Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma
Public ClinicalTrials.gov record NCT00472108. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Phase III, Double Blind Study of Photodynamic Therapy (PDT) With Metvix 160 mg/g Cream in Comparison to PDT With Placebo Cream in Patients With Primary Nodular Basal Cell Carcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00472108
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 65 participants
Conditions and interventions
Conditions
Interventions
- Photodynamic Therapy (PDT) Radiation
- Metvix cream Drug
- Placebo Cream Drug
Radiation · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2000
- Primary completion
- Mar 31, 2002
- Completion
- Mar 31, 2002
- Last update posted
- Aug 4, 2024
2000 – 2002
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Specialists Inc | Santa Monica | California | 90404-2115 | — |
| Department of Dermatology, University of Minnesota Hospital and Clinic | Minneapolis | Minnesota | 55455 | — |
| Department of Dermatology, Mayo Medical School, Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | — |
| Department of Dermatology, Roswell Park Cancer Institue | Buffalo | New York | 14263 | — |
| Northwest Cutaneous Research Specialists | Portland | Oregon | 97210 | — |
| DermResearch, Inc. | Austin | Texas | 78759 | — |
| Texas Dermatology Research Institute | Dallas | Texas | 75230 | — |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 230507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00472108, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 4, 2024 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00472108 live on ClinicalTrials.gov.