Ingenol Mebutate

Actinic Keratosis

Treatment

8 Active Studies for Ingenol Mebutate

What is Ingenol Mebutate

Ingenol mebutate

The Generic name of this drug

Treatment Summary

Picato (Ingenol mebutate) is a gel used to treat actinic keratosis, a skin condition caused by too much sun exposure. It was approved by the FDA in 2012. The active ingredient in Picato, PEP005, is a natural extract from the plant Euphorbia peplus that has been used traditionally to treat skin conditions like warts and cancer. PEP005 also shows promise in treating certain types of leukemia by inducing cell death in myeloid leukemia cells and acute myeloid leukemia cells.

Picato

is the brand name

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Ingenol Mebutate Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Picato

Ingenol mebutate

2012

2

Effectiveness

How Ingenol Mebutate Affects Patients

It is not yet understood how ingenol mebutate works to cause cell death in actinic keratosis.

How Ingenol Mebutate works in the body

The way ingenol mebutate works to treat actinic keratosis is unclear, but it is thought to work by killing cells that cause the condition. It may also reduce the activity of proteins in cells responsible for the condition. This could lead to changes in pathways that reduce the activity of cells that cause actinic keratosis.

When to interrupt dosage

The suggested dosage of Ingenol Mebutate is contingent upon the diagnosed malady. The amount of dosage fluctuates as per the strategy of delivery (e.g. Topical or Gel) specified in the table beneath.

Condition

Dosage

Administration

Actinic Keratosis

0.015 %, , 0.05 %, 0.0005 mg/mg, 0.00015 mg/mg

Topical, Gel - Topical, Gel, , Cutaneous, Gel - Cutaneous

Warnings

Common Ingenol Mebutate Drug Interactions

Drug Name

Risk Level

Description

Ingenol Mebutate Toxicity & Overdose Risk

Common side effects of using this drug include skin reactions near the site of application, headaches, swelling around the eyes, and a sore throat.

image of a doctor in a lab doing drug, clinical research

Ingenol Mebutate Novel Uses: Which Conditions Have a Clinical Trial Featuring Ingenol Mebutate?

Currently, 7 clinical trials are assessing the efficacy of Ingenol Mebutate in treating Actinic Keratosis.

Condition

Clinical Trials

Trial Phases

Actinic Keratosis

8 Actively Recruiting

Not Applicable, Phase 2, Phase 3, Phase 1, Phase 4

Ingenol Mebutate Reviews: What are patients saying about Ingenol Mebutate?

5

Patient Review

2/24/2014

Ingenol Mebutate for Red Patches from Sun Exposure on the Face or Scalp

image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about ingenol mebutate

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is ingenol mebutate used for?

"Picato gel is used to treat a skin condition called actinic keratosis. It contains the active ingredient ingenol mebutate, which comes from a plant. This ingredient works by killing the cells that make up the scaly skin patch."

Answered by AI

Why was Picato taken off the market?

"The MHRA has announced the suspension of the marketing license for ingenol mebutate gel (Picato) due to studies demonstrating an increased risk of skin malignancies from the drug."

Answered by AI

What is ingenol mebutate topical gel?

"Nov 15, 2015Ingenol mebutate gel is used to treat actinic keratosis. Ingenol mebutate is in a class of medications called cytotoxic agents. It works by killing fast-growing cells."

Answered by AI

Is Picato gel still available?

"- LEO Pharma announced it will permanently discontinue the manufacture of Picato (ingenol mebutate) gel. The discontinuation is due to business reasons and is not related to any safety, efficacy or quality concerns. The phase-out is expected to be completed by the end of 2020."

Answered by AI

Clinical Trials for Ingenol Mebutate

Image of Dayton VA Medical Center, Dayton, OH in Dayton, United States.

Topical Imipramine for Actinic Keratosis

18+
All Sexes
Dayton, OH

The purpose of this study is to test the use of topical imipramine in combination with topical photodynamic therapy's (PDT) effect on the effectiveness and pain immunosuppression following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis or "AK") on their skin. These are both FDA-approved medications, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using mice that suggest imipramine might reduce immune system suppression by PDT thus allowing it to work better. Subjects whose provider has decided that they may benefit from PDT to treat their skin due to many AK precancerous lesions will be recruited for this study. Please note that the PDT itself is not experimental, only the imipramine treatment to the skin. There is a separate informed consent for the PDT.

Phase 2
Recruiting

Dayton VA Medical Center, Dayton, OH

Jeffrey Travers, MD

Image of University of California, Davis - Dermatology Department in Sacramento, United States.

