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Journal of the American Academy of Dermatology
Volume 50, n° 4
pages 563-571 (avril 2004)
Doi : 10.1016/j.jaad.2003.08.008
accepted : 27 August 2003
Chemoprevention of squamous cell carcinoma in recessive dystrophic epidermolysis bullosa: results of a phase 1 trial of systemic isotretinoin

Jo-David Fine, MD, MPH a, b, c, g, , Lorraine B Johnson, MPH, ScD a, d, e, Madeline Weiner, RN a, e, Amy Stein, MD a, e, Chirayath Suchindran, PhD f
a National Epidermolysis Bullosa Registry, Lexington, Kentucky, USA 
b Department of Medicine (Dermatology), University of Kentucky College of Medicine, Lexington, Kentucky, USA 
c Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA 
d Department of Public Health Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA 
e Department of Dermatology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA 
f Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA 
g Dermatology Associates of Kentucky, Lexington, Kentucky, USA 

*Reprint requests: Jo-David Fine, MD, MPH, Dermatology Associates of Kentucky, 250 Fountain Ct, Lexington, KY 40509, USA.

Patients with recessive dystrophic epidermolysis bullosa (RDEB) are at high risk of developing squamous cell carcinoma on or after midadolescence, and most patients die of metastatic squamous cell carcinoma within 5 years of diagnosis of their first squamous cell carcinoma.


We sought to determine whether isotretinoin can be safely administered to patients with RDEB as a possible chemopreventive agent.


A total of 20 patients with RDEB aged 15 years or older were treated daily for 8 months with isotretinoin (with a targeted dosage of 0.5 mg/kg/d).


No unusual adverse reactions were noted in this patient population. Several patients experienced reduced blistering at lower doses and increased mechanical fragility at maintenance dosage.


Isotretinoin, at least up to a dosage of 0.5 mg/kg/d, may be safely used in patients with RDEB. Although increased fragility may occur, patients tolerated this drug well and were receptive to its long-term use for possible chemoprevention of cancer. Whether such an effect will occur is yet to be proven.

The full text of this article is available in PDF format.

Abbreviations : EB, FDA, NEBR, RDEB, RDEB-HS, SCC, UNC

 Supported by federal grants from the National Institute of Arthritis, Musculoskeletal and Skin Diseases (NO1 AR72233; K24 AR02098), and the Food and Drug Administration (FD-R-001796-01) (Dr Fine, all; Dr Stein, FD-R-001796-01). Roche Laboratories, through its Investigator-Initiated Research Program, provided medication to each of our participants. A National Institutes of Health–supported General Clinical Research Center at the University of North Carolina at Chapel Hill provided resources.
Conflicts of interest: None identified.

© 2004  American Academy of Dermatology, Inc.@@#104156@@
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