Trial Outcomes & Findings for Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma (NCT NCT00472108)
NCT ID: NCT00472108
Last Updated: 2024-08-05
Results Overview
The histological complete response was defined as 100 percent (%) of the lesions within the participant having negative findings in the histological examination. Histological examination included evaluation of all the microscopical slides from the excised tissue for presence of malignant basal cells. Complete response was defined as complete disappearence of lesion. Number of participants with histologically confirmed complete response were reported.
COMPLETED
PHASE3
65 participants
up to 9 months
2024-08-05
Participant Flow
A total of nine centres and one dermatopathology laboratory in United States were included. Only seven of nine centres enrolled participants. Study was conducted from first participant signed informed consent: December 2000 to Last participant last visit: April 2002
Unit of analysis: Lesions
Participant milestones
| Measure |
Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g)
Participants with basal cell carcinoma (BCC) lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
Photodynamic Therapy (PDT) With Placebo Cream
Participants with BCC lesions were administered to PDT with Placebo cream applied for three hours, followed by illumination using noncoherent light with a fluency of 75 J/cm\*2 and fluency rate of 50-200 mW/cm\*2 up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
33 45
|
32 41
|
|
Overall Study
COMPLETED
|
33 41
|
31 39
|
|
Overall Study
NOT COMPLETED
|
0 4
|
1 2
|
Reasons for withdrawal
| Measure |
Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g)
Participants with basal cell carcinoma (BCC) lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
Photodynamic Therapy (PDT) With Placebo Cream
Participants with BCC lesions were administered to PDT with Placebo cream applied for three hours, followed by illumination using noncoherent light with a fluency of 75 J/cm\*2 and fluency rate of 50-200 mW/cm\*2 up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Photodynamic Therapy With Metvix Cream 160 Milligrams/Gram (mg/g)
n=33 Participants
Participants with BCC lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 J/cm\*2 and fluency rate of less than 50-200 mW/cm\*2 up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
Photodynamic Therapy (PDT) With Placebo Cream
n=32 Participants
Participants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 Years
n=5 Participants
|
67 Years
n=7 Participants
|
65 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 9 monthsPopulation: Intent-to-treat (ITT) population included all participants who had BCC lesions and had received at least one dose of study drug.
The histological complete response was defined as 100 percent (%) of the lesions within the participant having negative findings in the histological examination. Histological examination included evaluation of all the microscopical slides from the excised tissue for presence of malignant basal cells. Complete response was defined as complete disappearence of lesion. Number of participants with histologically confirmed complete response were reported.
Outcome measures
| Measure |
Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g)
n=33 Participants
Participants with basal cell carcinoma (BCC) lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
Photodynamic Therapy (PDT) With Placebo Cream
n=32 Participants
Participants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
|---|---|---|
|
Number of Participants With Histologically Confirmed Complete Response
|
25 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: up to 9 monthsPopulation: ITT population included all participants who had BCC lesions and had received at least one dose of study drug.
Histological response weight means no signs of malignant basal cells in all microscopical slides containing excised tissue. The histologically confirmed complete lesion response were reported.
Outcome measures
| Measure |
Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g)
n=41 Lesions
Participants with basal cell carcinoma (BCC) lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
Photodynamic Therapy (PDT) With Placebo Cream
n=39 Lesions
Participants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
|---|---|---|
|
Percentage of Lesions With Histologically Confirmed Complete Lesion Response
|
78 percentage of lesions
|
33 percentage of lesions
|
SECONDARY outcome
Timeframe: up to 9 monthsPopulation: ITT population included all participants who had BCC lesions and had received at least one dose of study drug.
Clinically confirmed complete lesion response means no signs of malignant basal cells in all microscopical slides containing excised tissue. The clinically confirmed complete lesion response were reported.
Outcome measures
| Measure |
Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g)
n=41 Lesions
Participants with basal cell carcinoma (BCC) lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
Photodynamic Therapy (PDT) With Placebo Cream
n=39 Lesions
Participants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
|---|---|---|
|
Percentage of Lesions With Clinically Confirmed Complete Lesion Response
|
80 percentage of Lesions
|
51 percentage of Lesions
|
SECONDARY outcome
Timeframe: up to 9 monthsPopulation: ITT population set included all participants who had BCC lesions and received at least one dose of study drug.
Histological confirmed complete lesion response means no signs of malignant basal cells in all microscopical slides containing excised tissue. Number of histologically confirmed lesions with complete response were reported.
Outcome measures
| Measure |
Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g)
n=41 Lesions
Participants with basal cell carcinoma (BCC) lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
Photodynamic Therapy (PDT) With Placebo Cream
n=39 Lesions
Participants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
|---|---|---|
|
Histological Verified Lesions With Complete Response
|
32 Lesions
|
13 Lesions
|
SECONDARY outcome
Timeframe: up to 9 monthsPopulation: ITT population set included all participants who had BCC lesions and received at least one dose of study drug.
Clinically confirmed complete lesion response means no signs of malignant basal cells in all microscopical slides containing excised tissue. Number of clinically confirmed lesions with complete response were reported.
Outcome measures
| Measure |
Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g)
n=41 Lesions
Participants with basal cell carcinoma (BCC) lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
Photodynamic Therapy (PDT) With Placebo Cream
n=39 Lesions
Participants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
|---|---|---|
|
Clinically Verified Lesions With Complete Response
|
28 Lesions
|
0 Lesions
|
SECONDARY outcome
Timeframe: up to 9 monthsPopulation: ITT population set included all participants who had BCC lesions and received at least one dose of study drug.
