Photodynamic therapy with varying application times for treatment of precursors of skin cancer

Conditions: Actinic keratosis
MedDRA version: 17.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2014-002756-11-DK

Lead Sponsor: Department of Dermatology D92, Bispebjerg Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Allergy to Methyl-ALA
Decreased skin sensitivity
Pregnancy or breastfeeding
Patients not thought to be able to follow protocol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): Adverse effects:<br>Pain, scaring, hypo-hyperpigmentation, erythema, cosmetic outcome;Timepoint(s) of evaluation of this end point: Pain: during treatment<br>erythema: 1-2 days after treatment<br>scaring and hyper/hypopigmentation: 3 months after treatment<br>cosmetic outcome: 3 months after treatment