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Brief Title: 5fluorouracil for Advanced Photoaging
Official Title: Phase III Comparative Study About the Use of 5% 5-fluorouracil Cream Versus Its Utilization as Agent for Sequential Superficial Peeling in the Treatment of Advanced Photoaging
Study ID: NCT01405144
Brief Summary: It is well known the efficacy of 5% 5-fluoruracil for multiple and superficial actinic keratosis (AKs)treatment. Recently its additional benefit for advanced and severe photoaging while treating Aks was reported. The aim of this study is to compare the efficacy and safety of the two modalities of 5% 5-FU use for forearms photoaging.
Detailed Description: The use of 5% 5-fluorouracil (5-FU) cream, twice a day, during 3 weeks represents a classic treatment for multiple and superficial AKs. The main adverse event is the severe skin irritation leading to interruption of the treatment in some cases. In the last decade a superficial pulse-peeling using it as agent in sequential applications was described. This modality of treatment has been demonstrated efficacy and better tolerability. The improvement of the overall aspect of photodamaged skin is observed while treating multiple AKs. There are no comparative study between the two types of 5% 5-FU use. So that is the purpose of our clinical trial.
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Edileia Bagatin, Sao Paulo, SP, Brazil
Name: Ediléia Bagatin, PhD
Affiliation: Professor
Role: STUDY_CHAIR