=9 Participants 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.	Metvix Cream 160 mg/g (2 Hour Group) n=9 Participants 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.	Metvix Vehicle Cream (2 Hour Group) n=9 Participants 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.	Metvix Cream 160 mg/g (3 Hour Group) n=11 Participants 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.	Metvix Vehicle Cream (3 Hour Group) n=11 Participants 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.
Number of Participants With Tolerability Assessment of Scaling None	8 Participants	8 Participants	6 Participants	8 Participants	7 Participants	10 Participants
Number of Participants With Tolerability Assessment of Scaling Mild	1 Participants	1 Participants	2 Participants	1 Participants	3 Participants	1 Participants
Number of Participants With Tolerability Assessment of Scaling Moderate	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Tolerability Assessment of Scaling Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Metvix Cream 160 mg/g (1 Hour Group) n=11 Participants Participants were topically treated with 160 mg/g Metvix cream on one 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.	Metvix Vehicle Cream (1 Hour Group) n=9 Participants 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.	Metvix Cream 160 mg/g (2 Hour Group) n=12 Participants 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.	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.	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.	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.
Number of Participants With Adverse Events (AEs)	1 count of participants	3 count of participants	8 count of participants	—	—	—

Adverse Events

Metvix 160 mg/g Cream+Metvix Vehicle Cream (1 Hour Group)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Metvix 160 mg/g Cream+Metvix Vehicle Cream (2 Hour Group)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Metvix 160 mg/g Cream+Metvix Vehicle Cream (3 Hour Group)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Metvix 160 mg/g Cream+Metvix Vehicle Cream (1 Hour Group) n=11 participants at risk 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.	Metvix 160 mg/g Cream+Metvix Vehicle Cream (2 Hour Group) n=9 participants at risk 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 160 mg/g Cream+Metvix Vehicle Cream (3 Hour Group) n=12 participants at risk 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioma	9.1% 1/11 • Number of events 1 • 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).	0.00% 0/9 • 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).	0.00% 0/12 • 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).
Gastrointestinal disorders Crohn's disease	0.00% 0/11 • 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).	11.1% 1/9 • Number of events 1 • 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).	0.00% 0/12 • 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).

Other adverse events

Additional Information

Clinical Operations

Galderma

Phone: 817 961 5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place