KOH 5% solution versus diclofenac 3% for the treatment of actinic keratosis - Results from a three-armed RCT.
Summary
In a three-armed RCT (n=631), 5% KOH solution achieved higher patient-level complete clearance than diclofenac 3% gel and placebo, with faster onset and similar tolerability. Individual-lesion clearance was also superior with KOH, and safety events were mostly mild and localized.
Key Findings
- Treatment success (patient-level complete clearance) was 45.2% with KOH vs 23.8% with diclofenac and 22.9% with placebo.
- Individual-lesion complete remission was higher with KOH (65.0%) than diclofenac (45.9%) or placebo (39.9%).
- Faster onset: 1-month complete clearance 16.0% (KOH) vs 9.2% (diclofenac); safety was mostly mild localized reactions with similar tolerability.
Clinical Implications
KOH 5% can be considered a first-line, lesion-directed option for mild-to-moderate AK (actinic keratosis) in primary care, offering faster onset and comparable tolerability to diclofenac.
Why It Matters
This large, registered RCT provides high-level evidence supporting a simple, lesion-directed topical therapy that outperforms a commonly used standard for early-stage actinic keratosis.
Limitations
- Diclofenac arm was investigator-blinded rather than fully double-blinded
- Study focused on mild-to-moderate AK; longer-term outcomes beyond 6 months were not fully characterized
Future Directions
Head-to-head comparisons with other field therapies, cost-effectiveness analyses, and durability of clearance beyond 12 months are warranted.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized controlled trial providing high-level evidence of efficacy and safety
- Study Design
- OTHER