Actinic Keratosis Clinical Trial
Official title:
An Exploratory, Open-label Study of Sequential Field-directed Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
The purpose of this study is to explore the effect of treating actinic keratoses of the face with imiquimod 3.75% cream followed by photodynamic therapy in comparison to treatment with imiquimod alone
Actinic keratoses are common skin lesions associated with solar ultraviolet radiation
exposure. Some actinic keratoses may develop into skin cancers.
Imiquimod 3.75% cream is an approved treatment for actinic keratoses that utilizes a regimen
of application to the entire face or balding scalp of up to 2 packets of cream daily for two
2-week cycles, separated by a 2-week no treatment interval.
Photodynamic therapy with aminolevulinic acid (ALA) 20% topical solution is also an approved
treatment for actinic keratoses. ALA is applied to actinic keratoses, and after an
incubation period, is excited with light. Although approved as a lesion-directed treatment
for actinic keratoses, treatment of a field (e.g. face) with photodynamic therapy is
commonly performed.
Treatment with photodynamic therapy followed by imiquimod 5% cream has been reported in
patients with actinic keratoses, basal cell carcinoma and Bowen's disease, and treatment
with imiquimod 5% cream followed by photodynamic therapy in patients with vulvar
intraepithelial neoplasia. There are, however, no prior studies on the safety and/or
efficacy of using topical imiquimod 3.75% in conjunction with photodynamic therapy in the
treatment of actinic keratoses.
This study will use an open-label parallel cohort design in which all patients will received
treatment with imiquimod 3.75% cream, and subsequently will be randomized to either
photodynamic therapy or observation.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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