Actinic Keratosis, Basal Cell Carcinoma, Bowens Disease, Squamous Cell Carcinoma, Warts
Conditions
Keywords
Non-melanoma skin cancer, Organ transplant recipients, Photodynamic therapy, Actinic keratosis
Brief summary
Participants on immunosuppressive therapy, e.g., organ recipients, had higher occurrence of AK (Actinic Keratosis) than the untreated population. Keratotic lesions (i.e., AK lesions and warts) in this population were highly associated with development of SCC (Squamous Cell Carcinoma) also with 10 times higher mortality rate because of SCC than expected. The risk of developing skin cancer, predominantly SCC and BCC (Basal Cell Carcinoma), increased with graft survival time and the length of immunosuppressive treatment period. The higher risk of developing skin malignancy and more aggressive skin malignancies in this population, indicated the need for early removal of these pre-malignant lesions. In this study, two contralateral areas (5x10 cm\^2) with skin lesions within the participant were compared. One area was received Metvix PDT at defined intervals and the other was received lesion specific treatment at the discretion of the investigator. The primary endpoint was the accumulated number of new lesions during the study and number of AK lesions that showed complete response 3 months after baseline. Secondary endpoints were number of BCC lesions that showed complete response, number of recurrent lesions, assessment of cosmetic outcome and safety.
Detailed description
The treatment area (5x10 cm\^2) was treated at baseline and at 3 ,9 and 15 months visits. At baseline, the area was treated with fractionated Metvix® PDT treatment consisting of two treatment one week apart and at 3 ,9 and 15 months visits with single Metvix® PDT treatment. The participants were evaluated for occurrence of new lesions, lesion response and recurrence at 3 (not recurrence),9,15,21, and 27 months visits. New and recurrent lesions in the treated area were treated with Metvix® PDT treatment. Lesions with partial response in the treated area were re-treated with Metvix® PDT and lesions with no response were treated with lesion specific treatment at the discretion of the investigator. In the contralateral control area (5x10 cm\^2), new and recurrent lesions and lesions in non-complete response were treated with lesion specific treatment at the discretion of the investigator at each study visit.
Interventions
PROCEDUREPhotodynamic therapy with Metvix 160 mg/g cream
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Transplant recipients with at least 2 clinically diagnosed AK lesion and maximum 10 skin lesions (AK, BCC, SCC in situ and/or warts) in each of the two contralateral areas (diameter 5x10\^2 cm) in the face, the scalp, the extremities or on the trunk/neck. * Transplant recipients who previously were treated more than once for their skin lesions. * Transplant recipients who had received immunosuppressive therapy for more than 3 years. * Males or females above 18 years of age. * Written informed consent.
Exclusion criteria
* Participants with more than 10 skin lesions (AK, BCC, SCC in situ, warts) in one of the two areas. * Participants with SCC (not SCC in situ) in one of the two areas. * Participants not previously treated or treated only once for their skin lesions. * Participants with rosacea in one of the two areas. * Participants with morphea form/highly infiltrating BCC * Known allergy to methyl-amino levulinate, a similar compound or excipients of the cream * Participation in other clinical studies either concurrently or within the last 30 days. * Pregnant or breast-feeding (all women of child-bearing potential documented a negative pregnancy test and used the pill or IUD during the treatments and for at least one month thereafter). * Conditions associated with a risk of poor protocol compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of AK Lesions That Showed Complete Response at Month 27 | At Month 27 | Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response. |
| Number of AK Lesions That Showed Complete Response at Month 3 | At Month 3 | Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response. |
| Number of AK Lesions That Showed Complete Response at Month 9 | At Month 9 | Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response. |
| Number of AK Lesions That Showed Complete Response at Month 15 | At Month 15 | Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response. |
| Number of AK Lesions That Showed Complete Response at Month 21 | At Month 21 | Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response. |
| Number of Accumulated New Skin Lesions at Month 3 | At Month 3 | A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of actinic keratoses (AK) lesions, basal cell carcinoma (BCC) lesions, squamous cell carcinoma (SCC) lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 3 were reported. |
