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
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
There are no comparative study between the two types of 5% 5-FU use. So that is the purpose
of our clinical trial.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Change in Photographic Evaluation
Photographic blinded evaluation by two independent observers, comparing modifications of forearms skin overall aspect before and after 60 and 180 days of the treatments. The following 5 point scale will be used: -2=much worse; -1=worse; 0=inlatered; 1=better, 2= much better
0, 60, 180 days
Ediléia Bagatin, PhD
Brazil: National Committee of Ethics in Research