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Ingenol mebutate gel cleared actinic keratoses for up to 1 year
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Ingenol mebutate gel applied to patients’ affected skin for 2 or 3 consecutive days resulted in sustained clearance of actinic keratoses and long-term lesion reduction up to 1 year later, according to recent study results.
In a follow-up study, researchers evaluated patients who had actinic keratoses on the face or scalp and were assigned 0.015% ingenol mebutate gel daily for 3 consecutive days or patients who had actinic keratoses on the trunk or extremities and were assigned 0.05% ingenol mebutate gel daily for 2 consecutive days. At day 57 of the original trial, study participants had achieved complete clearance of the predetermined areas.
One hundred patients with full clearance of facial or scalp lesions and 71 patients with complete clearance of trunk or extremities fulfilled the 12-month, follow-up trial. Mean age of the patients was 63.2 years; 70.7% were men.
Sustained clearance rates at 1 year were 46.1% for patients treated on the face or scalp and 44% for patients treated on the trunk or extremities. Actinic keratoses lesions of the face or scalp also were reduced by 87.2% compared with baseline, and trunk or extremity lesion reductions were 86.8%. Median times to recurrence were estimated at 365 days for face or scalp and 274 days for trunk or extremities.
Three patients experienced mild sunburn, moderate hematoma or a mild rash in the target area; investigators said none of the events was therapy-related, and all resolved.
“The absence of related safety issues … confirms that ingenol mebutate was well tolerated,” the researchers concluded. “Ingenol mebutate gel … was effective when treating head or body actinic keratoses, producing clinically relevant sustained clearance and long-term reduction in the number of lesions in the selected field by virtue of its dual mechanism of action that combines rapid direct cell death with a neutrophil-mediated immune response.”
Disclosure: See the study for a full list of relevant disclosures.
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