Stockfleth E, et al. - This paper dealt with a comparative contemplation of the efficacy and safety of ingenol mebutate (IngMeb) 0.015% gel with diclofenac sodium (DS) 3% gel for the treatment of actinic keratosis (AK) on the face or scalp. IngMeb illustrated substantially higher complete clearance of AK lesions (AKCLEAR 100), patient treatment satisfaction and effectiveness when compared to DS. This data exhibited the superiority of IngMeb for AK treatment on face/scalp.

Methods

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

Results

• Higher AKCLEAR 100 was reported at the end of first treatment course 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 disclosed to be higher than DS (both p<0.001).
• The application-site erythema (IngMeb 19%; DS 12%) was the most frequent AE.
• Shorter treatment-related AE (TRAE) duration was noted with IngMeb.
• The data displayed lower TRAE withdrawals for IngMeb (2%) versus DS (6%).
• TSQM scores for global satisfaction (p<0.001) and effectiveness (p=0.002) were determined as being higher with IngMeb, along with dosing instruction adherence (≥90% versus 70%).