Phase IV head-to-head randomised controlled trial comparing ingenol mebutate 0.015% gel with diclofenac sodium 3% gel for the treatment of actinic keratosis on the face or scalp

Abstract

Background

Ingenol mebutate (IngMeb) and diclofenac sodium (DS) are approved treatments for actinic keratosis (AK).

Objectives

Compare efficacy and safety of IngMeb 0.015% gel with DS 3% gel.

Methods

Patients with 4–8 visible, discrete AK lesions on face/scalp in a 25 cm² contiguous area of skin were randomised 1:1 to IngMeb once-daily for 3 consecutive days, or DS twice-daily for 90 days, following label instruction. Patients presenting with AK lesions at Week 8 following IngMeb were offered a second IngMeb course. The primary endpoint was complete clearance of AK lesions (AKCLEAR 100) at end of first treatment course (Week 8, IngMeb; Week 17, DS). Secondary endpoints included AKCLEAR 100 at end of last treatment course and Week 17; adverse events (AEs) were assessed at these time points. Patients completed Treatment Satisfaction Questionnaires for Medication (TSQM; Week 17).

Results

AKCLEAR 100 at end of first treatment course was higher with IngMeb (34.5%) versus DS (23.5%; p=0.006). AKCLEAR 100 at end of last IngMeb course (53.3%) and Week 17 (45.1%) was higher than DS (both p<0.001). The most frequent AE was application-site erythema (IngMeb 19%; DS 12%). Treatment-related AE (TRAE) duration was shorter with IngMeb. TRAE withdrawals were lower for IngMeb (2%) versus DS (6%). TSQM scores for global satisfaction (p<0.001) and effectiveness (p=0.002) were higher with IngMeb, as was dosing instruction adherence (≥90% versus 70%).

Conclusion

AKCLEAR 100, patient treatment satisfaction and effectiveness were significantly higher with IngMeb versus DS, demonstrating superiority of IngMeb for AK treatment on face/scalp (NCT02406014).

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