A randomized paired comparison of photodynamic therapy and topical 5-fluorouracil in the treatment of actinic keratoses.

BACKGROUND

Photodynamic therapy (PDT) has not been compared with topical 5-fluorouracil (5-FU) in the treatment of epidermal dysplasia.

OBJECTIVE

The purpose of this study was to assess the efficacy and tolerability of these two treatment modalities in 17 patients with actinic keratoses on the backs of the hands.

METHODS

Each patient's right and left hands were randomized to receive either a 3-week course of topical 5-FU applied twice per day or PDT using topical 5-aminolevulinic acid (5-ALA) and then, after 4 hours, irradiation with an incoherent light source consisting of a 1200 W metal halogen lamp emitting red light (580 to 740 nm). Each hand randomized for PDT received 150 J/cm(2). The observed median fluence rate was 86 mW/cm(2) (interquartile range, 53 to 100 mW/cm(2)). All patients were reviewed at 1, 4, and 24 weeks after starting treatment.

RESULTS

Fourteen of 17 patients (82%) completed the study. The mean lesional area treated with topical 5-FU decreased from 1390 mm(2) (standard deviation [SD], 1130) to 297 mm(2) (SD, 209). This represents a mean reduction in lesional area of 70% (confidence interval [CI], 61%-80%). The mean lesional area treated with topical PDT decreased from 1322 mm(2) (SD, 1280) to 291 mm(2) (SD, 274), representing a mean reduction in lesional area of 73% (CI, 61%-84%). The reduction in lesional area elicited by the two treatment methods was similar (CI, -25% to 17%). There was no statistically significant difference between the treatment methods in overall symptom scores for pain and redness.

CONCLUSION

One treatment with PDT using topical 5-ALA appears to be as effective and well tolerated as 3 weeks of twice-daily topical 5-FU, a cheap and widely available alternative.