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PEP005: A New Cream for Actinic Keratosis

By January 4, 2009

A potential new treatment for actinic keratosis (AK; also called solar keratosis) has just completed a critical phase III clinical trial. AK is a pre-cancerous skin condition that appears as a dry, scaly lesion caused by prolonged and repeated sun exposure. The American Academy of Dermatology reports that 40% of cases of squamous cell carcinoma begin as AKs. If the results of the trial are positive, it could be a serious competitor to imiquimod (Aldara) for the treatment of the most common forms of skin cancer.

The new treatment, called PEP005, is a topical gel containing a molecule called ingenol 3-angelate. It is derived from the milky sap of a common garden weed called the petty spurge or radium weed (scientifically, Euphorbia peplus), which has long been used as a traditional folk medicine in many countries for the treatment of skin conditions. It activates a molecule in the body called protein kinase C, which in turn helps control various cellular functions. The previous phase II trials showed promising results: after applying the gel for only two days, 71-75% of the lesions disappeared after two months. Side effects were no more serious than localized redness and peeling. PEP005 is also being studied for the treatment of basal cell carcinoma, bladder cancer, and even leukemia.

This is the proper way for natural products to enter the market: use "traditional" knowledge and "home remedies" for initial ideas, then isolate the specific chemical that is responsible for the effect, then thoroughly test it using double-blind clinical trials. You might be surprised to learn that the herbs, supplements and homeopathic remedies on your store shelves don't typically go through this process -- and for that reason, are usually no more effective than a placebo.

Source:

"Peplin Completes Enrollment for its First Phase III AK Clinical Trial." Peplin. 2 January 2009.

Comments
May 20, 2009 at 2:14 am
(1) P Ferguson says:

I have been waiting for the pep gel ever since I first read about it several years ago … pity it still isn’t availab.e

Being afair haired, blue eyed anglo saxon, I have been subject to keratosis since I was in my 20′s, and usually have them burnt off annually with carbondioxide snow.
On 2 or 3 occasions I have used Equinox, which is a painful process taking up to 3 weeks and makes one’s face look diseased!
My time is nearly up, but it would be nice to know I don’t have to use equinox again.
Incidently, as kids we used to use radium weed sap to burn off warts – it worked.

May 20, 2009 at 2:25 am
(2) P Ferguson says:

Sorry … that shOuld have been EFUDIX …
i DON’T KNOW HOW TO ALTER THE ORIGINAL POST.

June 17, 2009 at 2:17 pm
(3) Sunlvr says:

I am on the 3rd day of this trial. So far, the previous 2 appications, have resulted in redness and slight discomfort, but nothing that can’t be handled. I applied the 3rd and final dose today, so expect the discomfort to increase somewhat. I’ll post again in a day or two. Tomorrow I go in for a checkup.

June 19, 2009 at 10:45 am
(4) Sunlvr says:

Two days after I did my last dose, and it seems to be working well. There really was no additional pain, in fact pretty painless. I had it done on my forehead, and it is red and getting scaly. My eye is a bit puffy, since it was close to the eye. Looks worse than it feels. All in all good up to this point.

June 21, 2009 at 12:42 pm
(5) skincancer says:

Thanks for the interesting feedback, Sunlvr! So far, and from your one example, it looks like it avoids the side effects of the other cremes. Hopefully, the trial will be a success and it will approved soon. Let us know how things turn out for you.

June 24, 2009 at 11:49 am
(6) Sunlvr says:

Went back in on Monday for exam and another blood test. They do like taking blood during these trials. The Doctor was surprised how quickly the effected area had healed. From Thursday, it looked red, and scaly to Monday nearly all scales had gone away. You could hardly tell I had the treatment. It itches just a bit, but the skin feels good. I still have to go back three more times for photos, and of course another blood test, but all in all, if this gets FDA approval, I would definitely use it on my scalp. Not so sure on the face though.

July 2, 2009 at 1:39 pm
(7) Lynn G says:

This is exciting news. I so wish I would have known about that trial and had been able to be a apart of it. I want this treatment instead of Aldara or Mohs. It just makes more sense all the way around! Any ideas how I can get my hands on that gel?

July 22, 2009 at 9:30 am
(8) Sunlvr says:

According to the Doc, the trial will be extended another year, so probably won’t be approved until 2011. I will be in line for it though when it is available. You may find a trial site somewhere on line. I live in NM.

July 25, 2009 at 1:41 pm
(9) Lynn G says:

I know they are opening yet another trial for trunk/body. They have the link to all clinical trials on their site. The closest one to me was in California but enrollment closed early. The study filled very quickly! I am slated to do Aldara in about 2 weeks. I really do not want to do it! How are you doing now Sunlvr?

July 28, 2009 at 9:37 am
(10) Sunlvr says:

Lynn,

Doing great, will go in for one more photo and blood test, then be done. They are going to talk to me about continuing the study as they want to check it periodically for the next year. I will probably do it, though it’s a 20 mile drive to the clinic. But again, I am excited about the product, and will definitely try to get a dermo to prescribe for me when available.

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