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

@article{Siller2009PEP005M,
  title={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},
  author={Greg Siller and Kurt A. Gebauer and Peter Welburn and Janelle Katsamas and Steven M. Ogbourne},
  journal={Australasian Journal of Dermatology},
  year={2009},
  volume={50}
}
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. This randomized, double‐blind, vehicle‐controlled, phase IIa study investigated the safety (and secondarily the efficacy) of two applications of ingenol mebutate gel in 58 patients with biopsy‐confirmed actinic keratosis. Five preselected lesions were treated with ingenol mebutate gel… 
Ingenol Mebutate Gel 0.015% and 0.05%
TLDR
Topical ingenol mebutate gel was generally well tolerated in the treatment of patients with actinic keratoses on the face or scalp and on the trunk or extremities and application-site conditions were the most commonly occurring adverse events.
Safety and tolerability of ingenol mebutate in the treatment of actinic keratosis
  • B. Berman
  • Medicine
    Expert opinion on drug safety
  • 2015
TLDR
Ingenol mebutate enhances the armamentarium available to the dermatologist for the treatment of AK and has a dosing period of 2 – 3 days, which is short compared with other field therapies, and there is no evidence of systemic absorption.
Ingenol mebutate: from common weed to cancer cure.
TLDR
The topical formulation of ingenol mebutate, which is a protein kinase C inhibitor derived from the sap of the plant Euphorbia peplus, is the newest addition to the existing arsenal of field-directed treatments.
Ingenol mebutate (ingenol 3-angelate, PEP005): focus on its uses in the treatment of nonmelanoma skin cancer
TLDR
Research studies have revealed that ingenol mebutate has both a direct cytotoxic effect and a local moderate acute inflammatory response in mediating its anticancer effects, and in addition to its high efficacy in the treatment of NMSC, clinical studies have reported ingenolmebutate to have minor application site side effects that resolved shortly after stopping treatment.
Ingenol Mebutate for the Treatment of Actinic Keratosis
TLDR
Topical ingenol mebutate gel, derived from the sap of the plant Euphorbia peplus, has been recently FDA-approved as a field therapy for treatment of AKs and its efficacy, safety, and tolerability have been demonstrated.
Ingenol Mebutate: A Promising Treatment for Actinic Keratoses and Nonmelanoma Skin Cancers
TLDR
Ingenol mebutate treatment resulted in short- and long-term efficacy similar to other topical treatments for actinic keratoses in a shorter period of 2 or 3 days, and this short therapy would reduce the duration of adverse events.
Ingenol Mebutate: An Emerging Therapy in the Treatment of Actinic Keratoses
TLDR
A literature review of the data from phase II and III clinical trials reveals that ingenol mebutate gel is an efficacious and safe therapy for actinic keratoses when used on areas of skin up to 25 cm2.
A randomized, double-blind, placebo-controlled clinical trial evaluating Dermytol® cream for the treatment of actinic keratoses
TLDR
The results of this study and previous in vitro studies suggest a potential role for CPA in the treatment of AK lesions and the prevention of SCC development.
Ingenol mebutate: A novel topical drug for actinic keratosis
TLDR
Ingenol mebutate is a novel topical drug from the latex sap of a plant-Euphorbia peplus that acts by chemoablative and immunostimulatory properties that leads to FDA approval of this chemotherapeutic agent for field therapy of AK in 2012.
Ingenol mebutate for the treatment of actinic keratosis: effectiveness and safety in 246 patients treated in real-life clinical practice
TLDR
It is concluded that gender (female) and age (under 70 years-old) show a tendency to have better efficacy outcomes but without clinical relevance, and topical IMG was generally well tolerated and had positive cosmetic results after 60 d.
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TLDR
A novel route by which the anti-tumor agent PEP005 regulates the recruitment of cytotoxic leukocytes by directly activating EC in a PKC-δ dependent manner is described.
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TLDR
PEP005 emerges as a new topical anti-skin cancer agent that has a novel mode of action involving plasma membrane and mitochondrial disruption and primary necrosis, ultimately resulting in an excellent cosmetic outcome.
Neutrophils Are a Key Component of the Antitumor Efficacy of Topical Chemotherapy with Ingenol-3-Angelate1
TLDR
Evidence that neutrophils are required to prevent relapse of skin tumors following topical treatment with a new anticancer agent, ingenol-3-angelate (PEP005), and a central role for neutrophil-mediated ADCC in preventing relapse are suggested, illustrating that neutophils can be induced to mediate important anticancer activity with specific chemotherapeutic agents.
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TLDR
Aloe vera was the most popular remedy and paw paw and creams such as lanolin were also popular despite their generally perceived lack of efficacy, and Euphorbia peplus was unanimously considered an effective treatment.
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TLDR
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