Comparing efficacy and safety of potassium hydroxide 5% solution with 5-fluorouracil cream in patients with actinic keratoses: a randomized controlled trial

Abstract

Background

Actinic keratosis (AK) is a pre-cancerous skin lesion, associated with development of squamous cell carcinoma. Current treatment options are limited.

Objectives

To compare the efficacy and safety of topical 5-fluorouracil cream (5-FU) and potassium hydroxide 5% (KOH) in the treatment of AK.

Methods

Eighteen patients with AK applied KOH solution or 5-FU on each side of their scalp/face, randomly. The efficacy and safety of these treatments were compared.

Results

Thirteen (118 lesions) and ten (83 lesions) patients were successfully followed for one and three months, respectively. After one month, KOH showed a better clinical response (81% vs. 58%; p-value = 0.007) and dermoscopic response (KOH, 65% vs. 5-FU, 46%; p-value = 0.04); while no differences were noted after three months (clinical response, 83% vs.70%, p-value = 0.1; dermoscopic response, 76% vs. 59%, p-value = 0.1). No significant differences in the recurrence rate of the lesion between the two groups were noted at the end of the third month (p-value = 0.5). Regarding the safety of the treatments, the risk of developing erythema, scaling, sand swelling was higher in 5-FU group (p-value < 0.0001, for all), while more patients in KOH group had erosion and ulcer (p-value < 0.001 for both). KOH was up to 96% less expensive than 5-FU.

Limitations

Low number of patients and short-term follow-up limited the analysis.

Conclusion

KOH solution offers a faster and less expensive resolution of AK lesions than does 5-FU.

Clinical Trial Code (IRCT.ir)

IRCT20180909040978N1

Keywords:

• Actinic keratosis
• 5-Fluorouracil
• potassium hydroxide

Ethical approval

This work was approved by the Pharmaceutical Sciences Research Institute of Tehran University of Medical Sciences’ ethics committee (IR.TUMS.TIPS.REC.1397.010).

Disclosure statement

No potential conflict of interest was reported by the author(s).