Cryotherapy vs 5-Fluorouracil for Actinic Keratosis

18+
All Sexes
Sacramento, CA

The goal of this clinical trial is to compare the effectiveness and safety of two treatments-cryotherapy and 5-Fluorouracil (5-FU)-for actinic keratosis, a common skin condition caused by long-term sun exposure. Cryotherapy is a treatment that uses extreme cold produced by liquid nitrogen to freeze and destroy abnormal cells, and 5-FU is a topical cream applied to the skin to treat lesions by interfering with cell growth. The main questions this trial aims to answer are: * Which treatment, cryotherapy or 5-FU, is more effective in reducing the number of actinic keratosis lesions? * What are the side effects associated with each treatment? * How do these treatments impact patient satisfaction, cosmetic outcomes, and health-related quality of life? Participants will: * Undergo a baseline assessment where their demographics information such as age, sex, race, smoking status, and medical history are recorded, along with the number and severity of actinic keratosis lesions. * Receive both cryotherapy and 5-FU, with each treatment applied to different areas of their body. The area of the body to receive each treatment is decided by a random process (like flipping a coin). * Complete weekly surveys to monitor for side effects during and after the treatment period. * Return to the clinic for follow-up assessments at 3 months and 12 months.

Phase 4
Waitlist Available

University of California, Davis - Dermatology Department

Daniel Eisen, MD

Image of University of Arizona Cancer Center - Prevention Research Clinic in Tucson, United States.

Calcipotriene + 5-Fluorouracil for Actinic Keratosis

18+
All Sexes
Tucson, AZ

This phase IIA study evaluates the effects of calcipotriene plus 5- fluorouracil immunotherapy for skin cancer prevention in organ transplant recipients. Solid organ transplant recipients are at high risk of developing skin cancer. Actinic keratosis (AK), is a premalignant skin lesion that can progress to squamous cell skin cancer. In this study, solid organ transplant recipients with multiple AKs are treated with topical calcipotriene and 5-FU to evaluate how effective this therapy is against AKs and if this could lower their risk of skin cancer. Topical calcipotriene is a form of vitamin D and is used to treat psoriasis. Prior research reported immunomodulatory effects in the skin induced by topical calcipotriene. Topical 5- fluorouracil is a chemotherapy agent and is one of the therapy options for multiple AKs in specific clinical scenarios. Prior research indicates that topical calcipotriene used together with topical 5-FU was more effective in treating multiple AKs than 5-FU alone in individuals with healthy immune system. This study is investigating now if similar beneficial effects can be seen in immunosuppressed individuals who are solid organ transplant recipients.

Phase 2
Waitlist Available

University of Arizona Cancer Center - Prevention Research Clinic (+5 Sites)

Shadmehr Demehri

Have you considered Ingenol Mebutate clinical trials?

We made a collection of clinical trials featuring Ingenol Mebutate, we think they might fit your search criteria.
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Image of Northwestern University Department of Dermatology in Chicago, United States.

Photodynamic Therapy vs Chemical Peels for Actinic Keratosis

18+
All Sexes
Chicago, IL

The purpose of this study is to to compare photodynamic therapy (PDT) versus the combination of Jessner's solution and 35% trichloroacetic acid (TCA) chemical peels for the treatment of actinic keratoses on upper extremities. This is a randomized clinical trial. Approximately 60 participants with actinic keratoses on both upper arms will be randomized to have one arm receive photodynamic therapy, while the contralateral arm receives Jessner's solution followed immediately by 35% TCA. AKs will be counted before treatment and 2-8 weeks after treatment. This study is a pilot study designed to determine the feasibility of this procedure. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.

Phase 2
Waitlist Available

Northwestern University Department of Dermatology

Murad Alam, MD

Image of Dayton VA Medical Center in Dayton, United States.

Fractionated Laser Resurfacing for Actinic Keratosis and Skin Cancer Prevention

18+
All Sexes
Dayton, OH

This study is following up on previous studies that have demonstrated that geriatric subjects respond different to ultraviolet B (UVB) light than young subjects. The treatment of geriatric skin with dermal rejuvenation therapies (dermabrasion, fractionated laser resurfacing) restores the appropriate UVB response. Ongoing studies have tested the ability of fractionated laser resurfacing (FLR) to assess how long this wounding effect lasts-and have found that this appears to be a durable response which lasts for at least two years. The findings that FLR protects geriatric skin at two years is the impetus for this study. This study is an interventional study to assess if FLR treatment of one forearm of geriatric subjects with multiple actinic keratosis will result in the short-term removal of actinic keratosis, and the long-term decrease in levels of future actinic keratosis and other non-melanoma skin cancers in comparison to the untreated arm. Study length and visit: The first part of the study is completed in 1 day then there are follow up visits at 90 days and every 6 months for 5 years.

Recruiting
Has No Placebo

Dayton VA Medical Center

Jeffrey B Travers, MD, PhD