Clinical trial · Observational
ADL-PDT Under Routine Clinical Conditions in Patients With Actinic Keratosis
Non-interventional Study Investigating Photodynamic Therapy With Artificial Daylight Under Routine Clinical Conditions in Patients With Actinic Keratosis (ArtLight)
NCT05725213CI-TRIAL-00074319completedClinicalTrials.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 objective of this non-interventional study (NIS) is to gain comprehensive insights into the practicability of ADL-PDT with Metvix® in patients with actinic keratoses under real-world conditions.
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® 160 mg/g Creme | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Real-world applicability of the ADL-PDT
- timeFrame
- 3 months after treatment
- description
- Rate of resolved AK lesions in the focal region
Secondary outcomes (9)
- measure
- Change in skin quality over the course of the study overall and in the focus region
- timeFrame
- 3 months after treatment
- description
- Change in skin quality over the course of the study overall and in the focus region through 5 scales questionnaire. Scale from 0 (none) to 5 (strong)
- measure
- Change in AKASI score over the course of the study
- timeFrame
- 3 months after treatment
- description
- Change in AKASI score over the course of the study Scale: 0 (no AK) to 18 (AK with highest level of severity)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent to participate in the study * Age ≥18 years * Thin or non-hyperkeratotic and non-pigmented actinic keratoses (AK) on the face or scalp (Olsen grade 1 or Olsen grade 2) * The decision to undergo ADL-PDT with Metvix® was made independently of this study * No contraindication (according to the SmPC) Exclusion Criteria: * Hypersensitivity to the active substance or to one of the other ingredients listed in section 6.1 of the SmPC or other ingredients, including peanut oil, peanut or soy. * Morpheaform basal cell carcinoma * Porphyria * Pregnancy
References
Publications (1)
- BACKGROUNDKarrer S, Szeimies RM, Philipp-Dormston WG, Gerber PA, Prager W, Datz E, Zeman F, Muller K, Koller M. Repetitive Daylight Photodynamic Therapy versus Cryosurgery for Prevention of Actinic Keratoses in Photodamaged Facial Skin: A Prospective, Randomized Controlled Multicentre Two-armed Study. Acta Derm Venereol. 2021 Jan 4;101(1):adv00355. doi: 10.2340/00015555-3717. PMID 33313936