| Number of Accumulated New Skin Lesions at Month 9 | At Month 9 | A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 9 were reported. |
| Number of Accumulated New Skin Lesions at Month 15 | At Month 15 | A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 15 were reported. |
| Number of Accumulated New Skin Lesions at Month 21 | At Month 21 | A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 21 were reported. |
| Number of Accumulated New Skin Lesions at Month 27 | At Month 27 | A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 27 were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Recurrent Lesions | At Months 9, 15, 21 and 27 | Recurrence of lesions was defined as reappearance of previously treated and eradicated lesions and was verified by histology in accordance with local hospital practice. |
| Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | At Month 27 | Overall cosmetic outcome for the two contralateral areas (treatment and contralateral control) with an area of 5 by 10 cm\^2 was assessed with regards to either absence or presence of all signs or symptoms or the presence of at least one of the signs or symptoms; scarring, atrophy, depigmentation, redness and fibrosis by both investigator and participant. Parameters were assessed for each area were hypopigmentation, hyperpigmentation, scar formation and tissue defect. The occurrence of these parameters was graded as none, slight, or obvious. Cosmetic outcome was presented as number of participants in each category (none, slight, obvious) for each variable assessed (hypopigmentation, hyperpigmentation, scar formation, tissue defect). |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Baseline up to Month 27 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Number of BCC Lesions That Showed Complete Response | At Months 3, 9, 15, 21 and 27 | Complete response was defined as the complete disappearance of the lesion. BCC lesions were characterized as superficial: ill-defined red scaly macule; could increase in size to form crusted, occasionally ulcerated, scaly erythematous patches, but never indurated and nodular: flesh-colored, cream to pink, waxy papule with prominent surface telangiectasias; as the lesions grow, central erosion or ulceration and crusting occur, surrounded by a pearly, rolled, translucent border. Number of BCC lesions that showed complete response was reported. |
Countries
Denmark, Germany, Norway, Sweden, United Kingdom
Participant flow
Recruitment details
This study was conducted at 5 countries (Denmark, Germany, Norway, Sweden, and United Kingdom) between 25 July 2003 to 14 July 2006.
Pre-assignment details
A total of 82 participants were randomized in the study, of which 81 participants were treated on one side of the participant (Treatment area) with Metvix®-PDT and other side of the participants (Contralateral Control Area).
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants were transplant recipients who had received immune suppressive therapy for at least 3 years and had skin lesions in each of two symmetrical contralateral areas on the face, scalp, extremities or trunk/neck received Metrvix®-PDT on one side of patient (treatment area) given as fractionated regimen on Week 0, Week 1, 3 months, 9 months and 15 months followed by other side of the patients selected area (Contralateral Control Area) was treated using lesion-specific treatment in accordance with the Investigator's preference. | 81 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 13 | 13 |
| Overall Study | Heavy workload, Not satisfied, Squamous Cell Carcinoma | 4 | 4 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 3 | 3 |
| Overall Study | Withdrawal by Subject | 5 | 5 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 57.3 years STANDARD_DEVIATION 10 |
| Race/Ethnicity, Customized Caucasian | 81 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 81 | 6 / 81 |
| other Total, other adverse events | 61 / 81 | 39 / 81 | 27 / 81 |
| serious Total, serious adverse events | 4 / 81 | 1 / 81 | 26 / 81 |
Outcome results
Primary
Number of Accumulated New Skin Lesions at Month 15
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 15 were reported.
Time frame: At Month 15
Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metvix®- PDT (Treatment Area) | Number of Accumulated New Skin Lesions at Month 15 | 73 new skin lesions |
| Contralateral Control Area | Number of Accumulated New Skin Lesions at Month 15 | 87 new skin lesions |
p-value: 0.118395% CI: [-0.156, 1.357]t-test, 2 sided
Primary
Number of Accumulated New Skin Lesions at Month 21
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 21 were reported.
