Clinical trial · Interventional
Clinical Evaluation of a Short Illumination Duration (35 Minutes) When Performing PDT of AK Using the Dermaris ®
Clinical Evaluation of a Short Illumination Duration (35 Minutes) When Performing Photodynamic Therapy of Actinic Keratosis Using the Dermaris ®
NCT05522036CI-TRIAL-00070570Dermaris-35completedN/AClinicalTrials.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)
This clinical study aims aims to evaluate the clinical outcomes of SDL-PDT (simulated daylight Photodynamic Therapy) using the Dermaris in patients treated for AK lesions of the scalp at our medical dermatology center using only 35 minutes low-intensity light exposure.
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 Keratoses | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metvix + Dermaris | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients treated with Methy ALA & 35 minutes white light illumination
- description
- Only patients with a minimum of 9 clinically diagnosed grade I and II AK lesions of the scalp (according to the classification by Olsen et al. suggesting the existence of field cancerization, are included in the study. All patients are informed about the purpose of the study and gave informed consent before inclusion. The illumination begins 10 min after the application of MAL cream to the treatment area. In this study, the duration of the light exposure is reduced to 35 min to achieve a PpIX-weighted daylight of 4 J/cm2. MAL cream is removed after the illumination procedure leading to an incubation time of 45 min.
- interventionNames
- Combination Product: Metvix + Dermaris
Primary outcomes (1)
- measure
- Lesion clearance rate
- timeFrame
- 1 year
- description
- The number of removed lesions at six-month post treatment will be expressed as percentage: number of removed lesions divided by number of lesions at patients' inclusion.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * phototype 1 to 3, * grade I-II AK of the scalp * minimum of 9 clinically diagnosed grade I and II AK lesions of the scalp (according to the classification of Olsen) suggesting the existence of field cancerization Exclusion Criteria: * serious organic disorder, * incipient or established cognitive impairment * pregnancy * lactation, * to be receiving oral or parenteral pharmacological therapy which might interfere with the results.
References
Publications (1)
- RESULTCreusot M, Mordon S. Clinical evaluation of a short illumination duration (1 hour) when performing photodynamic therapy of actinic keratosis using the Dermaris light source. Photodiagnosis Photodyn Ther. 2021 Dec;36:102618. doi: 10.1016/j.pdpdt.2021.102618. Epub 2021 Nov 4. PMID 34743007