5-Fluorouracil 4% Cream Effective for Hyperkeratotic AKs

TOPLINE:

5-Fluorouracil 4% cream achieved total clearance in 54.5% and partial clearance in 24.2% of hyperkeratotic actinic keratosis (AK) lesions at 3 months, demonstrating a good safety profile with high patient tolerability.

METHODOLOGY:
 

• Researchers conducted a retrospective, single-centre study including 19 adult patients (median age, 80 years) diagnosed with clinically typical, visible, discrete, indolent hyperkeratotic AK lesions of the face or scalp between September 2024 and March 2025.
• Patients received treatment with 5-fluorouracil 4% cream once daily for 28 consecutive days. Overall, 66 hyperkeratotic AK lesions were identified, of which 38 were located on the face and 28 were located on the scalp.
• The primary efficacy outcome was the percentage of lesions with clinical complete (100%) clearance at the 3-month follow-up; the secondary outcome was the percentage of lesions with partial clearance (defined as at least a 75% reduction in lesion size and thickness).
• Local skin reactions, including erythema, scaling, oedema, crusting, erosions, stinging, and pruritus, were assessed at week 4 using a semiquantitative 0-3 scale.

TAKEAWAY:

• At the 3-month follow-up, complete clearance was achieved in 54.5% of hyperkeratotic lesions, and partial clearance was observed in 24.2% of hyperkeratotic lesions.
• Facial lesions showed better outcomes than scalp lesions, with complete clearance of 74% vs 29% (P < .001).
• Of the local skin reactions, 2.7% were severe, 47.2% were moderate, and 51.4% were mild, with erythema and stinging being reported in 89.4% and 73.6% of patients, respectively.
• 5-Fluorouracil 4% cream demonstrated consistent safety and tolerability, with none of the patients discontinuing the treatment due to adverse events.

IN PRACTICE:

“This study adds to the growing body of evidence supporting the effectiveness of 5-FU [5-fluorouracil] 4% cream in the treatment of AKs. Although data on its efficacy in treating hyperkeratotic lesions remains limited, these initial findings highlight its potential as a valuable addition to the currently poor therapeutic options for hyperkeratotic AKs,” the authors wrote.

SOURCE:

This study was led by Federica Li Pomi, Department of Precision Medicine in Medical, Surgical and Critical Care, University of Palermo, Palermo, Italy. It was published online on August 16, 2025, in Dermatology and Therapy.

LIMITATIONS:

This study was limited by the absence of a control group, which prevented direct comparisons with other treatment modalities; the small sample size, which limited statistical power; and a short follow-up, which did not allow the assessment of long-term efficacy or recurrence rates. Additionally, the lack of histopathologic confirmation of lesion clearance may have led to an overestimation of treatment success rates.

DISCLOSURES:

This study did not receive any specific funding. The authors declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.