Pretreatment with ablative fractional laser and microdermabrasion before photodynamic therapy for solar keratoses in chronically sun-damaged ski

Phase 1

Conditions: Patients over 18 years of age two similar areas with actinic keratoses and field-cancerized skin of each at least 50 cm2
MedDRA version: 19.0Level: 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: EUCTR2015-002331-18-DK

Lead Sponsor: Bispebjerg Hospital, Department of Dermatology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients over 18 years old with two similar skin areas of each 50 cm2, 5 actinic keratosis, and field-cancerization
Fertile women with negative pregnancy test and using safe contraception
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 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

porphyria
allergy to Metvix creme
infiltrating tumours in treatment area
Photodynamic therapy or laser therapy within 1 months of treatment area
pregnant or lactating women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparison of treatment efficacy of pretreatment with ablative fractional laser versus microdermabrasion combined with large-area photodynamic with methyl aminolevulinate for actinic keratoses;Secondary Objective: Local skin reactions following pretreatment with ablative fractional laser versus microdermabrasion combined with large-area photodynamic with methyl aminolevulinate for actinic keratoses;Primary end point(s): Treatment efficacy assessed as lesion complete response rate, defined as as number of actinic keratosis at 12 weeks post-treatment compared to baseline in each patient <br><br>;Timepoint(s) of evaluation of this end point: 12 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): local skin reactions after treatment evaluated as <br>acute reactions: erythema, oedema, crusting, scaling, pustules and<br>late reactions: hypopigmentation, hyperpigmentation or scars<br><br>New actinic keratoses in treatment area compared to baseline<br>Pain during laser treatment and daylight exposure<br>Cosmetic outcome assessed by patient and investigator<br>Photorejuvenation from baseline photos evaluated by investigator;Timepoint(s) of evaluation of this end point: acute skin reactions: day 1-5 after treatment<br>pain: during treatment<br>cosmetic outcome, photorejuvenation and late skin reactions:<br>12 weeks after treatment