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A randomized controlled clinical trial of topical photodynamic therapy with methyl aminolaevulinate in the treatment of actinic keratoses in transplant recipients.

AbstractBACKGROUND:
Transplant recipients have an increased propensity to develop multiple actinic keratoses, which demonstrate an increased transformation rate into invasive squamous cell carcinoma.
OBJECTIVE:
To evaluate the efficacy and tolerability of topical photodynamic therapy with the new highly tumour-selective photosensitizer methyl aminolaevulinate vs. placebo in the treatment of actinic keratoses in transplant recipients.
METHODS:
Seventeen transplant recipients with a total number of 129 mild to moderate actinic keratoses were enrolled in a prospective, randomized, double-blind, placebo-controlled study. Two lesional areas within a patient were randomized for two consecutive treatments of topical photodynamic therapy 1 week apart using either methyl aminolaevulinate or placebo cream. Sites were illuminated with 75 J cm(-2) of visible light delivered at 80 mW cm(-2) by a noncoherent light source. Complete resolution and reduction in the number or size of actinic keratoses within the lesional area relative to the initial findings were evaluated at weeks 4, 8 and 16 after treatment.
RESULTS:
The lesional areas treated with methyl aminolaevulinate were clinically cleared in 13 of 17 patients at 16 weeks. A partial response was recorded in a further three. No reduction in the size or number of actinic keratoses was observed in one area treated with methyl aminolaevulinate and in all placebo-treated areas. Adverse events, such as erythema, oedema and crust formation, were mild to moderate, and treatment was well tolerated by all patients.
CONCLUSION:
Photodynamic therapy using methyl aminolaevulinate is a safe and effective treatment for actinic keratoses in transplant recipients. It may also reduce the risk of transformation of actinic keratoses to invasive, potentially fatal, squamous cell carcinoma.
AuthorsG Dragieva, B M Prinz, J Hafner, R Dummer, G Burg, U Binswanger, W Kempf
JournalThe British journal of dermatology (Br J Dermatol) Vol. 151 Issue 1 Pg. 196-200 (Jul 2004) ISSN: 0007-0963 [Print] England
PMID15270891 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
Chemical References
  • Photosensitizing Agents
  • methyl 5-aminolevulinate
  • Aminolevulinic Acid
Topics
  • Adult
  • Aged
  • Aminolevulinic Acid (analogs & derivatives)
  • Carcinoma, Basal Cell (prevention & control)
  • Female
  • Follow-Up Studies
  • Heart Transplantation
  • Humans
  • Keratosis (drug therapy)
  • Kidney Transplantation
  • Male
  • Middle Aged
  • Photochemotherapy (methods)
  • Photosensitivity Disorders (drug therapy)
  • Photosensitizing Agents (administration & dosage, therapeutic use)
  • Postoperative Period
  • Skin Neoplasms (prevention & control)
  • Transplantation

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