Nine studies (n=841 participants) were included in the review. Seven studies were described as RCTs, one was a controlled clinical trial and one was a comparative study. Four studies were double-blind.
For 0.5% 5-fluorouracil the rate of complete clearance ranged from 14.9% (one week post treatment) to 57.8% (four weeks post treatment). For 5% 5-fluorouracil, complete clearance rates ranged from 43% (four weeks post treatment) to 100% (two weeks post treatment).
One RCT (n=21) that provided a direct comparison between 0.5% and 5% 5-fluorouracil demonstrated equivalent complete clearance rates (43%) and a higher rate of facial irritation for 5% 5-fluorouracil.
Adverse events included erythema, pain and burning, mild to moderate facial irritation and other application site reactions. Use of various measures of tolerability precluded comparisons of adverse events between the two treatment regimens.