actinic keratosis solar keratoses
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Age 18 years or above -Male and female -At least 5 up to 10 grade I or II AK lesions, in each of two symmetrical 50 cm2 contralateral areas, on the face or scalp, symmetrically distributed (number and severity) -Willingly to sign a written informed consent
Exclusion criteria
Exclusion criteria: -Invasive SCC, AK grade III or other tumours than AK in the area to be treated -Known allergy to MAL or related compounds, or excipients of the cream -Participation in other clinical studies in the last 30 days -Other treatments for skin cancer in the area to be treated in the last 30 days -Likelihood of noncompliance -Chronic immunosuppression -Pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: • Relapse rate of AK and incidence of new lesions at 9 months after PDT treatment • Time for new lesions to develop | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s): • Number of new lesions at 3 months and 6 months post treatment • Percentage reduction of AK from baseline at 3 months and 6 months post-treatment • At 3 months, patient side response will be categorised in one of the following categories: o Complete response: 100% of lesions within a patient-side assessed as CR o Excellent response: 75%-99% of lesions within a patient-side assessed as CR o Fair response: 50%-74% of lesions within a patient-side assessed as CR o Poor response: 25%-49 % of AK lesions within a patient-side assessed as CR o No response: 0%-24 % of AK lesions within a patient-side assessed as CR | — |
Countries
Netherlands
Outcome results
None listed