Trial · NCT00472108
Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma
NCT00472108, Phase 3, Completed, Galderma R&D; results first posted 2024-08-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma. Trials, record NCT00472108. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00472108
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma
- NCT number
- NCT00472108
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 65 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Basal Cell Carcinoma
- Interventions
- Photodynamic Therapy (PDT), Metvix cream, Placebo Cream
- First posted
- 2007-05-11
- Last updated
- 2024-08-05
- Results first posted
- 2024-08-05
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Histologically Confirmed Complete Response | up to 9 months | 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. |
| Secondary | Percentage of Lesions With Histologically Confirmed Complete Lesion Response | up to 9 months | 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. |
| Secondary | Percentage of Lesions With Clinically Confirmed Complete Lesion Response | up to 9 months | 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. |
| Secondary | Histological Verified Lesions With Complete Response | up to 9 months | 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. |
| Secondary | Clinically Verified Lesions With Complete Response | up to 9 months | 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. |
| Secondary | Number of Participants With Clinically Evaluated Complete Response | up to 9 months | 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. |
| Secondary | Number of Participants With Cosmetic Outcome Assessed by Investigator and Participants | up to 9 months | 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. |
| Secondary | Number of Participants With Adverse Events and Serious Adverse Events (AEs) | up to 6 months | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Histologically Confirmed Complete Response | up to 9 months | Intent-to-treat (ITT) population included all participants who had BCC lesions and had received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Lesions With Histologically Confirmed Complete Lesion Response | up to 9 months | ITT population included all participants who had BCC lesions and had received at least one dose of study drug. | percentage of lesions | NUMBER |
| SECONDARY | Percentage of Lesions With Clinically Confirmed Complete Lesion Response | up to 9 months | ITT population included all participants who had BCC lesions and had received at least one dose of study drug. | percentage of Lesions | NUMBER |
| SECONDARY | Histological Verified Lesions With Complete Response | up to 9 months | ITT population set included all participants who had BCC lesions and received at least one dose of study drug. | Lesions | NUMBER |
| SECONDARY | Clinically Verified Lesions With Complete Response | up to 9 months | ITT population set included all participants who had BCC lesions and received at least one dose of study drug. | Lesions | NUMBER |
| SECONDARY | Number of Participants With Clinically Evaluated Complete Response | up to 9 months | ITT population set included all participants who had BCC lesions and received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Cosmetic Outcome Assessed by Investigator and Participants | up to 9 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events and Serious Adverse Events (AEs) | up to 6 months | The Safety population included all participants in the ITT who were administered at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Histologically Confirmed Complete Response | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | 25 | Participants | ||
| Number of Participants With Histologically Confirmed Complete Response | Photodynamic Therapy (PDT) With Placebo Cream | 11 | Participants | ||
| Percentage of Lesions With Histologically Confirmed Complete Lesion Response | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | 78 | percentage of lesions | ||
| Percentage of Lesions With Histologically Confirmed Complete Lesion Response | Photodynamic Therapy (PDT) With Placebo Cream | 33 | percentage of lesions | ||
| Percentage of Lesions With Clinically Confirmed Complete Lesion Response | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | 80 | percentage of Lesions | ||
| Percentage of Lesions With Clinically Confirmed Complete Lesion Response | Photodynamic Therapy (PDT) With Placebo Cream | 51 | percentage of Lesions | ||
| Histological Verified Lesions With Complete Response | Photodynamic Therapy (PDT) Metvix Cream 160 Milligram/Gram (mg/g) | 32 | Lesions | ||
| Histological Verified Lesions With Complete Response | Photodynamic Therapy (PDT) Placebo Cream | 13 | Lesions | ||
| Clinically Verified Lesions With Complete Response | Photodynamic Therapy (PDT) Metvix Cream 160 Milligram/Gram (mg/g) | 28 | Lesions | ||
| Clinically Verified Lesions With Complete Response | Photodynamic Therapy (PDT) Placebo Cream | 0 | Lesions |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | 33 | 45 |
| Overall Study | STARTED | Photodynamic Therapy (PDT) With Placebo Cream | 32 | 41 |
| Overall Study | COMPLETED | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | 33 | 41 |
| Overall Study | COMPLETED | Photodynamic Therapy (PDT) With Placebo Cream | 31 | 39 |
| Overall Study | NOT COMPLETED | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | 0 | 4 |
| Overall Study | NOT COMPLETED | Photodynamic Therapy (PDT) With Placebo Cream | 1 | 2 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Carotsid Stenosis | Vascular disorders | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | 1 | 33 | |
| serious | Carotsid Stenosis | Vascular disorders | Photodynamic Therapy (PDT) With Placebo Cream | 0 | 32 | |
| serious | Cholelithiasis | Hepatobiliary disorders | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | 0 | 33 | |
| serious | Cholelithiasis | Hepatobiliary disorders | Photodynamic Therapy (PDT) With Placebo Cream | 1 | 32 | |
| serious | Superficial femoral artery to dorsalis | Surgical and medical procedures | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | 0 | 33 | |
| serious | Superficial femoral artery to dorsalis | Surgical and medical procedures | Photodynamic Therapy (PDT) With Placebo Cream | 1 | 32 | |
| serious | Redden Ulcer and Skin | Skin and subcutaneous tissue disorders | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | 0 | 33 | |
| serious | Redden Ulcer and Skin | Skin and subcutaneous tissue disorders | Photodynamic Therapy (PDT) With Placebo Cream | 1 | 32 | |
| serious | Abdominal aneuryse - ruptured | Gastrointestinal disorders | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | 0 | 33 | |
| serious | Abdominal aneuryse - ruptured | Gastrointestinal disorders | Photodynamic Therapy (PDT) With Placebo Cream | 1 | 32 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | 0 | 33 |
| Total, all-cause mortality | Photodynamic Therapy (PDT) With Placebo Cream | 0 | 32 |
| Total, other adverse events | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | 0 | 33 |
| Total, other adverse events | Photodynamic Therapy (PDT) With Placebo Cream | 0 | 32 |
| Total, serious adverse events | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | 1 | 33 |
| Total, serious adverse events | Photodynamic Therapy (PDT) With Placebo Cream | 5 | 32 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) vs Photodynamic Therapy (PDT) With Placebo Cream: Number of Participants With Clinically Evaluated Complete Response | Trial comparisons |
| Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) vs Photodynamic Therapy (PDT) With Placebo Cream: Number of Participants With Histologically Confirmed Complete Response | Trial comparisons |
| Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) vs Photodynamic Therapy (PDT) With Placebo Cream: deaths from any cause | Trial comparisons |
| Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) vs Photodynamic Therapy (PDT) With Placebo Cream: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00472108
GET https://conductscience.org/api/trials/v1/NCT00472108/results?page=2