Time frame: At Month 21
Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metvix®- PDT (Treatment Area) | Number of Accumulated New Skin Lesions at Month 21 | 55 new skin lesions |
| Contralateral Control Area | Number of Accumulated New Skin Lesions at Month 21 | 47 new skin lesions |
p-value: 0.232295% CI: [-0.323, 1.309]t-test, 2 sided
Primary
Number of Accumulated New Skin Lesions at Month 27
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 27 were reported.
Time frame: At Month 27
Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metvix®- PDT (Treatment Area) | Number of Accumulated New Skin Lesions at Month 27 | 38 new skin lesions |
| Contralateral Control Area | Number of Accumulated New Skin Lesions at Month 27 | 52 new skin lesions |
p-value: 0.128695% CI: [-0.202, 1.562]t-test, 2 sided
Primary
Number of Accumulated New Skin Lesions at Month 3
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of actinic keratoses (AK) lesions, basal cell carcinoma (BCC) lesions, squamous cell carcinoma (SCC) lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 3 were reported.
Time frame: At Month 3
Population: Intent-to-Treat (ITT) Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metvix®- PDT (Treatment Area) | Number of Accumulated New Skin Lesions at Month 3 | 65 new skin lesions |
| Contralateral Control Area | Number of Accumulated New Skin Lesions at Month 3 | 103 new skin lesions |
p-value: 0.01295% CI: [0.116, 0.911]t-test, 2 sided
Primary
Number of Accumulated New Skin Lesions at Month 9
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 9 were reported.
Time frame: At Month 9
Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metvix®- PDT (Treatment Area) | Number of Accumulated New Skin Lesions at Month 9 | 92 new skin lesions |
| Contralateral Control Area | Number of Accumulated New Skin Lesions at Month 9 | 85 new skin lesions |
p-value: 0.176195% CI: [-0.19, 1.016]t-test, 2 sided
Primary
Number of AK Lesions That Showed Complete Response at Month 15
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Time frame: At Month 15
Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metvix®- PDT (Treatment Area) | Number of AK Lesions That Showed Complete Response at Month 15 | 286 skin lesions |
| Contralateral Control Area | Number of AK Lesions That Showed Complete Response at Month 15 | 236 skin lesions |
Primary
Number of AK Lesions That Showed Complete Response at Month 21
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Time frame: At Month 21
Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metvix®- PDT (Treatment Area) | Number of AK Lesions That Showed Complete Response at Month 21 | 275 skin lesions |
| Contralateral Control Area | Number of AK Lesions That Showed Complete Response at Month 21 | 224 skin lesions |
Primary
Number of AK Lesions That Showed Complete Response at Month 27
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Time frame: At Month 27
Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metvix®- PDT (Treatment Area) | Number of AK Lesions That Showed Complete Response at Month 27 | 265 skin lesions |
| Contralateral Control Area | Number of AK Lesions That Showed Complete Response at Month 27 | 206 skin lesions |
Primary
Number of AK Lesions That Showed Complete Response at Month 3
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Time frame: At Month 3
Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metvix®- PDT (Treatment Area) | Number of AK Lesions That Showed Complete Response at Month 3 | 296 skin lesions |
| Contralateral Control Area | Number of AK Lesions That Showed Complete Response at Month 3 | 240 skin lesions |
Primary
Number of AK Lesions That Showed Complete Response at Month 9
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Time frame: At Month 9
Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metvix®- PDT (Treatment Area) | Number of AK Lesions That Showed Complete Response at Month 9 | 311 skin lesions |
| Contralateral Control Area | Number of AK Lesions That Showed Complete Response at Month 9 | 262 skin lesions |
Secondary
Number of BCC Lesions That Showed Complete Response
Complete response was defined as the complete disappearance of the lesion. BCC lesions were characterized as superficial: ill-defined red scaly macule; could increase in size to form crusted, occasionally ulcerated, scaly erythematous patches, but never indurated and nodular: flesh-colored, cream to pink, waxy papule with prominent surface telangiectasias; as the lesions grow, central erosion or ulceration and crusting occur, surrounded by a pearly, rolled, translucent border. Number of BCC lesions that showed complete response was reported.
