Actinic keratosis MedDRA version: 17.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Department of Dermatology D92, Bispebjerg Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Actinic keratosis on hands 18 years or older Informed written and oral consent No nevi, tatoos or scars in the treated area Fertile women have to use safe contraceptive measures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Allergy to Methyl-ALA Decreased skin sensitivity Pregnancy or breastfeeding Patients not thought to be able to follow protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the effect of variable application times of Methyl aminolevulinat in the treatment actinic keratosis on patient´s hands.;Secondary Objective: Investigate adverse effects: Pain, scaring, hypo-hyperpigmentation, erythema, cosmetic outcome;Primary end point(s): Clearance rate 3 months after treatment. It is assessed whether the lesion is completely disappeared after treatment (complete response) or not completely disappeared (non-complete response);Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adverse effects: Pain, scaring, hypo-hyperpigmentation, erythema, cosmetic outcome;Timepoint(s) of evaluation of this end point: Pain: during treatment erythema: 1-2 days after treatment scaring and hyper/hypopigmentation: 3 months after treatment cosmetic outcome: 3 months after treatment | — |
Countries
Denmark
Contacts
Public ContactDepartment of Dermatology, D92
Bispebjerg Hospital
Outcome results
None listed