Picato

Actinic Keratosis
Treatment
11 Active Studies for Picato

What is Picato

Ingenol mebutateThe Generic name of this drug
Treatment SummaryIngenol mebutate, sold under the brand name Picato®, is a topical gel used to treat actinic keratosis. It is derived from a plant called Euphorbia peplus, whose sap has been used for centuries to treat skin conditions such as warts and cancer. In addition, it has been found to have powerful anti-leukemia effects, capable of killing myeloid leukemia cells and primary AML cells at very low concentrations. Ingenol mebutate was approved by the FDA in 2012.
Picatois the brand name
image of different drug pills on a surface
Picato Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Picato
Ingenol mebutate
2012
2

Effectiveness

How Picato Affects PatientsIt is not known how ingenol mebutate works to cause cell death in actinic keratosis.
How Picato works in the bodyThe way ingenol mebutate works against actinic keratosis is not entirely clear. It likely involves killing the cells first, then triggering an immune response to finish off any remaining cells. Studies have also shown that ingenol mebutate activates and moves certain proteins into the nucleus and membranes of cells, and decreases the activity of some other proteins. This leads to the activation of certain pathways in the cell, which helps stop the disease from progressing.

When to interrupt dosage

The amount of Picato is contingent upon the diagnosed affliction. The degree of dosage fluctuates as per the technique of delivery (e.g. Topical or Gel) featured in the table below.
Condition
Dosage
Administration
Actinic Keratosis
0.015 %, , 0.05 %, 0.0005 mg/mg, 0.00015 mg/mg
Topical, Gel - Topical, Gel, , Gel - Cutaneous, Cutaneous

Warnings

Common Picato Drug Interactions
Drug Name
Risk Level
Description
Picato Toxicity & Overdose RiskCommon side effects of using this drug include skin irritation or redness at the application site, headaches, puffiness or swelling around the eyes, and inflammation of the nose and throat.
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Picato Novel Uses: Which Conditions Have a Clinical Trial Featuring Picato?

An ongoing examination is assessing the potential of Picato to address Actinic Keratosis.
Condition
Clinical Trials
Trial Phases
Actinic Keratosis
10 Actively Recruiting
Not Applicable, Phase 2, Phase 3, Phase 1, Phase 4

Picato Reviews: What are patients saying about Picato?

5Patient Review
11/26/2019
Picato for Red Patches from Sun Exposure on the Face or Scalp
Picato was great for me, no pain at all. Only thing was that my skin felt a little tight after using it, but the crusty bits fell off soon enough. I'm just curious if anyone knows if you can put makeup or face powder on new pink skin?
4.7Patient Review
4/20/2017
Picato for Red Patches from Sun Exposure on the Face or Scalp
I used this three times and my pre-cancer lower lip has improved. The side effects were minor compared to another medication
4.3Patient Review
10/5/2017
Picato for Red Patches from Sun Exposure on the Face or Scalp
This medication is effective, though results may vary from person to person. I've used it three times with different responses each time. This last round of treatment has been the most successful in terms of reducing redness and swelling.
4.3Patient Review
5/14/2019
Picato for Red Patches from Sun Exposure on the Face or Scalp
I only had to use this gel three times over the course of three days, which was awesome. The tradeoff was that it caused a little redness and irritation, but it did get rid of the scaly patches, so I'm happy.
2.3Patient Review
3/22/2017
Picato for Red Patches from Sun Exposure on the Face or Scalp
If you have sensitive skin, I would recommend avoiding this treatment. My face became incredibly swollen and painful after just a small amount was applied. It's very expensive too, so it wasn't worth it for me.
2.3Patient Review
10/19/2017
Picato for Red Patches from Sun Exposure on the Face or Scalp
I used this on an AK above my lip. I tried not to let it touch my lips, as the directions said not to use it on them. I used it at bedtime, which you are not supposed to do, I learned later. During the night, it was stinging a lot, and I rinsed it off after six hours. By morning, my lip looked swollen and red. After reading other reviews, I discontinued use rather than risk worsening effects.
1.7Patient Review
3/31/2020
Picato for Red Patches from Sun Exposure on the Face or Scalp
Efudex is much more effective than this treatment. Save your time and money.
1Patient Review
3/8/2019
Picato for Red Patches from Sun Exposure on the Face or Scalp
I'm not going to use this gel based on the reviews I've read. It seems like a really painful procedure with no guarantee of success, and I don't understand why a doctor would recommend it over other options.
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Patient Q&A Section about picato

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

What is Picato cream used for?

"Picato is a medication that comes in the form of a gel. It is applied to areas of the skin affected by actinic keratosis, which is a condition caused by too much exposure to sunlight. If left untreated, actinic keratosis can turn into skin cancer."

Answered by AI

Is Picato better than efudex?

"Picato, a cream developed in Australia, is used in a similar way to efudix, but the treatment times are shorter (once a day for either 2 or 3 days, depending on where it is used). The reactions to it tend to be more severe than to efudix, including blistering."

Answered by AI

Why was Picato discontinued?

"- LEO Pharma announces the discontinuation of Picato gel due to business reasons. This decision is not based on any safety, efficacy or quality concerns. The phase-out process is expected to be completed by the end of 2020."

Answered by AI

What does Picato do to the skin?

"Picato gel is a topical medication prescribed to treat a condition called actinic keratosis. The active ingredient in Picato gel is derived from a plant, and it works by killing the cells that comprise the scaly skin patch."

Answered by AI

Clinical Trials for Picato

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 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, OHJeffrey 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 DepartmentDaniel Eisen, MD
Have you considered Picato clinical trials? We made a collection of clinical trials featuring Picato, we think they might fit your search criteria.Go to Trials
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
Image of Wright State Physicians in Fairborn, United States.

Imipramine + Photodynamic Therapy for Actinic Keratosis

18+
All Sexes
Fairborn, OH
The purpose of this study is testing the use of topical Imipramine in combination with topical photodynamic therapy's (PDT) effect on pain following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis-AKs) on their skin. These are both FDA-approved treatments, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using animals that suggest that imipramine might make the PDT less painful and might help it work better. In order to participate, the subject and their dermatologist have decided that they would benefit from PDT to treat their skin due to many AK precancerous lesions. Please note that neither PDT nor imipramine are experimental treatments, but treating their skin with imipramine before PDT is a new approach.
Phase 1
Recruiting
Wright State PhysiciansCraig Rohan, MD
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 DermatologyMurad Alam, MD
Have you considered Picato clinical trials? We made a collection of clinical trials featuring Picato, we think they might fit your search criteria.Go to Trials
Image of Northwestern University Feinberg School of Medicine, Department of Dermatology in Chicago, United States.

Photodynamic Therapy for Actinic Keratosis

18+
All Sexes
Chicago, IL
This is a randomized clinical trial evaluating blue light 5-aminolevulinic acid (ALA) photodynamic therapy with different incubation times for the treatment of actinic keratosis. Subjects who are interested in participating, currently living in the Chicago metropolitan area, and meet inclusion and exclusion criteria will be enrolled in the study. Subjects will be randomized to either 1) zero time ALA incubation or 2) 1 hour ALA incubation. Demographic and health data will be collected prior to treatment initiation. Three visits will be conducted: screening, treatment, and follow up visit at 8 weeks. This study is a pilot study designed to determine feasibility of this procedure.
Waitlist Available
Has No Placebo
Northwestern University Feinberg School of Medicine, Department of DermatologyMurad Alam, MD
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