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NEWSVolume 13, No. 7 • July 2016

SPECIAL REPORT

Itching for AnswersActress Vicki Lawrence opens up about her CIU diagnosis.

BY DENISE MANN

If Thelma Mae Harper (aka “Mama” of Carol Burnett Show and Mama’s Family fame) or any of her family members were to develop chronic hives, the matriarch would likely be unfussed and unfazed.Not Mama’s portrayer, Emmy Award-winning actress and

comedienne Vicki Lawrence. “I don’t imagine Mama could be bothered with the hives. She would say I was a nutbasket for sure,” says Lawrence, who is reprising her memorable role onstage for Vicki Lawrence & Mama: A Two-Woman Show.

Lawrence was diagnosed with chronic idiopathic urticaria (CIU) six years ago and her sense of humor—along with red wine—certainly helped her get through it, but CIU is no laughing matter. This is why Lawrence is speaking up and speaking out as part of the CIU and You Campaign, in part-nership with the Asthma and Allergy Foundation of America (AAFA) and made possible by Novartis Pharmaceuticals Corporation and Genentech.

In the US, around 1.5 million people develop CIU, and women are twice as likely to get CIU as men, according to CIU and You. Despite this, Lawrence felt completely alone at first.

“I woke up with the palms of my hands itching,“ she recalls. “I thought this is really funny. We must be coming into a lot of money,” she says, referencing a superstition that an itchy left palm means money is on the way.

To relieve the itch, she plunged her hands into ice water. And it worked … for the time being. “I woke up the next morning with my hands itching again. It was like Groundhog Day,” says Lawrence, who also appeared on Hannah Montana. “A little later I was walking the dogs, and I felt the itch crawling up my arms and abdomen and I wanted to go jump in the bay.”

Her first thought was that she was having an allergic reac-tion to something, “maybe a bad shrimp or a new perfume.”

But that was not the case. All allergies were ruled out, yet her hives remained present and accounted for. “I would sit on the bed and see how long I could go without scratching,” she says. “They would get bigger like welts, and then islands, and then the islands would merge into continents.”

Everyone had suggestions on how she could stop the itch and hives. “Someone told me to stop drinking red wine and I remember thinking red wine is the only thing getting me through this mess.”

It did seem like heat made things worse, she says. “I’d take cold showers and jump out freezing and then rub menthol lotion on my body, hoping the hives would settle down. It was a long time before I would take a warm shower again. The struggle is very real.”

After six weeks, her doctor said ‘I think you have chronic idiopathic urticaria,” she says. “I think I laughed because I had never heard such a mouthful.”

Searching for a cause proved frustrating and disheartening, she says. To help others with CIU, “I contacted the AAFA and helped put together a new education program for people who think this might be them to help them take charge and be a little bit more proactive,” she says. The campaign pro-vides downloadable materials to track and take pictures of the hives so that patients are armed when they visit the doc-tor, especially if they are in remission at that time.

“There are a lot of doctors who are not familiar with CIU,” she says. “I was fortunate that my doctor knew what it was.”

DIAGNOSING CIUGary Goldenberg, MD, an assistant clinical professor of

Dermatology at Icahn School of Medicine and the Medical

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NEWS

Director of the Dermatology Faculty Practice at Mount Sinai in New York City, has experience treating CIU. “This is one of the more frustrating conditions for patients because it is idiopathic and it is chronic and can be relapsing and remitting,” he says. “Patients get better and feel like they are over it and then it comes back. CIU is very unpredictable and can cause horrendous itching.”

The first step in diagnosing CIU is a careful review of all systems. “Ask all the right questions about possible triggers including food allergies or medication reactions. Patients may need a referral to allergist,” he says. “You can’t make a diagno-sis of CIU until any organic possible causes are ruled out.”

Often times there is no known cause, but it is possible that autoimmunity is driving some cases of CIU, adds Peter A. Lio, MD, FAAD, a professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine in Chicago.

“The more recent development has been the idea of auto-immunity being an important cause of chronic urticaria: autoantibodies against the high affinity immunoglobulin E (IgE) receptor (FcεRI) seem to drive this chronic urti-caria and some have said that calling it ‘Chronic Immune-mediated Urticaria’ might be a better name than the Chronic Idiopathic Urticaria when this is known to be at play,” he explains.

“This is a very frustrating condition for both patients and physicians. The hardest part is that only for a small group are we ever able to find a clear trigger,” Dr. Lio says. “For those patients, things are fairly easy: just avoid the trigger and you are hive-free! But for everyone else, it is generally not possible to find what is driving it. That is why the under-standing that it is autoimmune in some cases comes as a welcome relief: finally people can stop searching and testing, and can get on to treatment.”

For most cases, antihistamines, usually in combination, are used with varying success, Dr. Lio says. “For refractory cases, more powerful systemic agents such as cyclospo-rine can be of tremendous help, but also carry significant side effect risks. More recently, XOLAIR (omalizumab), a humanised monoclonal antibody that binds to circulating immunoglobulin E and reduces the release of inflammatory mediators from mast cells has been approved for CIU with impressive results.”

