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ORLANDO -- Patients with actinic keratosis (AK) had almost an 80% reduction in lesion count after three applications of an ingenol derivative formulated for broad-area treatment, according to a study reported here.

After 8 weeks, the number of facial and chest lesions had decreased by 79% and the number of scalp lesions by 76% in response to treatment with ingenol disoxate. About 40% of patients had complete clearance of lesions at 8 weeks. Fourteen percent of patients (n=9) had dose-limiting events (DLEs), as defined by local skin reaction (LSR).

The reduction in lesion count was associated with high rates of patient satisfaction with the treatment, , of Long Island Skin Cancer and Dermatologic Surgery in New York, reported at the meeting.

"This is essentially the next-generation treatment with an ingenol derivative," said Siegel. "You can treat a large area. It's a short-term treatment. The local skin response-side effect profile is essentially the same as with ingenol mebutate (Picato): highly tolerable."

Several topical therapies have FDA approval for treatment of AK. Most of the products require frequent application and ongoing use for periods ranging from weeks to months.

Authors of a cited two advantages of ingenol mebutate versus other available products: quick resolution of local skin reaction and short duration of treatment.

However, ingenol mebutate was designed for application to relatively small skin areas, up to 25 cm². In contrast, ingenol disoxate was developed for "field treatment," application to areas ranging up to 250 cm², said Siegel.

In previous phase II clinical trials, ingenol disoxate demonstrated as , applied on two consecutive days to large areas of the face, chest, and scalp. The trials also showed high levels of patient satisfaction with the treatment.

Siegel presented data from a phase II trial of ingenol disoxate for field treatment of AKs. The primary endpoint was the incidence of DLEs up to day 8. Secondary endpoints were change in lesion count and clearance rate by AKCLEAR criteria. The trial involved adults with at least five and as many as 20 typical, visible, AK lesions, either on the full face or within a 250 cm² contiguous area of the skin.

Investigators assigned 189 patients to three groups (63 per group), defined by the treated area: face/chest, scalp, and trunk/extremities. Study participants applied ingenol disoxate once daily for three consecutive days to the face, chest, scalp, or trunk/extremities. Follow-up continued to 8 weeks. Siegel reported data for the face/chest and scalp groups.

The study population consisted primarily of older (65 to 66) men (102 of 126). Most of the patients (107) had II-III, a median AK duration of 7 to 10 years, and median AK count of 10 to 11.

Siegel reported that all nine DLEs occurred in the face/chest group. Investigators used six criteria to define LSR: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration (each rated on a scale of 0 to 4). The composite score reached a peak of 10.5 and 10.4 for face/chest and scalp, respectively, on day 4 and then declined rapidly thereafter.

A second presentation at the AAD meeting focused on cosmetic outcomes and patient satisfaction. Results at 8 weeks showed that 66% of patients in the face/chest group and 69% of those in the scalp group had improvement in photodamage, including 53% and 40%, respectively, who had marked or moderate improvement.

Almost all of the patients rated the cosmetic outcome as improved at 8 weeks, including 95% of patients in the face/chest group and 97% in the scalp group. Additionally, 68% of the face/chest group and 79% of the scalp group rated their overall appearance of the treated area as "much improved."

The treatment satisfaction questionnaire comprised four domains, and patient ratings ranged from 74% to 91% for effectiveness, side effects, convenience, and global satisfaction.

Noting the 25 cm² limitation on the application area for ingenol mebutate, Siegel said the principal advantage of ingenol disoxate is the ability use it for field treatment.

"There is no more 25, 25, 25. It's whole face, whole scalp, broad chest," he said. "You can treat it all in one fell swoop. You can't say 'once and done,' because when it comes to market it will probably be indicated for treatment of a broad area for 3 days. Anyone can do this for 3 days. Even me."