Pulse-Daylight-Photodynamic Therapy of Actinic Keratoses

Phase 1

• Conditions: Actinic keratoses; MedDRA version: 18.1Level: LLTClassification code 10041304Term: Solar keratosisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-003020-31-DK
• Lead Sponsor: Department of Dermatology, Bispebjerg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-10
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Actinic keratoses in the face and scalp
Age above 18
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 20

Exclusion Criteria

Immunosuppressive treatment
MAO-inhibitor, TCA or mirtazapin/miansering/maprotilin treatment
Pregnancy
Porphyria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To reduce treatment induced erythema during photodynamic therapy;Secondary Objective: Pain during photodynamic therpy<br>Efficacy of puls-photodynamic therapy in the treatment of actinic keratoses<br>;Primary end point(s): Reduction in erythema <br>;Timepoint(s) of evaluation of this end point: 1-2 days after treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Complete lesion response rate<br>Maximal pain score;Timepoint(s) of evaluation of this end point: 3 months after treatment<br>During treatment