Daylight photodynamic therapy versus cryosurgery for the treatment and prophylaxis of actinic keratoses of the face − protocol of a multicenter, prospective, randomized, controlled, two-armed study

URN to cite this document:

urn:nbn:de:bvb:355-epub-366514 Copy

DOI to cite this document:

10.5283/epub.36651 Copy

Kohl, E. ; Koller, M. ; Zeman, F. ; Szeimies, R.-M. ; Philipp-Dormston, W. G. ; Prager, W. ; Gerber, P. A. ; Karrer, S.

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License: Creative Commons Attribution 4.0 PDF - Published Version (535kB)

Date of publication of this fulltext: 30 Jan 2018 06:14

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Details

Item type:	Article
Journal or Publication Title:	BMC Dermatology
Publisher:	BioMed Central
Volume:	17
Number of Issue or Book Chapter:	1
Page Range:	pp. 1-9
Date:	25 October 2017
Institutions:	Medicine > Lehrstuhl für Dermatologie und Venerologie
Projects:	Open Access Publizieren (DFG)
Identification Number:	Value Type 10.1186/s12895-017-0064-7 DOI
Keywords:	PDT, Study protocol, Cryosurgery, Methyl aminolevulinate, Daylight, AK, Skin aging, Prevention, Photorejuvenation
Dewey Decimal Classification:	600 Technology > 610 Medical sciences Medicine
Status:	Published
Refereed:	Yes, this version has been refereed
Created at the University of Regensburg:	Yes
Item ID:	36651

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Abstract

Background Photodynamic therapy with daylight (DL-PDT) is efficacious in treating actinic keratosis (AK), but the efficacy of field-directed, repetitive DL-PDT for the treatment and prophylaxis of AK in photodamaged facial skin has not yet been investigated. Methods/design In this multicenter, prospective, randomized, controlled, two-armed, observer-blinded trial, patients with a minimum of ...

Abstract

Background
Photodynamic therapy with daylight (DL-PDT) is efficacious in treating actinic keratosis (AK), but the efficacy of field-directed, repetitive DL-PDT for the treatment and prophylaxis of AK in photodamaged facial skin has not yet been investigated.

Methods/design
In this multicenter, prospective, randomized, controlled, two-armed, observer-blinded trial, patients with a minimum of 5 mild-to-moderate AK lesions on photodamaged facial skin are randomly allocated to two treatment groups: DL-PDT with methyl aminolevulinate (MAL) and cryosurgery. In the DL-PDT group (experimental group), 5 treatments of the entire face are conducted over the course of 18 months. After preparation of the lesion and within 30 min after MAL application, patients expose themselves to daylight for 2 h. In the control group, lesion-directed cryosurgery is conducted at the first visit and, in the case of uncleared or new AK lesions, also at visits 2 to 5. The efficacy of the treatment is evaluated at visits 2 to 6 by documenting all existing and new AK lesions in the face. Cosmetic results and improvement of photoaging parameters are evaluated by means of a modified Dover scale.

Primary outcome parameter is the cumulative number of AK lesions observed between visits 2 and 6.

Secondary outcome parameters are complete clearance of AK, new AK lesions since the previous visit, cosmetic results independently evaluated by both patient and physician, patient-reported pain (visual analogue scale), patient and physician satisfaction scores with cosmetic results, and patient-reported quality of life (Dermatology Life Quality Index). Safety parameters are also documented (adverse events and serious adverse events).

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Metadata last modified: 29 Sep 2021 07:41

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