Clinical trial · Interventional
Photodynamic Therapy With PD P 506 A Compared With Placebo-PDT for the Treatment of AK
PD P 506 A or Its Placebo in Combination With Red Light for Photodynamic Therapy of Mild to Moderate Actinic Keratosis
NCT00308854CI-TRIAL-00001399completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to investigate whether PD P 506 A-PDT is effective in treating mild to moderate AK lesions located on the head.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photodynamic Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- PD P 506 A-PDT
- interventionNames
- Procedure: Photodynamic Therapy
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- Placebo-PDT
- interventionNames
- Procedure: Photodynamic Therapy
Primary outcomes (1)
- measure
- Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after PDT
- timeFrame
- 12 weeks
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Caucasian patients * Diagnosis of actinic keratosis (AK) with at least three locally separated lesions located on head and/or face (hairless areas) * Selected AK study lesions have clearly defined margins and are mild to moderate * The distance between the study lesion borders is \> 1.0 cm * Maximum diameter of each study lesion is 1.8 cm * Skin sun sensitivity type I to IV according to Fitzpatrick Exclusion Criteria: * PDT Non-responder * Pre-treatment of the AK lesions eligible for study procedures with pharmaceuticals approved for the treatment of AK during the 4 weeks preceding PDT * Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding PDT with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations * Pre-treatment with hypericin during the 2 weeks preceding PDT * Treatment with systemic retinoids during the 3 months preceding PDT * Treatment with cytostatics or radiation during the 3 months preceding PDT * Female patients of childbearing potential * Patients with clinically relevant suppression of the immune system * Diagnosis of Porphyria * Skin diseases that might interfere with response evaluation of study PDT * Skin sun sensitivity type V or VI according to Fitzpatrick * Known intolerance to one or more of the ingredients of the study medication * Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent * Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion * Suspected lack of compliance
References
Publications (0)
Data not yet available
No reference posted for this study.