Actinic Keratosis
Conditions
Keywords
Actinic Keratosis
Brief summary
Assessment of treatment success and quality of life in patients with actinic keratoses under therapy with Ingenol Mebutate (Picato) in a period of 8 weeks.
Detailed description
Non-interventional (observational) study (NIS), non-controlled, prospective cohort study.
Interventions
DRUGIngenol Mebutate
No intervention: observation of routine use of Picato®
Sponsors
LEO Pharma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Non-hyperkeratotic, non-hypertrophic actinic keratoses where treatment with Picato® is indicated and the treatment is intended by physicians.
Exclusion criteria
* Preceding use of Picato® on the area planned for treatment * Any other specific local treatment of actinic keratoses on the area planned for treatment during the last 8 weeks * Melanoma, squamous cell carcinoma or spinalioma on the area planned for treatment * Open wounds on the area planned for treatment * Contraindications according to prescribing information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Actinic keratosis | 8 weeks | Documentation of the course of actinic keratoses and skin findings during ambulant routine use of Picato® |
| Skindex-16 | 8 weeks | Patient' s quality of life during ambulant routine use of Picato® |
| Dosage of Picato® | 8 weeks | Prescribed and applied dosages and adherence during ambulant routine use of Picato® |
Countries
Germany
Outcome results
None listed