Given by injection every 4 weeks, XOLAIR is used to treat CIU in patients whose symptoms are not controlled by H1 antihistamines at approved doses.

“Omalizumab has been highly effective for these difficult cases and appears to be relatively safe. High cost and the need for monthly subcutaneous injection make it a little more difficult, but for the right patient, it has been a true game-changer,” Dr. Lio adds

Dr. Goldenberg agrees. “It’s not a cure. It’s a treatment. Treatment lasts three to six months and then we take them off. If the hives don’t come back, we keep them off, but if they return, we put them back on,” he says, adding that Xolair is fairly safe, but risks including anaphylaxis do exist. “We watch CIU patients for several hours after the injection in the office and prescribe Epipens as well.”

JULY 2016 PRACTICAL DERMATOLOGY 13

NEWS

Breaking BaldAugust is National Hair Loss Awareness Month, and

Practical Dermatology® reached out to two top dermatolo-gists to find out what is new and exciting in this field today.

Ken Washenik, MD, PhD: “There are a lot of excit-ing things going on in a field that typically moves in fits and starts. For decades, all we had in terms of drug-based treatments were Propecia (finasteride) or Rogaine (minoxidil), but today’s pipeline is robust.

There is much enthusiasm about prostaglandin analogs includ-ing Allergan’s Latisse, which is already approved for eyelash growth. Latisse is now being studied in the scalp, and we are awaiting the analysis of a Phase 2 trial that used a higher dose of the agent than earlier studies. This makes sense as the scalp is harder to penetrate than the skin around the eyelashes.

KYTHERA Biopharmaceuticals, Inc., prior to its acquisition by Allergan, submitted an Investigational New Drug Application to the FDA for KYTH-105 (setipiprant) for treatment of andro-genetic alopecia. Setipiprant is a selective oral antagonist of the prostaglandin D2 receptor. Research has found that men with male pattern baldness have elevated levels of PGD2.

It has been previously evaluated by Actelion Pharmaceuticals Ltd. in nine clinical studies as a potential allergic inflammation treatment. It is possible that prosta-glandin analogs and antagonists will be used together to treat hair loss.

In the surgery arena, many of us are seeing great results with follicular unit extraction (FUE), which allows for less detectable donor-site scarring. Follicular unit transplant (FUT) still has a role to play. There are pros and cons to both, and we are now able to match the best procedure with the best patient for the best results. In someone who wants to wear their hair super short, FUE makes sense as there is no visible scar. If you are someone who has longer hair, you may prefer FUT because of the more robust donor site. The FUT strip extraction method typically results in a very narrow linear scar in the back of the head. Robotic hair transplantation is good at making 1mm circular incisions to facilitate graft removal and remains exciting, but there will always be discourse and debate comparing the human eye and artistic aspects of hair transplantation to the tireless precision of a machine.

Another exciting area is the use of cell-based products and growth factors. At the Aderans Research Institute (ARI), we were looking at a treatment that takes cells found around hair follicles and grows them in the lab. The cells are then re-injected into the scalp to help grow hair. In our studies, approximately 60 percent of participants had more hair one year after the cell-based treatment. ARI is no longer pursuing this, but RepliCel, a regenerative medicine com-

pany based in Vancouver, BC, is developing an autologous cell therapy utilizing dermal sheath cup (DSC) cells isolated from the hair follicle to treat androgenetic alopecia. They are being backed by the cosmetics company Shiseido with plans to launch a regenerative hair loss treatment in Japan and other Asian countries in 2018.

Kerastem is also promising. This treatment relies on injections of stem cell-enriched fat to help reverse hair loss. This treatment is already CE mark approved for people with hair loss outside the US. The fat cells are extracted via liposuction, purified and then injected back into the scalp. We are currently enrolling participants for a clinical trial of Kerastem at four sites.

The use of platelet rich plasma (PRP) is also hot in hair restoration today. We draw some blood and process it by centrifugation to separate the plasma from the concen-trated platelets. We then inject the platelet-enriched plasma back into the scalp to take advantage of the fact that they are filled with growth factors. The hope is that it will rejuve-nate the hair follicles. In the next few years, we should have a host of drug-based treatments that can be used alone, in combination with each other, or with surgery to provide natural looking and exciting results.”

Ken Washenik, MD, PhD, is President and Chief Medical Director of Bosley Medical Group, and former Chief Executive Officer of Aderans Research Institute. He is a faculty member in the Department of Dermatology at NYU-Langone in New York City. He is a past President and Board member of the North American Hair Research Society, serves as Vice President of the International Society of Hair Restoration Surgery and is a Board member of the Cicatricial Alopecia Research Foundation.

