Recent Developments

International Council of Dermatologists Introduces New Method of Determining Psoriasis Severity

A new method to classify psoriasis severity can determine the appropriate course of treatment, according to a consensus paper by the International Psoriasis Council (IPC).

The paper is published in the Journal of the American Academy of Dermatology.

“There’s a lot of unnecessary suffering among psoriasis patients due to ‘under-classifying’ the severity of the disease. This new approach to assess psoriasis severity developed by an IPC-led Delphi exercise aims to help providers everywhere start their patients on the appropriate treatment, and sooner,” says Bruce Strober, MD, PhD, assistant clinical professor at Yale University, head of Central Connecticut Dermatology Research, and secretary-treasurer of the IPC Board of Directors. Dr. Strober is the lead author on the new consensus paper.

Previous methods of determining psoriasis severity and subsequent treatment focused on identifying patients as mild, moderate, or severe, depending on the percentage of body surface area (BSA) with active psoriasis or by using the Psoriasis Area Severity Index (PASI), but these approaches do not readily take into account the impact of psoriasis on special areas of the body such as face, nails, scalp, hands/feet, and genitals, nor does it consider how patients have responded to topical therapies. As a result, people with psoriasis—especially those with certain mild to moderate (lower severity) forms of the condition—are denied access to critical systemic treatments to control symptoms.

The International Psoriasis Council method of assessing psoriasis severity is a treatment-first approach that significantly simplifies the process of getting psoriasis patients on the right medication for their disease level.

Rejecting the mild, moderate and severe labels used to categorize psoriasis severity, the IPC method calls for classifying patients as candidates either for topical therapy or systemic therapy.

To qualify for systemic therapy, patients must meet one or more of the following criteria:

• Psoriasis lesions on 10% or more of their body surface; or
• Psoriasis lesions on sensitive areas of the body (i.e., hands/feet, face, genitals, scalp); OR
• Topical therapy failed to control symptoms.

“So far patients with less involvement than PASI 10 or BSA 10 were not eligible for a treatment with a biologic in many countries, although they may suffer quite a bit from their disease. This new approach to classifying psoriasis severity furthers IPC’s work to help improve the health of psoriasis patients around the world,” says Peter van de Kerkhof, MD, PhD, chief medical officer of International Psoriasis Council.

From this consensus paper, IPC intends to work with health insurance entities, health care providers and with stakeholders involved in the drug development process to integrate this new method of assessing psoriasis severity into standards of care for psoriasis with the ultimate aim to increase access to care for patients worldwide.

Aczone 7.5% Gel Now Approved Down to Age 9

The FDA has approved the expanded indication for Almirall’s Aczone® 7.5% Gel to include patients aged 9-11. Aczone 7.5% Gel was previously approved in February 2016 to treat inflammatory and non-inflammatory acne in patients 12 and older.

The expanded approval is based on data from an open-label safety study to assess safety, pharmacokinetics, and treatment effect of Aczone Gel, 7.5% in 101 patients 9 to 11 years of age with acne vulgaris; Aczone 7.5% Gel was determined to be safe and effective.

“While acne may be commonly thought of as an issue for teenagers, according to treatment guidelines, acne is also prevalent in children under the age of 12,” explains clinical study investigator and pediatric dermatologist, Adelaide Hebert, MD, of McGovern Medical School at UTHealth Houston. “Research revealed that treatment options like Aczone® 7.5% Gel can be used in these younger individuals who are living with the detrimental effects of acne.”

Aczone 7.5% Gel is one of 13 branded products marketed in the US by Almirall, a global family-owned company focused on medical dermatology and skin health. Ron Menezes, President and General Manager at Almirall, LLC, says, “We are very pleased to announce this expanded indication for Aczone 7.5% Gel which further demonstrates Almirall’s commitment to our patients and to continuous innovation in medical dermatology.”

Skin Cancer Foundation: Website Refresh, Gala Announced

The Skin Cancer Foundation’s website has a new look. The site is redesigned to ease navigation and provide visitors with an improved user experience.

Nearly 9 million people visit SkinCancer.org annually, and the organization says it continually strives to improve the online resources it has to offer.

The new Foundation site features a modern design and easy access to the lifesaving information The Skin Cancer Foundation has been known for since it was founded in 1979. Content on the different types of skin cancers, disease prevention, risk factors, warning signs and treatment has been refreshed and medically reviewed by 20 dermatologists, surgeons and oncologists. Visitors can be assured they’re getting the latest, most accurate information available.

The Foundation also has launched a new website for medical professionals. Provider.SkinCancer.org features the Foundation’s clinical education publications, along with physician membership and professional event information.