Time frame: At Months 3, 9, 15, 21 and 27
Population: ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of BCC lesions analyzed in each Arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Metvix®- PDT (Treatment Area) | Number of BCC Lesions That Showed Complete Response | Month 15 | 0 skin lesions |
| Metvix®- PDT (Treatment Area) | Number of BCC Lesions That Showed Complete Response | Month 21 | 0 skin lesions |
| Metvix®- PDT (Treatment Area) | Number of BCC Lesions That Showed Complete Response | Month 9 | 0 skin lesions |
| Metvix®- PDT (Treatment Area) | Number of BCC Lesions That Showed Complete Response | Month 27 | 1 skin lesions |
| Metvix®- PDT (Treatment Area) | Number of BCC Lesions That Showed Complete Response | Month 3 | 1 skin lesions |
| Contralateral Control Area | Number of BCC Lesions That Showed Complete Response | Month 27 | 2 skin lesions |
| Contralateral Control Area | Number of BCC Lesions That Showed Complete Response | Month 3 | 2 skin lesions |
| Contralateral Control Area | Number of BCC Lesions That Showed Complete Response | Month 9 | 2 skin lesions |
| Contralateral Control Area | Number of BCC Lesions That Showed Complete Response | Month 21 | 2 skin lesions |
| Contralateral Control Area | Number of BCC Lesions That Showed Complete Response | Month 15 | 2 skin lesions |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: From Baseline up to Month 27
Population: Safety Population that included in the study and received Metvix® cream were included in safety evaluation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metvix®- PDT (Treatment Area) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with AE | 61 Participants |
| Metvix®- PDT (Treatment Area) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with SAE | 4 Participants |
| Contralateral Control Area | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with AE | 39 Participants |
| Contralateral Control Area | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with SAE | 1 Participants |
| Not Applicable | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with AE | 27 Participants |
| Not Applicable | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with SAE | 26 Participants |
Secondary
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants
Overall cosmetic outcome for the two contralateral areas (treatment and contralateral control) with an area of 5 by 10 cm\^2 was assessed with regards to either absence or presence of all signs or symptoms or the presence of at least one of the signs or symptoms; scarring, atrophy, depigmentation, redness and fibrosis by both investigator and participant. Parameters were assessed for each area were hypopigmentation, hyperpigmentation, scar formation and tissue defect. The occurrence of these parameters was graded as none, slight, or obvious. Cosmetic outcome was presented as number of participants in each category (none, slight, obvious) for each variable assessed (hypopigmentation, hyperpigmentation, scar formation, tissue defect).
