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NCT00304239 · ClinicalTrials.gov registry record · Phase 3
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
A Phase 3 study of Actinic Keratosis, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 131
- Enrollment target
- 11
- Study locations
NCT00304239: Completed Phase 3 study of Actinic Keratosis, sponsored by Galderma R&D.
NCT00304239 is a Phase 3 study of Actinic Keratosis that has completed, run by Galderma R&D. The registered enrollment target is 131 participants, below the 181-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (28% lower). The trial reports 11 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00304239, a Phase 3 study of Actinic Keratosis, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 131 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the Light-emitting diode (LED) light source Aktilite CL128, in treatment of participants with multiple actinic keratosis (sun-damaged skin) on the face and/or scalp.
Primary Outcome
Participant complete response rate was defined as the percentage of participants with complete response. Complete response was defined as the complete disappearance of the lesion determined by clinical assessment (visual inspection and palpation) by an investigator.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Metvix-PDT
- COMBINATION_PRODUCT Vehicle-PDT
Study Locations (11)
Other
- Hautklinik Heinrich Heine Universität - Düsseldorf
- Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main - Frankfurt
- Praxis Dr. Winfried Klövekorn - Gilching
- Klinik für Dermatologie und Venerologie Universitätsklinikum Schleswig-Holstein, Campus Lübeck - Lübeck
- Klinikum der Universität München, Klinikum und Poliklinik für Dermatologie und Allergologie - München
- Klinik und Poliklinik für Dermatologie, Klinikum der Universität Regensburg - Regensburg
- Praxis Dr. Klemm - Tutzing
Illinois
- Ashish C. Bhatia - Naperville
Kentucky
- Joseph Fowler - Louisville
Oregon
- Robert T. Matheson - Portland
Texas
- Steven A. Davis - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2006-03-13 |
| Est. Completion | 2007-01-23 |
| Phase | Phase 3 |
What the finished NCT00304239 record still lists
NCT00304239 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 181-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (28% lower).
The record links to 1 condition, with Actinic Keratosis appearing as the primary indexed condition, and to 2 interventions - of which Metvix-PDT is the first listed.
NCT00304239 lists 11 locations in 5 states (Other, Illinois, Kentucky).
Frequently Asked Questions
What is clinical trial NCT00304239 about?
NCT00304239 is a clinical study titled "Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp". The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the Light-emitting diode (LED) light source Aktilite CL128, in treatment of participants with multiple actinic keratosis (sun-damaged skin) on ...
What is the current status of trial NCT00304239?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 131 participants. The study started on 2006-03-13. Estimated completion is 2007-01-23.
What conditions does trial NCT00304239 study?
This clinical trial studies the following conditions: Actinic Keratosis.
What interventions are being tested in trial NCT00304239?
The interventions under investigation include: Metvix-PDT (COMBINATION_PRODUCT), Vehicle-PDT (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT00304239?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00304239 being conducted?
This trial has 11 study locations across Illinois, Kentucky, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Actinic Keratosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00304239's enrollment target sits among peer trials
131 8th of 16 higher than 9 of 16 other Actinic Keratosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Actinic Keratosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
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-
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
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-
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up
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-
A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
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-
Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
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A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis
COMPLETED · Phase 3
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