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Topical Tretinoin (0.1% Cream) in the Treatment of Facial Actinic Keratoses: Results of a Multicenter Study

12 August 2000


Background: Actinic Keratoses (AK) are erythematous, hyperkeratotic epidermal and pre-malignant lesions that commonly occur on aging, sun-exposed regions of the skin. These lesions, in predisposed individuals, may progress to squamous cell carcinoma. AK's frequently develop in middle-aged, fair skiIIDed caucasians following chronic overexposure to ultraviolet light. They present as multiple lesions on the face, forearms and hands,and are typically scaly and firm, measuring less than 1 cm in diameter. Current treatment of AK is limited to surgical removal, cryotherapy or topical 5-fluorouracil (5-FU). Topical Tretinoin has been tested as a single agent for the treatment of AK with favorable results. However, prior studies have failed to demonstrate a statistical significance with the use of Tretinoin compared to vehicle. Given the lack of large-scale, double blind studies, further investigation is necessary to determine its clinical utility for this condition.

Methods: 410 patients with AK completed the multi-investigational, double-blind-study in which 203 applied 0.1 % tretinoin cream, and 207 applied the vehicle to the face twice daily for 24 weeks. Patients' AK lesions were evaluated clinically throughout the study and by histological analysis of skin biopsy specimens taken before therapy and at the end of treatment.

Results: At the end of treatment the number of AK's o fthe face were reduced. There was a-55% (p

Conclusion: By clinical and histologic evaluation, 0.1 % tretinoin cream reduces the number of facial actinic keratoses with an acceptable safety profile.


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