Document Detail


Photodynamic therapy using aminolaevulinic acid for patients with nonhyperkeratotic actinic keratoses of the face and scalp: phase IV multicentre clinical trial with 12-month follow up.
MedLine Citation:
PMID:  17107399     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Actinic keratoses (AKs) are the most common epithelial precancerous lesions, especially among individuals with light complexions. AKs are believed to progress to in situ squamous cell carcinoma (SCC) and potentially, to invasive SCC. AKs and invasive SCCs share certain histopathological features and both share genetic tumour markers and p53 mutations. Given these facts, the treatment and management of AKs are integral components to quality dermatological health care. OBJECTIVES: Topical aminolaevulinic acid-based photodynamic therapy (ALA-PDT) has been extensively studied over the last several years. This study seeks to characterize further the efficacy and safety of ALA-PDT by extending previous work to: (i) assess the long-term recurrence rate of AKs that have resolved after ALA-PDT; (ii) to characterize the histopathology of treated AK lesions that do not completely respond to ALA-PDT or recur in long-term follow up; (iii) to characterize the histopathology of untreated clinically diagnosed AK lesions in the study population at baseline; and (iv) to evaluate ALA-PDT in darker skin types than previously studied. METHODS: Patients enrolled in this study had six to 12 discrete AK lesions, either on the face or the scalp. Individual AK lesions designated for treatment were graded as either grade 1 (lesions slightly palpable and more easily felt than seen) or grade 2 (moderately thick AKs, easily seen and felt). Patients with grade 3 (very thick and/or hyperkeratotic) lesions were excluded. For each subject, two lesions at baseline were randomized to biopsy, and were not followed as part of the study while the remaining lesions (target lesions) were treated with ALA-PDT (baseline and month 2, if required) and followed for 12 months. RESULTS: Of the 110 patients enrolled, 101 completed the study. The target AK lesions in the per-protocol population clearing completely in the first and second months following a single ALA-PDT treatment (baseline) were 76% and 72%, respectively. Sixty per cent of the patients received a second ALA-PDT treatment, limited to the target AKs still present at month 2. The percentage of treated target lesions that cleared completely peaked at 86% at month 4 then decreased gradually over time to 78% at month 12. The overall recurrence rate for all lesions that were noted to be cleared at some visit during the 12-month period was 24% (162/688). Of the 162 recurrent lesions 16 were lost to follow up, seven spontaneously cleared and 139 were biopsied. With respect to the lesions biopsied, 91% (127/139) were diagnosed histopathologically as AK, with the balance of lesions being SCC (nine of 139: 7%), basal cell carcinoma (one of 139: 0.7%) and other non-AK diagnoses (two of 139: 1%). The recurrence rate for histologically confirmed AKs was 19%. The clinical diagnosis of AK by investigators appeared to be accurate, with 91% (200/220) of the untreated clinically diagnosed AK lesions being histopathologically confirmed to be AK (AK, 142/220: 65%; advanced AK, 29/220: 13%; macular AK, 29/220: 13%). Despite concentrated efforts to recruit patients with Fitzpatrick skin types IV-VI, the distribution was as follows: I, 11%; II, 36%; III, 41%; IV, 11%; V, 2%. The demographics of this study population are typical of a patient population with AK. CONCLUSIONS: ALA-PDT was shown to be an effective and safe therapy for the treatment of AKs of the face and scalp in skin types I-V, with an acceptable rate of recurrence over 12 months of histologically confirmed AKs of 19%. Phototoxicity reactions were all expected, nonserious and had essentially resolved after 1 month post-treatment independent of skin type.
Authors:
E H Tschen; D S Wong; D M Pariser; F E Dunlap; A Houlihan; M B Ferdon;
Related Documents :
22313649 - Angiomyofibroblastoma of the vulva.
19419719 - Electric impedance spectroscopy of human atherosclerotic lesions.
21733069 - Mortierella wolfii keratomycosis in a horse.
2988479 - Electron microscopic assessment of cervical punch biopsies in women followed-up for hum...
22606579 - Spindle cell hemangioendothelioma of the temporal muscle resected with zygomatic osteot...
8760009 - Chronic irradiation enteritis: its correlation with the elapsed time interval and morph...
7277559 - T3 and t4 carcinoma of the larynx--a retrospective study.
11199669 - An overview of delayed passive eruption.
1328449 - The application of toluidine blue staining in non-gynecologic cytology.
Publication Detail:
Type:  Clinical Trial, Phase IV; Journal Article; Multicenter Study    
Journal Detail:
Title:  The British journal of dermatology     Volume:  155     ISSN:  0007-0963     ISO Abbreviation:  Br. J. Dermatol.     Publication Date:  2006 Dec 
Date Detail:
Created Date:  2006-11-19     Completed Date:  2007-05-08     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0004041     Medline TA:  Br J Dermatol     Country:  England    
Other Details:
Languages:  eng     Pagination:  1262-9     Citation Subset:  IM    
Affiliation:
Academic Dermatology Associates, Albuquerque, NM, USA.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Administration, Topical
Adult
Aged
Aged, 80 and over
Aminolevulinic Acid / therapeutic use*
Facial Dermatoses / drug therapy*,  pathology
Female
Humans
Keratosis / drug therapy*,  pathology
Male
Middle Aged
Photochemotherapy* / methods
Photosensitizing Agents / therapeutic use*
Scalp Dermatoses / drug therapy*,  pathology
Chemical
Reg. No./Substance:
0/Photosensitizing Agents; 106-60-5/Aminolevulinic Acid

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  Prospective, randomized controlled trial on Lactobacillus rhamnosus in infants with moderate to seve...
Next Document:  Cellular adhesion molecules in chronic urticaria: modulation of serum levels occurs during levocetir...