The Skin Cancer Foundation’s annual Champions for Change Gala comes to The Plaza New York City October 17. It is the signature fundraising event for The Skin Cancer Foundation’s programs and initiatives.

Awards are given to the Foundation’s “Champions”—individuals or corporate supporters committed to the Foundation’s goal of changing behaviors and saving lives through skin cancer education. This year marks the 40th Anniversary of the Skin Cancer Foundation.

Information on the Gala and RSVP are available at skincancer.org/gala.

Galderma Is Now Independent Dermatology Company

It’s official. Galderma is going it alone after completion of CHF 10.2 billion acquisition of Nestlé Skin Health, first announced in May 2019.

The acquisition, led by a consortium comprising the EQT VIII fund (“EQT”), Luxinva (a wholly-owned subsidiary of Abu Dhabi Investment Authority, “ADIA”), PSP Investments and other investors, was completed following exclusive negotiations with Galderma’s previous owner, Nestlé S.A. (“Nestlé”).

Founded in 1981 and operated as a wholly owned subsidiary of Nestlé since 2014, Galderma offers a range of medical and consumer skin health solutions through three business units: Aesthetics, Prescription and Consumer Care, with combined revenues of CHF $2.8 billion and approximately 5,000 employees worldwide.

Going forward, Galderma will continue to increase presence in the US and China, launch new products and focus on international expansion. The company will keep its headquarters in Switzerland.

The Company’s Management Team and Board includes Flemming Ornskov, MD, MPH and Thomas Dittrich.

Dr. Ornskov assumes the position as CEO from Stuart Raetzman, who after having led Galderma and prepared the Company for its separation from Nestlé, now joins the Company’s Board. He previously led the transformation of biopharmaceutical company Shire to become the global leader in rare diseases. “The management and team at Nestlé Skin Health have done an excellent job creating a high-growth, leading dermatology business. I believe that Galderma, as a newly focused pureplay dermatology business, has outstanding prospects built on its existing quality portfolio, team and rich pipeline of innovation. I look forward to working with the talented Galderma team to further build on its success to date,” Dr. Ornskov says in a news release.

Mr. Dittrich joins Galderma as CFO, after co-leading Shire’s strong growth and cash flow generation as CFO. The Company’s Board will also include Thomas Ebeling, former CEO of Novartis Pharma, Novartis Consumer Health and ProSiebenSat1Media AG, as Chairman, and Sheri McCoy, former CEO of Avon Products and former Vice Chairman of Johnson & Johnson as a Director.

Positive Top Line Results from Second Phase 3 Study of Abrocitinib for Atopic Dermatitis

Positive top-line results from a second Phase 3 pivotal study show the efficacy and safety of Pfizer’s investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib, in patients aged 12 and older with moderate to severe atopic dermatitis (AD). This is the second monotherapy trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program (B7451013, or JADE MONO-2). JADE MONO-2 was a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of two doses (100mg and 200mg once daily) of abrocitinib monotherapy over 12 weeks.

Consistent with JADE MONO-1, results showed that by week 12 the percentage of patients achieving each co-primary efficacy endpoint and each key secondary endpoint with either dose of abrocitinib was statistically significantly higher than placebo. In addition, a statistically significant number of patients achieved a reduction in pruritus by week two, as measured by a four-point or larger reduction in itch severity measured with the pruritus numerical rating scale (NRS).

“These findings add to a growing body of evidence supporting the potential of abrocitinib to improve the lives of people living with moderate to severe atopic dermatitis,” says Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “We look forward to continued findings from the JADE program, with results from the next abrocitinib efficacy study, using an active control, becoming available in spring 2020. This will further our understanding of abrocitinib as a potential medicine for patients who suffer from this chronic condition.”

Safety results showed that both doses of abrocitinib were well-tolerated and were broadly consistent with JADE MONO-1. The frequency of treatment-emergent adverse events were 54%, 63%, and 66% for placebo, 100mg, and 200mg, respectively. The frequency of Serious Adverse Events were 1.3%, 3.2%, and 1.3% for placebo, 100mg, and 200mg, respectively. One patient with co-existing cardiovascular risk factors died from unknown etiology three weeks after completing treatment with abrocitinib 100mg once daily, which was deemed unrelated to the study drug by the investigator. The discontinuation rates due to an adverse event were low in each treatment arm (3.8 percent and 3.2% percent in 100mg and 200mg, respectively) compared to placebo (12.8 percent).

Study: Recell System Plus Dermabrasion Speeds Acne Scar Healing

When combined with dermabrasion, the RECELL Autologous Cell Harvesting Device speeds the healing of facial acne scars, according to a study in Aesthetic Plastic Surgery.

