Trial · NCT00469417
Metvix Photodynamic Therapy (PDT) Versus Cryotherapy in Participants With Primary Superficial Basal Cell Carcinoma
NCT00469417, Phase 3, Completed, Galderma R&D; results first posted 2024-08-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Metvix Photodynamic Therapy (PDT) Versus Cryotherapy in Participants With Primary Superficial Basal Cell Carcinoma. Trials, record NCT00469417. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00469417
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Metvix Photodynamic Therapy (PDT) Versus Cryotherapy in Participants With Primary Superficial Basal Cell Carcinoma
- NCT number
- NCT00469417
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 120 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Superficial Basal Cell Carcinoma
- Interventions
- Metvix® cream, Hand held liquid nitrogen spray cryotherapy
- First posted
- 2007-05-04
- Last updated
- 2024-08-19
- Results first posted
- 2024-08-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT or Cryotherapy Cycle | 3 months after last Metvix PDT or Cryotherapy cycle, up to 6 months | Patient Complete Response (CR) was defined as 100 percentage of the lesions within the participant having negative findings for nodular basal cell carcinoma (BCC) in the histological examination. |
| Secondary | Number of Lesion With Complete Response 3 Months After Last Metvix PDT or Cryotherapy Cycle | 3 months after last Metvix PDT or Cryotherapy cycle, up to 6 months | Complete response was defined as no clinically visible BCC lesions in the treatment area. |
| Secondary | Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT or Cryotherapy Cycle | 3 months after the last metvix PDT or Cryotherapy cycle (Up to 6 months) | Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as: * excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo 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 * poor: extensive occurrence of scarring, atrophy or induration. |
| Secondary | Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT or Cryotherapy Cycle | 3 months after the last metvix PDT or Cryotherapy cycle (Up to 6 months) | Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The participants graded the cosmetic outcome as: * excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo 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 * poor: extensive occurrence of scarring, atrophy or induration. |
| Secondary | Recurrence Rate in Complete Clearance Group | 12, 24, 36, 48 and 60 months after last Metvix PDT cycle or Cryotherapy (Up to 5 years) | Recurrence rate in complete clearance group was analyzed. |
| Secondary | Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT or Cryotherapy Cycle | 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle (Up to 5 years) | Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as: * excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo 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 * poor: extensive occurrence of scarring, atrophy or induration. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT or Cryotherapy Cycle | 3 months after last Metvix PDT or Cryotherapy cycle, up to 6 months | Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Number of Lesion With Complete Response 3 Months After Last Metvix PDT or Cryotherapy Cycle | 3 months after last Metvix PDT or Cryotherapy cycle, up to 6 months | Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. | lesion | NUMBER |
| SECONDARY | Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT or Cryotherapy Cycle | 3 months after the last metvix PDT or Cryotherapy cycle (Up to 6 months) | Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. Here overall Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT or Cryotherapy Cycle | 3 months after the last metvix PDT or Cryotherapy cycle (Up to 6 months) | Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. Here overall Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Recurrence Rate in Complete Clearance Group | 12, 24, 36, 48 and 60 months after last Metvix PDT cycle or Cryotherapy (Up to 5 years) | Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. Here overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | lesion | NUMBER |
| SECONDARY | Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT or Cryotherapy Cycle | 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle (Up to 5 years) | Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. Here overall Number of participants analyzed signifies those participants who were evaluable for this outcome measure. Number analyzed, signifies those participants who were evaluable for this outcome measure at the specified time point. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT or Cryotherapy Cycle | Metvix® PDT | 92 | percentage of participants | ||
| Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT or Cryotherapy Cycle | Cryotherapy | 90 | percentage of participants | ||
| Number of Lesion With Complete Response 3 Months After Last Metvix PDT or Cryotherapy Cycle | Metvix® PDT | 109 | lesion | ||
| Number of Lesion With Complete Response 3 Months After Last Metvix PDT or Cryotherapy Cycle | Cryotherapy | 94 | lesion | ||
| Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT or Cryotherapy Cycle | Metvix® PDT | Investigator: Excellent | 17 | Participants | |
| Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT or Cryotherapy Cycle | Cryotherapy | Investigator: Excellent | 2 | Participants | |
| Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT or Cryotherapy Cycle | Metvix® PDT | Investigator: Good | 30 | Participants | |
| Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT or Cryotherapy Cycle | Cryotherapy | Investigator: Good | 23 | Participants | |
| Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT or Cryotherapy Cycle | Metvix® PDT | Investigator: Fair | 6 | Participants | |
| Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT or Cryotherapy Cycle | Cryotherapy | Investigator: Fair | 25 | Participants |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metvix® PDT | 62 | |
| Overall Study | STARTED | Cryotherapy | 58 | |
| Overall Study | Treated | Metvix® PDT | 60 | |
| Overall Study | Treated | Cryotherapy | 58 | |
| Overall Study | COMPLETED | Metvix® PDT | 32 | |
| Overall Study | COMPLETED | Cryotherapy | 41 | |
| Overall Study | NOT COMPLETED | Metvix® PDT | 30 | |
| Overall Study | NOT COMPLETED | Cryotherapy | 17 |
Source ClinicalTrials.gov
Adverse events18
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 | Death due to myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Metvix® PDT | 1 | 60 | |
| serious | Death due to myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Cryotherapy | 0 | 58 | |
| serious | Cardiac arrest | Cardiac disorders | Metvix® PDT | 1 | 60 | |
| serious | Cardiac arrest | Cardiac disorders | Cryotherapy | 0 | 58 | |
| serious | Metastatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Metvix® PDT | 1 | 60 | |
| serious | Metastatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Cryotherapy | 0 | 58 | |
| serious | Participant deceased | General disorders | Metvix® PDT | 1 | 60 | |
| serious | Participant deceased | General disorders | Cryotherapy | 0 | 58 | |
| serious | Death | General disorders | Metvix® PDT | 1 | 60 | |
| serious | Death | General disorders | Cryotherapy | 0 | 58 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metvix® PDT | 4 | 60 |
| Total, all-cause mortality | Cryotherapy | 3 | 58 |
| Total, other adverse events | Metvix® PDT | 0 | 60 |
| Total, other adverse events | Cryotherapy | 0 | 58 |
| Total, serious adverse events | Metvix® PDT | 7 | 60 |
| Total, serious adverse events | Cryotherapy | 2 | 58 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Metvix® PDT vs Cryotherapy: deaths from any cause | Trial comparisons |
| Metvix® PDT vs Cryotherapy: 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/NCT00469417
GET https://conductscience.org/api/trials/v1/NCT00469417/results?page=2