Treating actinic keratoses with natural daylight PDT: comparing two light sensitizers (ALA vs. MAL)
- Conditions
- actinic keratoses of the face or scalpMedDRA version: 16.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-002108-15-FI
- Lead Sponsor
- Mari Grönroos
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Actinic keratoses on both sides of scalp or face
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Exclusion Criteria
pregnancy
lactation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Comparing the histological and clinical efficacy of two light sensitizers in the daylight-PDT treatment of actinic keratosis;Secondary Objective: Calculating differences in cost-efficacy and assessing pain and primary treatment reaction during and after treatment;Primary end point(s): clinical and histological healing of actinic keratoses;Timepoint(s) of evaluation of this end point: 3 months after the treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): assessment of treatment reaction;Timepoint(s) of evaluation of this end point: 1 week