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Picato (Ingenol Mebutate) - Summary

 
 



PICATO SUMMARY

Picato® (ingenol mebutate) gel, 0.015% or 0.05% is a clear colorless gel for topical administration, which contains the active substance ingenol mebutate, an inducer of cell death.

Picato® gel is indicated for the topical treatment of actinic keratosis.
See all Picato indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Picato (Ingenol Mebutate)

Ingenol mebutate gel for actinic keratosis. [2012]
mebutate gel (0.015% for face and scalp and 0.05% for trunk and extremities)... CONCLUSIONS: Ingenol mebutate gel applied topically for 2 to 3 days is effective

PEP005 (ingenol mebutate) gel, a novel agent for the treatment of actinic keratosis: results of a randomized, double-blind, vehicle-controlled, multicentre, phase IIa study. [2009]
The sap of the plant Euphorbia peplus is a traditional remedy for skin conditions, including actinic keratosis. The active constituent of the sap is ingenol mebutate (ingenol-3-angelate), formerly known as PEP005...

Ingenol mebutate gel for actinic keratosis: the link between quality of life, treatment satisfaction, and clinical outcomes. [2015]
lesion clearance... CONCLUSION: Ingenol mebutate significantly improved patients' QoL and treatment

PEP005 (ingenol mebutate) gel for the topical treatment of superficial basal cell carcinoma: results of a randomized phase IIa trial. [2010]
end-point... CONCLUSIONS: Two applications of ingenol mebutate gel, 0.05%, are safe and have

Randomized, double-blind, double-dummy, vehicle-controlled study of ingenol mebutate gel 0.025% and 0.05% for actinic keratosis. [2009]
gel at 3 dosing regimens for the treatment of actinic keratosis... CONCLUSIONS: Short-course, field-directed therapy with ingenol mebutate gel for

more studies >>

Clinical Trials Related to Picato (Ingenol Mebutate)

Ingenol Mebutate (Picato�) With Methyl Aminolevulinate Photodynamic Therapy for the Treatment of Actinic Keratosis [Active, not recruiting]
The objective of this study is to determine the efficacy, safety, and patient satisfaction of pretreatment with Picato gel 4 days prior to methyl aminolevulinate photodynamic therapy (MAL PDT). Patients diagnosed with actinic keratosis who are eligible to receive topical treatment with ingenol mebutate (Picato) and photodynamic therapy will act both as the test group and the control group. Each patient will have four distinct treatment areas of 25cm2 on the scalp, and/or scalp and face. Three of the treatment areas will receive Picato 0. 015% gel, MAL PDT, or Picato 0. 05% and MAL PDT combined. One area will serve as a control and will receive none of the treatments.

PMS to Evaluate the Safety and Efficacy of Picato� Gel [Recruiting]
This study is a mandatory post launch observational study in South Korea of 3. 000 patients receiving treatment for the first time with a new medicinal product, ingenol mebutate gel (Picato), approved for topical treatment of actinic keratosis. Each patient is observed for 8 weeks after treatment completion.

Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate in a Period of 8 Weeks [Recruiting]
Assessment of treatment success and quality of life in patients with actinic keratoses under therapy with Ingenol Mebutate (Picato) in a period of 8 weeks.

Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm [Completed]
The purpose of this study is to determine if the new vehicle formulations containing ingenol mebutate are as safe and effective as Picato gel 0. 05% (it's current vehicle formulation) when applied to AK lesions on the forearm for two consecutive days.

Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp [Completed]
Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet radiation exposure. While most authorities consider AK as a pre-malignant lesion, some consider it as an incipient squamous cell carcinoma (SCC). Among the current therapies for the treatment of AK are excisional surgery, cryosurgery, electrodesiccation and curettage, topical chemotherapy and light therapies. Cryosurgery is considered the gold standard for therapy, however as with other lesion-directed therapies, cryosurgery does not treat subclinical lesions in the surrounding skin. Ingenol mebutate is the active compound in the sap from Euphorbia peplus L. (E. peplus). Topical ingenol mebutate treatment has been approved for the treatment of AKs. The goal of AK therapy for all physicians is to provide an effective, tissue-sparing treatment with good cosmetic results. Ingenol mebutate gel 0. 015% has shown to not only have a high clearance rate but also a transient localized inflammatory skin response that resolves quickly without sequelae. However, one common fear about ingenol mebutate is that it's mechanism of action is purely destructive to both AKs and healthy skin, and that retreatment would produce an equally, if not more, caustic result on the skin such as severe erosion, scaling, and erythema. It is our hope to debunk this misconception and demonstrate that reapplication of a second cycle of ingenol mebutate would result in lower LSR scores compared to the LSR in the first cycle of application. We plan to treat 20 subjects. Each qualifying subject will have at least 4-8 non-hypertrophic AKs in a 25 cm2 treatment area on the face or scalp. All subjects will be treated with two cycles of ingenol mebutate 0. 015%. The first cycle will be started on Day 1, and the second cycle will be started on Day 29 (four weeks apart). Subjects will utilize the once daily for three days regimen for both cycles.

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Reports of Suspected Picato (Ingenol Mebutate) Side Effects

Application Site Vesicles (5)Erythema (3)Myalgia (3)Skin Ulcer (3)Application Site Erythema (3)Staphylococcal Infection (3)Application Site Swelling (2)Pain (2)Pyrexia (2)Dermatitis Contact (2)more >>


Page last updated: 2015-08-10

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