The on-site investigator evaluated the lesion response by comparing to the lesion size before and after treatment. Complete response here means complete disappearance of a lesion. Number of participants for whom one or more lesions had a complete response were reported.
Outcome measures
| Measure |
Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g)
n=33 Participants
Participants with basal cell carcinoma (BCC) lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
Photodynamic Therapy (PDT) With Placebo Cream
n=32 Participants
Participants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
|---|---|---|
|
Number of Participants With Clinically Evaluated Complete Response
|
28 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: up to 9 monthsPopulation: ITT population set included all participants who had BCC lesions and received at least one dose of study drug. Here, "Overall Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Number analyzed = participantswith available data for specified category.
Cosmetic outcomes were assessed with regards to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. Cosmetic outcome were graded as excellent, good, fair or poor where: excellent: no scarring, atrophy or induration, no or slight occurrence of redness or change in pigmentation compared to adjacent skin; good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin; fair: slight to moderate occurrence of scarring, atrophy or induration and Poor: extensive occurrence of scarring, atrophy or induration. The investigator and participants assessed the cosmetic outcome for each lesion has responded completely. Participants were asked to evaluate evaluate the cosmetic outcome according to the same categories: excellent, good, fair cosmetic outcome. Number of participants with summarized cosmetic outcomes for all symptoms as assessed by Investigator and participants were reported.
Outcome measures
| Measure |
Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g)
n=28 Participants
Participants with basal cell carcinoma (BCC) lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
Photodynamic Therapy (PDT) With Placebo Cream
n=10 Participants
Participants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
|---|---|---|
|
Number of Participants With Cosmetic Outcome Assessed by Investigator and Participants
Excellent: Investigator
|
17 Participants
|
5 Participants
|
|
Number of Participants With Cosmetic Outcome Assessed by Investigator and Participants
Good: Investigator
|
9 Participants
|
3 Participants
|
|
Number of Participants With Cosmetic Outcome Assessed by Investigator and Participants
Fair: Investigator
|
2 Participants
|
1 Participants
|
|
Number of Participants With Cosmetic Outcome Assessed by Investigator and Participants
Poor: Investigator
|
0 Participants
|
0 Participants
|
|
Number of Participants With Cosmetic Outcome Assessed by Investigator and Participants
Excellent: Participant
|
18 Participants
|
8 Participants
|
|
Number of Participants With Cosmetic Outcome Assessed by Investigator and Participants
Good: Participant
|
8 Participants
|
2 Participants
|
|
Number of Participants With Cosmetic Outcome Assessed by Investigator and Participants
Fair: Participant
|
2 Participants
|
0 Participants
|
|
Number of Participants With Cosmetic Outcome Assessed by Investigator and Participants
Poor: Participant
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: The Safety population included all participants in the ITT who were administered at least 1 dose of study drug.
Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs: events between first dose of study drug that were absent before treatment/that worsened relative to pre-treatment state. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with AEs and serious AEs were reported.
Outcome measures
| Measure |
Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g)
n=33 Participants
Participants with basal cell carcinoma (BCC) lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
Photodynamic Therapy (PDT) With Placebo Cream
n=32 Participants
Participants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
|---|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events (AEs)
Participants With Adverse Events (AEs)
|
30 Participants
|
24 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events (AEs)
Participants With Serious Adverse Events (AEs)
|
1 Participants
|
5 Participants
|
Adverse Events
Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g)
Photodynamic Therapy (PDT) With Placebo Cream
Serious adverse events
| Measure |
Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g)
n=33 participants at risk
Participants with basal cell carcinoma (BCC) lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
Photodynamic Therapy (PDT) With Placebo Cream
n=32 participants at risk
Participants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
|
|---|---|---|
|
Vascular disorders
Carotsid Stenosis
|
3.0%
1/33 • up to 6 months
The Safety population included all participants in the ITT who were administered at least 1 dose of study drug.
|
0.00%
0/32 • up to 6 months
The Safety population included all participants in the ITT who were administered at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/33 • up to 6 months
The Safety population included all participants in the ITT who were administered at least 1 dose of study drug.
|
3.1%
1/32 • up to 6 months
The Safety population included all participants in the ITT who were administered at least 1 dose of study drug.
|
|
Surgical and medical procedures
Superficial femoral artery to dorsalis
|
0.00%
0/33 • up to 6 months
The Safety population included all participants in the ITT who were administered at least 1 dose of study drug.
|
3.1%
1/32 • up to 6 months
The Safety population included all participants in the ITT who were administered at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Redden Ulcer and Skin
|
0.00%
0/33 • up to 6 months
The Safety population included all participants in the ITT who were administered at least 1 dose of study drug.
|
3.1%
1/32 • up to 6 months
The Safety population included all participants in the ITT who were administered at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal aneuryse - ruptured
|
0.00%
0/33 • up to 6 months
The Safety population included all participants in the ITT who were administered at least 1 dose of study drug.
|
3.1%
1/32 • up to 6 months
The Safety population included all participants in the ITT who were administered at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
New malignant melanoma
|
0.00%
0/33 • up to 6 months
The Safety population included all participants in the ITT who were administered at least 1 dose of study drug.
|
3.1%
1/32 • up to 6 months
The Safety population included all participants in the ITT who were administered at least 1 dose of study drug.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place