Clinical trial · Interventional
PD P 506 A-PDT Versus Placebo-PDT and Cryosurgery for the Treatment of AK
Photodynamic Therapy With PD P 506 A or Its Placebo Compared With Cryosurgery for the Treatment of Mild to Moderate Actinic Keratosis
NCT00308867CI-TRIAL-00001401completedPhase 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 how the efficacy and tolerability of PD P 506 A-PDT relate to the commonly used cryosurgery in the treatment of mild to moderate AK lesions located on the head. To be able to quantify the effect the patient will be allocated to one of three treatments: PD P 506 A-PDT, cryosurgery or placebo-PDT.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryosurgery | Procedure | — | UNRESOLVED |
| Photodynamic Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after study treatment.
- timeFrame
- 12 weeks
Secondary outcomes (4)
- measure
- CCR on patient basis 12 weeks, 6, 9 and 12 months after study treatment
- timeFrame
- 12 months
- measure
- CCR of treated actinic keratosis lesions 6, 9 and 12 months after study treatment
- timeFrame
- 12 months
- measure
- Adverse events/reactions and local reactions during application of the study medication as well as during and after study therapy (PDT or cryosurgery)
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Caucasians * Age \> 18 years * Diagnosis of actinic keratosis (AK) with at least four locally separated lesions located on head and/or face (hairless areas) * Selected AK study lesions have clearly defined margins and are mild to moderate (grades I or II) * 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 study treatment * Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding study treatment with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations * Pre-treatment with hypericin during the 2 weeks preceding study therapy * Treatment with systemic retinoids during the 3 months preceding study therapy * Treatment with cytostatics or radiation during the 3 months preceding study therapy * 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 treatment * Skin sun sensitivity type V or VI according to Fitzpatrick * Known intolerance to one or more of the ingredients of the study medication * Known adverse reactions to cryosurgery (including cold urticaria and cold intolerance) * 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.