Long-term follow-up of photodynamic therapy with a self-adhesive 5-aminolaevulinic acid patch: 12 months data.
Br J Dermatol
; 162(2): 410-4, 2010 Feb 01.
Article
en En
| MEDLINE
| ID: mdl-19804593
ABSTRACT
BACKGROUND:
Photodynamic therapy with a self-adhesive 5-aminolaevulinic acid (5-ALA) patch shows high efficacy rates in the treatment of mild to moderate actinic keratosis (AK) in short term trials.OBJECTIVES:
The purpose of the trial was to follow up patients after successful 5-ALA patch-PDT at 3 month intervals over a total period of 12 months. Patients who had received placebo-PDT or cryosurgery served for comparison. PATIENTS/METHODS:
Three months after therapy, 360 patients from two separate randomized parallel group phase III studies (one superiority trial vs. placebo-PDT, one noninferiority trial vs. cryosurgery) were suitable for the follow-up study. Patients had to show at least one successfully treated AK lesion after initial therapy. A total of 316 patients completed the follow-up.RESULTS:
Twelve months after a single treatment, 5-ALA patch-PDT still proved superior to placebo-PDT and cryosurgery (P < 0.001 for all tests). On a lesion basis, efficacy rates were 63% and 79% for PDT, 63% for cryosurgery and 9% and 25% for placebo-PDT. Recurrence rates of patch-PDT proved superior to those of cryosurgery (per protocol set P = 0.011, full analysis set P = 0.049). While 31% of cryosurgery lesions were still hypopigmented after 1 year, the 5-ALA patch-PDT groups showed hypopigmentation in 0% (superiority trial) and 3% (noninferiority trial) of the treated lesions.CONCLUSION:
Twelve months after a single 5-ALA patch-PDT the majority of lesions were still cleared with an excellent cosmetic outcome. 5-ALA patch-PDT proved to be superior to cryosurgery in the noninferiority study setting.
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Fotoquimioterapia
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Fármacos Fotosensibilizantes
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Queratosis Actínica
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Ácido Aminolevulínico
Tipo de estudio:
Clinical_trials
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Guideline
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Observational_studies
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Prognostic_studies
Límite:
Female
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Humans
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Male
Idioma:
En
Revista:
Br J Dermatol
Año:
2010
Tipo del documento:
Article
País de afiliación:
Alemania