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NCT00472108 · ClinicalTrials.gov registry record · Phase 3
Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma
A Phase 3 study, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 65
- Enrollment target
NCT00472108 is a Phase 3 study that has completed, run by Galderma R&D. The registered enrollment target is 65 participants.
The verdict
NCT00472108, a Phase 3 study, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 65 participants
- Enrollment target
Study Summary
Photodynamic therapy (PDT) was the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulated more photosensitiser than normal cells. The photosensitiser generated reactive oxygen species upon illumination. For skin diseases, there had been an increasing interest in using precursors of the endogenous photosensitiser protoporphyrin IX (PpIX). The most commonly used precursors have been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix, contained the methyl ester of ALA, which penetrated the lesions well and shows high lesion selectivity. In vitro studies of animal and human tissues had shown significant intracellular formation of photoactive porphyrins after addition of Metvix. The increased photoactive porphyrins levels induced cytotoxic effects in tumour cells after photoactivation. The primary objective was to compare PDT with Metvix cream to PDT with placebo cream in terms of participants complete response rates based on histologically verified disappearance of the lesions at 6 months after last treatment cycle. Secondary objectives was to compare the two treatments in terms of histological and clinical mean participant response weighted by the number of lesions within a participant, lesion response rates across participants, clinical complete participant response, cosmetic outcome and adverse events.
Interventions
- DRUG Placebo Cream
- RADIATION Photodynamic Therapy (PDT)
- DRUG Metvix cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2000-12 |
| Est. Completion | 2002-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00472108
The ClinicalTrials.gov registry entry for NCT00472108 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Galderma R&D, which has 158 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo Cream is the first listed.
NCT00472108 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00472108 about?
NCT00472108 is a clinical study titled "Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma". Photodynamic therapy (PDT) was the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulated more photosensitiser than normal cells. The photosensitiser generated reactive oxygen species upon illumination. For skin disea...
What is the current status of trial NCT00472108?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2000-12. Estimated completion is 2002-04.
What interventions are being tested in trial NCT00472108?
The interventions under investigation include: Placebo Cream (DRUG), Photodynamic Therapy (PDT) (RADIATION), Metvix cream (DRUG).
Who is sponsoring clinical trial NCT00472108?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
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