Why carry out this study?

Several therapeutic options are currently available, but not all are indicated on hyperkeratotic lesions.

Current guidelines recommend treating Actinic keratosis (AK), even if spontaneous lesion regression is possible to minimize the risk of progression to squamous cell carcinoma (SCC).

What was learned from the study?

Few clinical studies have addressed hyperkeratotic AKs. 2,4,6-Octatrienoic acid is reported to be effective on photodamaged skin and mild-to-moderate AKs.

In the present randomized double-blind parallel-group study, subjects with grade III AK were treated once daily for 3 months with the medical device under study showing a significant reduction in the number of AK lesions compared with placebo.

The total local skin reaction (LSR) scores were statistically reduced in subjects treated with the medical device after 3 months of treatment and follow-up (further 3 months). Complete clearance of lesions was observed during the first 3 months after the treatment period (i.e., the follow-up period) in 56.7% of the subjects treated with the medical device, and complete clearance was achieved in 27.5% of subjects during the first 3 months after the treatment period (i.e., the follow-up period).