Time frame: At Month 27
Population: ITT-population. Here, overall number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metvix®- PDT (Treatment Area) | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Hyperpigmentation (Assessor- Investigator): None | 50 Participants |
| Metvix®- PDT (Treatment Area) | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Hyperpigmentation (Assessor- Investigator): Slight/Obvious | 5 Participants |
| Metvix®- PDT (Treatment Area) | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Hyperpigmentation (Assessor- Participant): None | 51 Participants |
| Metvix®- PDT (Treatment Area) | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Hyperpigmentation (Assessor- Participant): Slight/Obvious | 3 Participants |
| Metvix®- PDT (Treatment Area) | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Hypopigmentation (Assessor- Investigator): None | 46 Participants |
| Metvix®- PDT (Treatment Area) | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Hypopigmentation (Assessor- Investigator): Slight/Obvious | 9 Participants |
| Metvix®- PDT (Treatment Area) | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Hypopigmentation (Assessor- Participant): None | 49 Participants |
| Metvix®- PDT (Treatment Area) | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Hypopigmentation (Assessor- Participant): Slight/Obvious | 5 Participants |
| Metvix®- PDT (Treatment Area) | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Scar formation (Assessor- Investigator): None | 48 Participants |
| Metvix®- PDT (Treatment Area) | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Scar formation (Assessor- Investigator): Slight/Obvious | 7 Participants |
| Metvix®- PDT (Treatment Area) | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Scar formation (Assessor- Participant: None | 47 Participants |
| Metvix®- PDT (Treatment Area) | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Scar formation (Assessor- Participant): Slight/Obvious | 7 Participants |
| Metvix®- PDT (Treatment Area) | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Tissue defect (Assessor- Investigator): None | 52 Participants |
| Metvix®- PDT (Treatment Area) | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Tissue defect (Assessor- Investigator): Slight/Obvious | 3 Participants |
| Metvix®- PDT (Treatment Area) | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Tissue defect (Assessor- Participant): None | 51 Participants |
| Metvix®- PDT (Treatment Area) | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Tissue defect (Assessor- Participant): Slight/Obvious | 3 Participants |
| Contralateral Control Area | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Scar formation (Assessor- Participant): Slight/Obvious | 14 Participants |
| Contralateral Control Area | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Hyperpigmentation (Assessor- Investigator): None | 50 Participants |
| Contralateral Control Area | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Scar formation (Assessor- Investigator): None | 42 Participants |
| Contralateral Control Area | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Hyperpigmentation (Assessor- Investigator): Slight/Obvious | 5 Participants |
| Contralateral Control Area | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Tissue defect (Assessor- Participant): Slight/Obvious | 1 Participants |
| Contralateral Control Area | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Hyperpigmentation (Assessor- Participant): None | 52 Participants |
| Contralateral Control Area | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Scar formation (Assessor- Investigator): Slight/Obvious | 13 Participants |
| Contralateral Control Area | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Hyperpigmentation (Assessor- Participant): Slight/Obvious | 2 Participants |
| Contralateral Control Area | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Tissue defect (Assessor- Participant): None | 53 Participants |
| Contralateral Control Area | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Hypopigmentation (Assessor- Investigator): None | 27 Participants |
| Contralateral Control Area | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Scar formation (Assessor- Participant: None | 40 Participants |
| Contralateral Control Area | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Hypopigmentation (Assessor- Investigator): Slight/Obvious | 28 Participants |
| Contralateral Control Area | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Tissue defect (Assessor- Investigator): Slight/Obvious | 2 Participants |
| Contralateral Control Area | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Hypopigmentation (Assessor- Participant): None | 36 Participants |
| Contralateral Control Area | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Tissue defect (Assessor- Investigator): None | 53 Participants |
| Contralateral Control Area | Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants | Hypopigmentation (Assessor- Participant): Slight/Obvious | 18 Participants |
Secondary
Number of Recurrent Lesions
Recurrence of lesions was defined as reappearance of previously treated and eradicated lesions and was verified by histology in accordance with local hospital practice.
Time frame: At Months 9, 15, 21 and 27
Population: ITT population included all participants who were enrolled and treated at baseline. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Metvix®- PDT (Treatment Area) | Number of Recurrent Lesions | Month 9 | 24 skin lesions |
| Metvix®- PDT (Treatment Area) | Number of Recurrent Lesions | Month 15 | 31 skin lesions |
| Metvix®- PDT (Treatment Area) | Number of Recurrent Lesions | Month 21 | 12 skin lesions |
| Metvix®- PDT (Treatment Area) | Number of Recurrent Lesions | Month 27 | 10 skin lesions |
| Contralateral Control Area | Number of Recurrent Lesions | Month 27 | 4 skin lesions |
| Contralateral Control Area | Number of Recurrent Lesions | Month 9 | 14 skin lesions |
| Contralateral Control Area | Number of Recurrent Lesions | Month 21 | 8 skin lesions |
| Contralateral Control Area | Number of Recurrent Lesions | Month 15 | 20 skin lesions |