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    SKs concern patients

    Investigational topical may meet a certain therapuetic need

    Patients might be more bothered by seborrheic keratoses than they let on, and chances are they’d like to have the lesions removed.

    In a study published online in March, Las Vegas dermatologist James Q. Del Rosso, D.O., reports that many patients are bothered and concerned by seborrheic keratoses (SKs). Often they don’t like how they look, and many worry the lesions could be malignant.1

    In the study of 406 adult patients, 61% tried to disguise or cover their SKs by avoiding certain clothing types or using makeup or hairstyles to cover the lesions. Eighty-six percent of patients were extremely or somewhat interested in treating their SKs.

    Dermatologist Gary Goldenberg, M.D., an assistant clinical professor of dermatology at Icahn School of Medicine at Mt. Sinai Hospital, in New York City, says he thinks dermatologists know patients don’t like SKs. The problem is, the options for removing them are limited.

    “[SK] treatments we use haven’t really improved and are used for other indications, like actinic keratosis. And there aren’t really many good cosmetic treatments — meaning those that have good cosmetic outcomes and good safety measures,” Dr. Goldenberg says.

    Today’s options

    Dermatologists can treat SKs by cryotherapy, electrocautery, using a laser or excising the lesions, according to Dr. Goldenberg. While the options work to remove SKs, freezing, electrocautery and laser treatments might leave patients with hypopigmentation at the treatment site. Excision often leaves a visible scar.

    Offering patients a treatment for cosmetic reasons that leaves depigmentation or a scar is not desirable for obvious reasons, Dr. Goldenberg says.

    In the pipeline

    Drs. Del Rosso and Goldenberg have ties to Aclaris Therapeutics, a company with a pipeline topical that could meet the need for a cosmetically pleasing option in the treatment of SKs.

    On May 9, Aclaris announced that the FDA had accepted its New Drug Application for its investigational A 101 40% topical solution, a high-concentration hydrogen peroxide formulation for treatment of SK. The medication penetrates into the SK lesion, causing oxidative damage and, ultimately, results in the sloughing of the SK cells. If approved, A-101 40% would be the first FDA-approved topical SK treatment in the United States.

    “It’s an investigational topical solution that we would apply in the office to treat lesions, if approved. You basically paint the solution onto the lesion. If you look at the data, the product has a good safety record and a fairly robust efficacy, so I think that’s something that patients are certainly going to appreciate,” Dr. Goldenberg says.

    In November last year, the company announced results from two pivotal phase 3 trials on A 101 40%.2 A total 937 SK patients were enrolled at 34 U.S. centers. Of those, 467 received A-101 40% and 470 a placebo. Researchers assessed clearance of SK lesions using the Physician Lesion Assessment rating scale and found, overall, 51.3% of lesions treated with A-101 were assessed as clear or near clear at trial completion versus 7.3% of lesions in the placebo arm.

    Best practices for now

    There are steps dermatologists can take to reduce complications, including scarring and depigmentation, with the SK treatment options available today, according to Dr. Goldenberg.

    When he uses cryosurgery to treat SK, Dr. Goldenberg says he proceeds very carefully and tends to undertreat. Sometimes, patients have to come in multiple times for treatment.

    “I tend to under-freeze, as opposed to over-freeze. The reason for that is that melanocytes are much more sensitive to cold temperatures than keratinocytes, which are the cells that make up seborrheic keratosis,” he says.

    Dermatologists have to kill local keratinocytes in order to rid the patient the SK. Doing cryosurgery slowly and carefully helps to avoid also killing area melanocytes and leaving the patient with hypopigmentation, he says.

    The same goes for his use of electrocautery to treat SK lesions. He goes slowly and carefully because heat can cause scarring and hypopigmentation.

    Even trichloracetic acid (TCA) can destroy SK. But, that too can be a slippery slope, especially for thicker lesions, Dr. Goldenberg says.

    “The problem with all these things is that they’re not very well controlled, so, while I can do them, I’m concerned about the effect patients are going to have when it’s all done,” he says. “So, in my practice, I tend to undertreat patients because I’d rather have them come back and get retreated. Sometimes, it’s multiple times as opposed to having a scar or hypopigmentation.”

    Communicating coverage

    Communicating effectively with SK patients is also important, according to Dr. Goldenberg. Many don’t realize that removal of SK lesions isn’t covered by insurance.

    “We need to have a discussion with them that these need to be removed for a cosmetic reason, which is not covered by insurance,” he says.

    Dr. Goldenberg, who participated in the study by Dr. Del Rosso, says patients don’t always talk about how bothered they are by these lesions. It’s ok, he says, for dermatologists to broach the topic during skin checks, for example, first letting the patient know it’s benign, then letting the patient know it can be treated.

    “A lot of patients will say they didn’t know there were available treatments, so they didn’t want to ask,” he says.

    He’ll also tell patients that there’s a promising topical that might be approved by the FDA, if they aren’t comfortable with potential side effects from what’s available to treat SKs today.

    “It’s important for us to have different options for patients. Maybe this product isn’t appropriate for every patient but certainly what we have available now isn’t right for every patient. Having something available in our office that we can use safely, effectively and easily would be very helpful,” he says.

    Disclosure: Dr. Goldenberg is a consultant to Aclaris Therapeutics.

    References:

    1 Del Rosso JQ. A Closer Look at Seborrheic Keratoses: Patient Perspectives, Clinical Relevance, Medical Necessity, and Implications for Management. The Journal of Clinical and Aesthetic Dermatology. 2017;10(3):16-25.

    2 Aclaris Therapeutics Announces Positive Top-Line Phase 3 Results for A-101 In Treating Seborrheic Keratosis, a Common Undertreated Skin Condition.; November 15, 2016. Available at: https://globenewswire.com/news-release/2016/11/15/890327/0/en/Aclaris-Th....

    Lisette Hilton
    Lisette Hilton, president of Words Come Alive, has written about health care, the science and business of medicine, fitness and wellness ...

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