Volume 13, No. 7 • July 2016 NEWS SPECIAL REPORT Itching for Answers Actress Vicki Lawrence opens up about her CIU diagnosis. BY DENISE MANN

f 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. INot 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. It did seem like heat made things worse, she says. “I’d take “I woke up with the palms of my hands itching,“ she cold showers and jump out freezing and then rub menthol recalls. “I thought this is really funny. We must be coming lotion on my body, hoping the hives would settle down. It into a lot of money,” she says, referencing a superstition that was a long time before I would take a warm shower again. an itchy left palm means money is on the way. The struggle is very real.” To relieve the itch, she plunged her hands into ice water. And After six weeks, her doctor said ‘I think you have chronic it worked … for the time being. “I woke up the next morning idiopathic urticaria,” she says. “I think I laughed because I with my hands itching again. It was like Groundhog Day,” says had never heard such a mouthful.” Lawrence, who also appeared on Hannah Montana. “A little Searching for a cause proved frustrating and disheartening, later I was walking the dogs, and I felt the itch crawling up my she says. To help others with CIU, “I contacted the AAFA and arms and abdomen and I wanted to go jump in the bay.” helped put together a new education program for people Her first thought was that she was having an allergic reac- who think this might be them to help them take charge and tion to something, “maybe a bad shrimp or a new perfume.” be a little bit more proactive,” she says. The campaign pro- But that was not the case. All allergies were ruled out, yet vides downloadable materials to track and take pictures of her hives remained present and accounted for. “I would sit the hives so that patients are armed when they visit the doc- on the bed and see how long I could go without scratching,” tor, especially if they are in remission at that time. she says. “They would get bigger like welts, and then islands, “There are a lot of doctors who are not familiar with CIU,” and then the islands would merge into continents.” she says. “I was fortunate that my doctor knew what it was.” Everyone had suggestions on how she could stop the itch and hives. “Someone told me to stop drinking red wine and DIAGNOSING CIU I remember thinking red wine is the only thing getting me Gary Goldenberg, MD, an assistant clinical professor of through this mess.” Dermatology at Icahn School of Medicine and the Medical

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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 Dr. Goldenberg agrees. “It’s not a cure. It’s a treatment. antihistamines at approved doses. Treatment lasts three to six months and then we take them “Omalizumab has been highly effective for these difficult off. If the hives don’t come back, we keep them off, but if cases and appears to be relatively safe. High cost and the they return, we put them back on,” he says, adding that need for monthly subcutaneous injection make it a little Xolair is fairly safe, but risks including anaphylaxis do exist. more difficult, but for the right patient, it has been a true “We watch CIU patients for several hours after the injection game-changer,” Dr. Lio adds in the office and prescribe Epipens as well.”

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Breaking Bald pany based in Vancouver, BC, is developing an autologous August is National Hair Loss Awareness Month, and cell therapy utilizing dermal sheath cup (DSC) cells isolated Practical Dermatology® reached out to two top dermatolo- from the hair follicle to treat androgenetic alopecia. They gists to find out what is new and exciting in this field today. are being backed by the cosmetics company Shiseido with plans to launch a regenerative hair loss treatment in Japan Ken Washenik, MD, PhD: “There are a lot of excit- and other Asian countries in 2018. ing things going on in a field that typically moves Kerastem is also promising. This treatment relies on in fits and starts. For decades, all we had in terms of injections of stem cell-enriched fat to help reverse hair loss. drug-based treatments were Propecia (finasteride) This treatment is already CE mark approved for people or Rogaine (minoxidil), but today’s pipeline is robust. with hair loss outside the US. The fat cells are extracted via There is much enthusiasm about prostaglandin analogs includ- liposuction, purified and then injected back into the scalp. ing Allergan’s Latisse, which is already approved for eyelash We are currently enrolling participants for a clinical trial of growth. Latisse is now being studied in the scalp, and we are Kerastem at four sites. awaiting the analysis of a Phase 2 trial that used a higher dose The use of platelet rich plasma (PRP) is also hot in hair of the agent than earlier studies. This makes sense as the scalp is restoration today. We draw some blood and process it by harder to penetrate than the skin around the eyelashes. centrifugation to separate the plasma from the concen- KYTHERA Biopharmaceuticals, Inc., prior to its acquisition by trated platelets. We then inject the platelet-enriched plasma Allergan, submitted an Investigational New Drug Application back into the scalp to take advantage of the fact that they to the FDA for KYTH-105 (setipiprant) for treatment of andro- are filled with growth factors. The hope is that it will rejuve- genetic alopecia. Setipiprant is a selective oral antagonist of the nate the hair follicles. In the next few years, we should have prostaglandin D2 receptor. Research has found that men with a host of drug-based treatments that can be used alone, in male pattern baldness have elevated levels of PGD2. combination with each other, or with surgery to provide It has been previously evaluated by Actelion natural looking and exciting results.” Pharmaceuticals Ltd. in nine clinical studies as a potential Ken Washenik, MD, PhD, is President and Chief Medical allergic inflammation treatment. It is possible that prosta- Director of Bosley Medical Group, and former Chief Executive glandin analogs and antagonists will be used together to Officer of Aderans Research Institute. He is a faculty member treat hair loss. in the Department of Dermatology at NYU-Langone in New In the surgery arena, many of us are seeing great results York City. He is a past President and Board member of the with follicular unit extraction (FUE), which allows for less North American Hair Research Society, serves as Vice President detectable donor-site scarring. Follicular unit transplant of the International Society of Hair Restoration Surgery and (FUT) still has a role to play. There are pros and cons to is a Board member of the Cicatricial Alopecia Research both, and we are now able to match the best procedure Foundation. with the best patient for the best results. In someone who wants to wear their hair super short, FUE makes sense as Rebecca Kazin, MD: “Hair loss treatments have there is no visible scar. If you are someone who has longer become more targeted to the problem over the hair, you may prefer FUT because of the more robust donor years. They have also become less toxic. We used site. The FUT strip extraction method typically results in a to give everyone steroids, but now we tend to very narrow linear scar in the back of the head. Robotic hair lean toward vitamin supplements. There are also transplantation is good at making 1mm circular incisions to advances in surgical options. You can now transplant much facilitate graft removal and remains exciting, but there will smaller amounts of hair per transplant sight so the result is always be discourse and debate comparing the human eye more natural and it does not look like hair plugs. and artistic aspects of hair transplantation to the tireless There will always be a role for prevention. I advise patients precision of a machine. to use a natural bristle brush. Plastic or artificial brushes can Another exciting area is the use of cell-based products be aggressive with your hair and scalp. A natural brush will and growth factors. At the Aderans Research Institute help limit damage. Other prevention tips include: (ARI), we were looking at a treatment that takes cells found • Switching your hair dryer to a cooler setting. Heat is around hair follicles and grows them in the lab. The cells extremely damaging to hair. It might take longer to dry are then re-injected into the scalp to help grow hair. In our and style your hair but it will prevent harm. studies, approximately 60 percent of participants had more • Never skipping the conditioning step. A nourishing con- hair one year after the cell-based treatment. ARI is no longer ditioner will help soften and strengthen your hair. pursuing this, but RepliCel, a regenerative medicine com- • Avoiding wearing hair in a tight ponytail.

