New option 
for actinic 
keratosis

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New option 
for actinic 
keratosis
New option 
for actinic 
keratosis

Product: Picato


Company: LEO Pharma 


Active ingredient: Ingenol mebutate 0.015%, 0.05%; topical gel


Indication: Topical treatment of actinic keratosis (AK)


Pharmacology: The mechanism of action by which ingenol mebutate induces cell death in treating actinic keratosis lesions is unknown. 


Clinical trials: In two double-blind, vehicle-controlled, clinical trials (Study 1 and Study 2), 547 adult subjects with AK on the face or scalp were randomized to treatment with either Picato gel, 0.015% or vehicle gel for three consecutive days, followed by an eight-week follow-up period. The studies enrolled subjects with four to eight clinically typical, visible, discrete AK lesions within a 25-cm2 contiguous treatment area. Hypertrophic and hyperkeratotic lesions were excluded. On each dosing day, gel was applied to the entire treatment area.

Efficacy was assessed at Day 57. Complete clearance rate was defined as the proportion of subjects with no (zero) clinically visible AK lesions in the treatment area. Partial clearance rate was defined as the proportion of subjects with ≥75% reduction in the number of AK lesions at baseline in the selected treatment area.

In Study 1, the complete clearance rate for Picato was 37% and vehicle was 2%; partial clearance rate for Picato was 60% and vehicle was 7%. In Study 2, the complete clearance rate for Picato was 47% and vehicle was 5%; partial clearance rate for Picato was 68% and vehicle was 8%. 


In two other double-blind, vehicle-controlled clinical trials (Study 3 and Study 4), 458 adults with AK on the trunk or extremities were randomized to treatment with either Picato gel, 0.05% or vehicle gel for two consecutive days, followed by an eight-week follow-up period. The studies enrolled subjects with four to eight clinically typical, visible, discrete AK lesions within a 25-cm2 contiguous treatment area. Hypertrophic and hyperkeratotic lesions were excluded. On each dosing day, gel was applied to the entire treatment area. 


In Study 3, at Day 57, the complete clearance rate for Picato was 28% and vehicle was 5%; partial clearance rate for Picato was 44% and vehicle was 7%. 


In Study 4, the complete clearance rate for Picato was 42% and vehicle was 5%; partial clearance rate for Picato was 55% and vehicle was 7%. 


Subjects who achieved complete clearance at Day 57 in Study 1, 2, and 4 entered a 12-month follow-up period.


Adults: For topical use only; not for oral, ophthalmic, or intravaginal use. Face and scalp: apply 0.015% gel to the affected area once daily for three consecutive days. Trunk and extremities: apply 0.05% gel to the affected area once daily for two consecutive days. Limit to one contiguous skin area of about 25 cm2 using one unit dose tube. Allow treated area to dry for 15 minutes after application. Wash hands immediately after application; avoid inadvertent transfer to other areas. Avoid washing and touching treated area for six hours after application; following this time, may wash with mild soap. 


Children: <18 years: not established.


Warnings/Precautions: Eye disorders (e.g., severe eye pain, eyelid edema, eyelid ptosis, periorbital edema) may occur after exposure. Avoid contact with the periocular area. Administration not recommended until skin is healed from previous drug or surgical treatment. Severe skin reactions. Pregnancy (Category C). Nursing mothers.


Adverse reactions: Local skin reactions (e.g., erythema, crusting, swelling, vesiculation/pustulation, erosion/ulceration), application site pain/pruritus/irritation/infection, periorbital edema, nasopharyngitis, headache. 


How supplied: Single-use tubes 0.015%—3 0.05%—2


For more information, 
call 877.494.4536 or visit www.Leo-pharma.us.

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