Rebecca Kazin, MD: “Hair loss treatments have become more targeted to the problem over the years. They have also become less toxic. We used to give everyone steroids, but now we tend to lean toward vitamin supplements. There are also

advances in surgical options. You can now transplant much smaller amounts of hair per transplant sight so the result is more natural and it does not look like hair plugs.

There will always be a role for prevention. I advise patients to use a natural bristle brush. Plastic or artificial brushes can be aggressive with your hair and scalp. A natural brush will help limit damage. Other prevention tips include:

• Switching your hair dryer to a cooler setting. Heat is extremely damaging to hair. It might take longer to dry and style your hair but it will prevent harm.

• Never skipping the conditioning step. A nourishing con-ditioner will help soften and strengthen your hair.

• Avoiding wearing hair in a tight ponytail.

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• Not coloring your own hair. The chemical process that colors your hair actually strips and re-pigments your hair. Many home color kits contain harsh chemicals that alter the stability of the hair and weaken its integrity.

I also tell patients concerned about hair loss to consider adding leafy vegetables and eggs to your diet. It’s been shown that diets rich in calcium and iron can help reduce or prevent hair loss. Be sure to also include proteins in your diet because hair is rich in protein.”

Rebecca Kazin, MD, is a dermatologist, associate director of the Washington Institute of Dermatologic Laser Surgery, and an assistant professor of dermatology at Johns Hopkins Medicine in Baltimore.

FDA Greenlights OTC RetinoidThe FDA approved Differin Gel 0.1% (adapalene), a once-

daily topical gel for the over-the-counter (OTC) treatment of acne in people 12 years of age and older. Differin Gel 0.1% is the first retinoid to be made available OTC for the treat-ment of acne, and contains the first new active ingredient for acne treatment for OTC use since the 1980s.

Differin Gel 0.1% (Galderma Laboratories, L.P.) was approved in 1996 as a prescription product for the treat-ment of acne vulgaris in patients 12 years of age and older. Differin Gel’s safety and efficacy were initially established based on five clinical trials in people with mild-to-moderate acne. To support approval for OTC marketing, the data accrued from 1996-2016 on post-marketing safety, data from consumer studies, and data from a maximal use trial were submitted.

Overall, results from the consumer studies showed that consumers can understand the information on the OTC label, appropriately select whether the product is right for them, and use the product appropriately. The maximal use trial, a study of absorption of the drug through acne-affect-ed skin when applied daily over a large surface area, demon-strated that absorption is limited, thus safe for OTC use.

Sciton Launches New Program to Encourage Practice Growth

Sciton Inc. recently unveiled a new practice support pro-gram, Success Builder. Upon initial purchase of their JOULE laser system customers have the ability to add Success Builder points to their account, which they can later use to buy offer-ings through the program, and can also access the various services via the website: www.sciton.com/successbuilder. Through the enhanced program, customers have the ability

to take additional clinical training courses, redesign their mar-keting materials and website, and experience preferred pricing with industry partners, among many other offerings.

Neurotoxins Make Patients Feel Better About Themselves

Patient satisfaction with overall facial appearance increas-es by 28 percent with botulinum toxin type A injections to the glabellar rhytids, according to new research in the Aesthetic Surgery Journal.

Researchers examined 57 female patients who completed the FACE-Q survey, which consists of 63 questions asking patients to evaluate their overall appearance, age appearance, and the appearance of cheeks, nasolabial folds, lower face and jawline, chin, and neck. After the baseline survey, the patients received injections of one brand of botulinum toxin type A, (Botox, Dysport or Xeomin) in the region between the brows. Two weeks post-injection, the patients completed the FACE-Q survey again.

Patients said that they believe they look an average of 5.6 years younger post-injection with any of the botulinum toxin type A products, (Botox, Dysport, and Xeomin). The average age of the 57 patients with pre- and post-neurotoxin FACE-Q responses was 49.6 years (range of 32 – 75 years old).

After receiving injections, patients reported a 38 percent improvement in symmetry, 12 percent improvement in bal-ance, 31 percent improvement in appearance at the end of the day, 36 percent improvement in freshness, 47 percent increase in restfulness, 24 percent improvement in appearance of profile, 29 percent improvement in appearance in photos, 23 percent improvement in appearance when waking up, and 23 percent improvement in appearance under bright lights.

Regenica Rejuvenating Dual Serum Improves Skin Through 90 Days

A new 90-day clinical study evaluated 40 women who were asked to use Regenica Rejuvenating Dual Serum on their entire face, twice daily. Patients reported a reduction in fine lines as early as 14 days, with continued improvement seen through the duration of the study. A reduction in the appearance of coarse wrinkles and blotchiness was also reported. The study showed an increase in brightness and skin radiance, and improved appearance of skin firmness and skin elasticity. Patients report-ed an improvement in skin health and skin rejuvenation and 95 percent were satisfied with Regenica Rejuvenating Dual Serum. The primary efficacy endpoint was met for the investigator-assessed rating for overall facial skin appearance. n