Trial · NCT00472043
PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Call Carcinoma
NCT00472043, Phase 3, Completed, Galderma R&D; results first posted 2024-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Call Carcinoma. Trials, record NCT00472043. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00472043
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Call Carcinoma
- NCT number
- NCT00472043
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 66 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Basal Cell Carcinoma
- Interventions
- PDT with Metvix 160 mg/g cream, Placebo
- First posted
- 2007-05-11
- Last updated
- 2024-08-06
- Results first posted
- 2024-08-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Histologically Confirmed Complete Response (CR) | up to 6 months | 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. 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 disappearance of lesion. Percentage of participants with histologically confirmed complete response were reported. |
| Secondary | Percentage of Lesions Per Participant: Histologically Confirmed Participant Weighted Response | Up to 3 months | Histological response weight means no signs of malignant basal cells in all microscopical slides containing excised tissue. The histologically confirmed participant weighted response, weighted by percentage of lesions per participant are reported in this outcome measure. Number of lesions per participant with-in treatment group were calculated in following way: ni = number of lesions within 1 participant, ci= number of lesions in complete response within 1 participant, xi= 100%. ci/ni= response rate within one participant, Nt= number of participant within one treatment, nt=number of lesions with-in one treatment, wi=ni/nt= weight for one participant with Nt Σ wi (i=1) = 1 for each treatment. |
| Secondary | Histological Lesion Response | Up to 3 months | Histological examination included from the excised tissue were examined for presence of malignant basal cells, where complete response (CR) was no signs of malignant basal cells and non-CR was evidence of malignant basal cells |
| Secondary | Percentage of Participants With Clinically Confirmed Participant Complete Response (CR) | Up to 9 months | A CR to treatment was documented clinically by visual evaluation and palpation. The on-site investigator evaluated the lesion response by comparing with the lesion size before treatment using the following definitions: CR - complete disappearance of a lesion. Partial response (PR) -the longest diameter of the lesion is reduced by 50% or more. No response (NR) - the longest diameter of the lesion is less than 50% reduced. Progression - the longest diameter is increased by 20% or more. |
| Secondary | Cosmetic Outcomes for Lesions Assessed by Investigator | Up to 3 months | Cosmetic outcome for those lesions with complete histological response was assessed by both the investigator and by the participant. Cosmetic outcome was assessed with regards to occurrence of the following signs or symptoms like scarring, atrophy, induration, redness, and change in pigmentation. The cosmetic outcome was graded as excellent: no scarring, atrophy or induration, and 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; poor: extensive occurrence of scarring, atrophy or induration. |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Discontinuation | Up to 6 months | An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A SAE was any untoward medical occurrence that at any dose: results in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. |
| Secondary | Cosmetic Outcomes for Lesions Assessed by Participants | Up to 3 months | Cosmetic outcome for those lesions with complete histological response was assessed by both the investigator and by the participant. Cosmetic outcome was assessed with regards to occurrence of the following signs or symptoms like scarring, atrophy, induration, redness, and change in pigmentation. The cosmetic outcome was graded as excellent: no scarring, atrophy or induration, and 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; poor: extensive occurrence of scarring, atrophy or induration. |
Source ClinicalTrials.gov
Outcomes7
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 Complete Response (CR) | up to 6 months | Intent to treat (ITT) population that included all treated participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Lesions Per Participant: Histologically Confirmed Participant Weighted Response | Up to 3 months | ITT Population that included all treated participants | Percentage of lesions per participant | MEAN |
| SECONDARY | Histological Lesion Response | Up to 3 months | ITT population included all treated participants | Lesions | COUNT_OF_UNITS |
| SECONDARY | Percentage of Participants With Clinically Confirmed Participant Complete Response (CR) | Up to 9 months | ITT population that includes all treated participants | percentage of participants | NUMBER |
| SECONDARY | Cosmetic Outcomes for Lesions Assessed by Investigator | Up to 3 months | ITT population that includes all treated participants | Lesions | NUMBER |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Discontinuation | Up to 6 months | The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cosmetic Outcomes for Lesions Assessed by Participants | Up to 3 months | ITT population that includes all treated participants | Lesions | NUMBER |
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 |
|---|---|---|---|---|---|
| Percentage of Participants With Histologically Confirmed Complete Response (CR) | Metvix® Cream 160 Milligram Per Gram | 67 | 95% Confidence Interval 48 to 82 | percentage of participants | |
| Percentage of Participants With Histologically Confirmed Complete Response (CR) | Placebo | 18 | 95% Confidence Interval 7 to 36 | percentage of participants | |
| Percentage of Lesions Per Participant: Histologically Confirmed Participant Weighted Response | Metvix® Cream 160 Milligram Per Gram | 67.6 | Standard Deviation 8.3 | Percentage of lesions per participant | |
| Percentage of Lesions Per Participant: Histologically Confirmed Participant Weighted Response | Placebo | 19.4 | Standard Deviation 6.7 | Percentage of lesions per participant | |
| Histological Lesion Response | Metvix® Cream 160 Milligram Per Gram | Lesions in CR | 23 | Lesions | |
| Histological Lesion Response | Placebo | Lesions in CR | 7 | Lesions | |
| Histological Lesion Response | Metvix® Cream 160 Milligram Per Gram | Lesions in non-CR | 8 | Lesions | |
| Histological Lesion Response | Placebo | Lesions in non-CR | 29 | Lesions | |
| Histological Lesion Response | Metvix® Cream 160 Milligram Per Gram | Missing | 3 | Lesions | |
| Histological Lesion Response | Placebo | Missing | 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 | Metvix® Cream 160 Milligram Per Gram | 33 | |
| Overall Study | STARTED | Placebo | 33 | |
| Overall Study | COMPLETED | Metvix® Cream 160 Milligram Per Gram | 31 | |
| Overall Study | COMPLETED | Placebo | 33 | |
| Overall Study | NOT COMPLETED | Metvix® Cream 160 Milligram Per Gram | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events6
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 | Carcinoma Bile Duct | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Metvix® Cream 160 Milligram Per Gram | 1 | 33 | 1 |
| serious | Carcinoma Bile Duct | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo | 0 | 33 | 0 |
| serious | Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | Metvix® Cream 160 Milligram Per Gram | 0 | 33 | 0 |
| serious | Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 33 | 1 |
| serious | Myocardial Infarction | Cardiac disorders | Metvix® Cream 160 Milligram Per Gram | 0 | 33 | 0 |
| serious | Myocardial Infarction | Cardiac disorders | Placebo | 1 | 33 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metvix® Cream 160 Milligram Per Gram | 1 | 33 |
| Total, all-cause mortality | Placebo | 0 | 33 |
| Total, other adverse events | Metvix® Cream 160 Milligram Per Gram | 0 | 33 |
| Total, other adverse events | Placebo | 0 | 33 |
| Total, serious adverse events | Metvix® Cream 160 Milligram Per Gram | 1 | 33 |
| Total, serious adverse events | Placebo | 2 | 33 |
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® Cream 160 Milligram Per Gram vs Placebo: deaths from any cause | Trial comparisons |
| Metvix® Cream 160 Milligram Per Gram vs Placebo: 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/NCT00472043
GET https://conductscience.org/api/trials/v1/NCT00472043/results?page=2