A Single-Arm, Open-Label, Phase IV Study to Evaluate the Efficacy of a Topical Formulation for Hyperkeratotic Actinic Keratosis Lesions

Abstract

Introduction

Actinic keratosis (AKs) are epidermal lesions that commonly occur in skin exposed to chronic cumulative UV irradiation. Untreated AK lesions can advance to squamous cell carcinoma. Current treatments of AK have many shortcomings; for instance, not all treatments can be used for the hyperkeratotic form of AK. The aim of this study was to test the efficacy and tolerability of a topical product containing 2,4,6-octatrienoic acid and urea for the treatment of hyperkeratotic AK lesions.

Methods

Forty male and female subjects with at least two hyperkeratotic AK lesions were enrolled in this single-arm, open-label phase IV study. The product was applied twice daily for two consecutive months. The efficacy endpoints were the reductions in the mean number of AK lesions per subject from baseline (T0) to the end of the trial (T1) and to three months after the end of the treatment period (T2).

Results

At T0, the mean (SD) number of lesions per subject was 3.65 (1.25). At the end of the treatment period (T1), this number had dropped (significantly, p < 0.0001) by 83.56%. The mean number of lesions per subject then decreased by 41.47% (p < 0.0001) between T1 and the three-month follow-up visit (T2). Complete elimination of lesions had occurred in 57.5% of the subjects at T1, and 82.5% (55% who had remained completely clear of lesions since T1, and 27.5% who had fully eliminated their lesions during the period from T1 to T2) at T2. No side effects were reported.

Conclusion

The application of a topical combination of 2,4,6-octatrienoic acid and urea twice daily for 60 consecutive days is a safe and effective treatment for hyperkeratotic AK lesions.

Funding

Giuliani SpA.

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