Actinic Keratoses
Conditions
Brief summary
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.
Detailed description
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. Furthermore, this NIS will document the efficacy, satisfaction, safety and tolerability of ADL-PDT with Metvix® in routine use according to the label. The observational study is designed as a multicenter study, covering all parts of Germany. Participating investigators are dermatologists experienced in ADL-PDT with an adequate pool of patients with actinic keratoses. The observation time per patient will comprise up to 6 months, including up to 4 visits.
Interventions
DRUGMetvix® 160 mg/g Creme
Patients are treated with Metvix creme and exposed to artificial daylight
Sponsors
Galderma Laboratorium GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-world applicability of the ADL-PDT | 3 months after treatment | Rate of resolved AK lesions in the focal region |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in skin quality over the course of the study overall and in the focus region | 3 months after treatment | 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) |
| Change in AKASI score over the course of the study | 3 months after treatment | Change in AKASI score over the course of the study Scale: 0 (no AK) to 18 (AK with highest level of severity) |
| Change in the number of lesions over the course of the study | 3 months after treatment | Change in the number of lesions over the course of the study |
| Query of the type of skin preparation by the investigator | 3 months after treatment | Query of the type skin preparation by the investigator through questionnaire. |
| Performance of artificial daylight exposure (artificial daylight system used) | 3 months after treatment | Investigation which artificial daylight system is used through questionnaire. |
| Pain during and 5 min after artificial daylight exposure on a visual pain scale of 4 (moderate) to 10 (severe) | 3 months after treatment | Pain during and 5 min after artificial daylight exposure on a visual pain scale of 4 (moderate) to 10 (severe) |
| Occurrence of local skin irritations or adverse events | 3 months after treatment | Occurrence of local skin irritations or adverse events |
| Overall assessment of efficacy, tolerability, adherence, cosmetics by the investigator | 3 months after treatment | Overall assessment (by investigator) of efficacy, tolerability, adherence, cosmetics through 5 scales questionnaire. Scale: 1 (very good) to 5 (very unsatisfied, or no effect at all) |
| Assessment of satisfaction by the patient | 3 months after treatment | Assessment of satisfaction by the patient through questionnaire Scale: Very satisfied to very dissatisfied |
Countries
Germany
Outcome results
None listed