New Actinic Keratosis Treatment Approved by the FDA

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Picato gel (ingenol mebutate) is now approved by the U.S. Food and Drug Administration for the treatment of actinic keratosis (AK). AK is a precancerous skin condition caused by excess sun exposure.

The gel comes in two strengths -- .015% is used once a day on the face and scalp for three consecutive days and .05% is used on the trunk and extremities for two consecutive days.

What makes Picato gel different from other topical AK medication is that it is effective after only two or three days of use.

Actinic keratosis is a potentially dangerous skin lesion as it can lead to squamous cell skin cancer. “According to the Academy of Dermatology (AAD) one in five Americans will develop skin cancer in their lifetime and studies show that 65% of squamous cell cancer began as untreated actinic keratosis.” (1)

Leo pharma, the manufacturer of Picato gel, is a Denmark based company that specializes in dermatology and critical care products. In order to achieve FDA approval, Picato gel was tested in four phase III clinical studies of over 1000 patients with actinic keratosis, and there were 18 clinical trials performed overall.

In the early phase I trials, over 60 percent of the patients had over 75 percent of their AK lesions on their face and scalp improved while the control group only had 8 percent improvement.

The patients in the trunk extremities group also had a 75 percent improvement in approximately 50 percent of the test group. Some patients in the phase III clinical trial group had complete clearance of their AK.

The most common side effects for Picato gel included: erythema (redness), flaking/scaling, crusting and swelling.

Currently, actinic keratosis is treated topically using: 5-Fluorouracil, Imiquimod or topical diclofenac sodium 3 percent gel. (2)

5-Fluorouracil is commonly used as a 5 percent cream applied twice a day for a month. During treatment, the lesions can become severely reddened with ulcerations and crusting. Two weeks after finishing treatment, the complexion smoothes and the AK lesions improve.

Imiquimod is applied two-three times a week for up to four months, although generally one month is sufficient. Some people have more of an inflammatory response than others do. Creams with lower concentrations of the drug can be used to encourage more compliance to finish the treatment.

Topical diclofenac sodium 3 percent gel is a nonsteroidal anti-inflammatory drug also approved by the FDA for the treatment of actinic keratosis. It is applied twice a day for three months. It produces little to no inflammation so patients are more likely to stick with the three-month regimen.

Dr. Mark Lebwohl, one of the study investigators from the Department of Dermatology at Mount Sinai Medical Center in New York City stressed how important it is to detect and treat AK lesions early since there is no way to know which ones will go on and develop into skin cancer.

Lebwohl expressed that what made Picato gel an exciting new medication is that only a two or three day course of treatment is needed compared to the other therapies which require longer times.

Sources:

1. FDA Approves Picato® (ingenol mebutate) Gel, the First and Only Topical Actinic Keratosis (AK) Therapy With 2 or 3 Consecutive Days of Once-Daily Dosing. NJ.com PR Newswire. Retrieved Jan. 26, 2012.
http://www.nj.com/business/prnewswire/index.ssf?/nj/story/?catSetID=7002...

2. Actinic Keratosis Author: James M Spencer, MD; Medscape Reference. Retrieved Jan. 26, 2012.
http://emedicine.medscape.com/article/1099775-overview#showall

3. LEO Pharma products. LEO Pharma Inc. Retrieved Jan. 26, 2012. http://www.leo-pharma.us/home/products/LEO-pharma-products.aspx

Michele is an R.N. freelance writer with a special interest in woman’s healthcare and quality of care issues. Other articles by Michele are at www.helium.com/users/487540/show_articles

Edited by Jody Smith

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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.