Picato® gel (Ingenol Mebutate) is a topical medication that is used to treat sunspots (also called "actinic keratoses" or "solar keratoses"). It differs from other topical creams such as Aldara® (imiquimod) and Efudix® (fluorouracil) because it only requires daily application for two or three days to achieve its effect, rather than for 3-8 weeks.
About Picato®
Picato® is available only with a doctor's prescription and comes in two different strengths (0.05% and 0.015%), the choice of which is made by your doctor based on the area of the body that is being treated. You can expect a reduction in sunspots of around 80-85% in the areas treated after the course of treatment. Treatment on the face or scalp is generally for two days, whereas treatment on the limbs or trunk is for three days. The medication costs around $140 to purchase at a pharmacy or chemist and is not listed on the Pharmaceutical Benefits Scheme.
Picato® is a medication that is developed and produced in Australia. In 1997 Australian scientists isolated a group of compounds from the Euphorbia peplus plant. The active ingredient in Picato® is ingenol mebutate, which is produced in Australia. Queensland and New South Wales are the only places in the world where the plant is grown for commercial use.
PICATO Rx
Active Ingredient(s):
Ingenol mebutate 0.015%, 0.05%; topical gel.

Company
LEO Pharma Inc.

Indication(s):
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 3 consecutive days, followed by an 8 week follow-up period. The studies enrolled subjects with 4–8 clinically typical, visible, discrete AK lesions within a 25cm2 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 2 consecutive days, followed by an 8 week follow-up period. The studies enrolled subjects with 4–8 clinically typical, visible, discrete AK lesions within a 25cm2 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.

Legal Classification:
Rx

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 3 consecutive days. Trunk and extremities: apply 0.05% gel to the affected area once daily for 2 consecutive days. Limit application to one contiguous skin area of approximately 25cm2 using one unit dose tube. Allow treated area to dry for 15 minutes after application. Wash hands immediately after application; avoid inadvertent transfer of drug to other areas (eg, eyes). Avoid washing and touching treated area for 6 hours after application; following this time, may wash with mild soap.

Children:
<18yrs: not established.

Warnings/Precautions:
Eye disorders (eg, 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 (Cat. C). Nursing mothers.

Adverse Reaction(s)
Local skin reactions (eg, 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
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5accc7a5-8209-4680-b0ae-2a6963500419