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• Not coloring your own hair. The chemical process that to take additional clinical training courses, redesign their mar- colors your hair actually strips and re-pigments your hair. keting materials and website, and experience preferred pricing Many home color kits contain harsh chemicals that alter with industry partners, among many other offerings. 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 Neurotoxins Make Patients Feel shown that diets rich in calcium and iron can help reduce Better About Themselves or prevent hair loss. Be sure to also include proteins in your diet because hair is rich in protein.” Patient satisfaction with overall facial appearance increas- es by 28 percent with botulinum toxin type A injections Rebecca Kazin, MD, is a dermatologist, associate director to the glabellar rhytids, according to new research in the of the Washington Institute of Dermatologic Laser Surgery, Aesthetic Surgery Journal. and an assistant professor of dermatology at Johns Hopkins Researchers examined 57 female patients who completed Medicine in Baltimore. 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 FDA Greenlights OTC Retinoid jawline, chin, and neck. After the baseline survey, the patients The FDA approved Differin Gel 0.1% (adapalene), a once- received injections of one brand of botulinum toxin type daily topical gel for the over-the-counter (OTC) treatment A, (Botox, Dysport or Xeomin) in the region between the of acne in people 12 years of age and older. Differin Gel 0.1% brows. Two weeks post-injection, the patients completed is the first retinoid to be made available OTC for the treat- the FACE-Q survey again. ment of acne, and contains the first new active ingredient Patients said that they believe they look an average of 5.6 for acne treatment for OTC use since the 1980s. years younger post-injection with any of the botulinum toxin Differin Gel 0.1% (Galderma Laboratories, L.P.) was type A products, (Botox, Dysport, and Xeomin). The average approved in 1996 as a prescription product for the treat- age of the 57 patients with pre- and post-neurotoxin FACE-Q ment of acne vulgaris in patients 12 years of age and older. responses was 49.6 years (range of 32 – 75 years old). Differin Gel’s safety and efficacy were initially established After receiving injections, patients reported a 38 percent based on five clinical trials in people with mild-to-moderate improvement in symmetry, 12 percent improvement in bal- acne. To support approval for OTC marketing, the data ance, 31 percent improvement in appearance at the end of the accrued from 1996-2016 on post-marketing safety, data day, 36 percent improvement in freshness, 47 percent increase from consumer studies, and data from a maximal use trial in restfulness, 24 percent improvement in appearance of profile, were submitted. 29 percent improvement in appearance in photos, 23 percent Overall, results from the consumer studies showed that improvement in appearance when waking up, and 23 percent consumers can understand the information on the OTC improvement in appearance under bright lights. 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- Regenica Rejuvenating Dual Serum ed skin when applied daily over a large surface area, demon- Improves Skin Through 90 Days strated that absorption is limited, thus safe for OTC use. A new 90-day clinical study evaluated 40 women who were asked to use Regenica Rejuvenating Dual Serum on their entire Sciton Launches New Program to face, twice daily. Patients reported a reduction in fine lines as Encourage Practice Growth early as 14 days, with continued improvement seen through the duration of the study. A reduction in the appearance of coarse Sciton Inc. recently unveiled a new practice support pro- wrinkles and blotchiness was also reported. The study showed gram, Success Builder. Upon initial purchase of their JOULE an increase in brightness and skin radiance, and improved laser system customers have the ability to add Success Builder appearance of skin firmness and skin elasticity. Patients report- points to their account, which they can later use to buy offer- ed an improvement in skin health and skin rejuvenation and 95 ings through the program, and can also access the various percent were satisfied with Regenica Rejuvenating Dual Serum. services via the website: www.sciton.com/successbuilder. The primary efficacy endpoint was met for the investigator- Through the enhanced program, customers have the ability assessed rating for overall facial skin appearance. n

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