The RECELL System uses a small amount of a patient’s own skin to prepare Spray-On Skin Cells at the point of care. It is currently FDA approved for the treatment of acute thermal burns in patients 18 years and older. In international markets, the system is approved to promote skin healing in a wide range of applications including burns, acute and chronic wounds, scars, and vitiligo.

The retrospective study analyzed the healing time and rate of postoperative complications of 78 patients with acne scars treated using dermabrasion with and without the RECELL System, revealing a statistically significant difference in healing time between the two treatment regimens.

Acne scars treated using dermabrasion healed more quickly on average with RECELL (5.27 ± 1.086 days) than without RECELL (average healing time of 12.30 ± 1.725 days). In addition, there were no postoperative complications, such as pigmentation and scar hyperplasia, and higher patient satisfaction rates (P< 0.001) for those patients treated with RECELL, the study showed.

Positive Results for Aclaris Therapeutics’ A-101 45% Topical Solution in Pivotal Phase 3 Trial for Treating Warts

Aclaris Therapeutics, Inc., shared positive results from its Phase 3 clinical trial, THWART-2 (WART-302), of A-101 45% Topical Solution, an investigational new drug for the treatment of common warts (verruca vulgaris). A-101 45% Topical Solution met the primary and all secondary efficacy endpoints, achieving clinically and statistically significant clearance of common warts. A-101 45% Topical Solution is a proprietary high-concentration hydrogen peroxide topical solution being developed as a potential prescription treatment for common warts.

THWART-2 is one of two randomized double-blind vehicle-controlled Phase 3 pivotal trials conducted by Aclaris to evaluate A-101 45% Topical Solution as a potential treatment for common warts. Aclaris expects to report data from THWART-1 (WART-301), the second Phase 3 trial during the fourth quarter of 2019. Both trials evaluated the efficacy and safety of A-101 45% Topical Solution as compared to placebo (vehicle). The two randomized, double-blind, vehicle-controlled trials were designed to demonstrate the efficacy and safety of A-101 45% Topical Solution for the potential treatment of common warts when applied by subjects (or the parents/guardians of subjects < 18 years).

In the THWART-2 trial, 502 subjects who had one to six warts at baseline were randomized and self-administered either A-101 45% Topical Solution or vehicle twice a week over 8 weeks, for a total of 16 treatments. The trial achieved its primary endpoint with a high degree of statistical significance (p<0.0001), i.e. a higher proportion of subjects treated in the A-101 45% arm versus vehicle had all their identified common warts reported as clear at Day 60. Warts were assessed using the Physician Wart Assessment scale (PWA=0) which is a validated four-point scale of the investigators’ assessment of the severity of all treated warts.

In the trial, all secondary efficacy endpoints achieved statistical significance in favor of A-101 45% Topical Solution versus vehicle and are described as follows:

• Complete clearance of all warts at Day 137 (12 weeks after last treatment) (p=0.0001)
• Mean per subject percent of treated warts cleared at Day 137 (p<0.0001)
• Clearance in subjects with a single baseline wart at Day 60 (p=0.0006)
• Time to complete clearance of all warts (p<0.0001)

There were no treatment-related serious adverse events (SAEs) in subjects treated with A-101 45% Topical Solution. Treatment-related application site adverse events (AEs) were reported in 53.4% and 8.4% of the A-101 45% Topical Solution and vehicle groups respectively. In the active arm 2% (5 subjects) of application site events were severe (1 pain, and 4 site pallor). The most common AEs (occurring in more than 5% of subjects) were application site pain, pallor, erythema, pruritus, scabbing and erosion. No subjects withdrew because of AEs.

Study Finds Long-Term Use of Brodalumab Is Safe, Effective

Long-term use of brodalumab (SILIQ) improved skin clearance and quality of life in patients with moderate-to-severe psoriasis, according to a new study in the American Journal of Clinical Dermatology.

Overall, 181 patients received brodalumab for a median of 264 weeks. Brodalumab treatment resulted in rapid improvements in Psoriasis Area and Severity Index (PASI), Static Physician’s Global Assessment (sPGA) and dermatology life quality index (DLQI) that were maintained through week 264. Overall, the study found that at brodalumab demonstrated skin clearance and improved quality of life, with an acceptable safety profile, throughout five years of treatment.

Pediatric Dermatologist Who Co-Founded Camp for Children Recognized for Care

The American Academy of Dermatology honored dermatologist Karen Wiss, MD, FAAD, as a Patient Care Hero for her role in treating a patient with recessive dystrophic epidermolysis bullosa (RDEB).

To support pediatric patients with isolating conditions like RDEB, Dr. Wiss, a dermatologist at UMass Memorial Health Care and professor at the University of Massachusetts Medical School, co-founded the Connecticut location of Camp Discovery, a sleepaway camp for children with chronic skin diseases organized by the American Academy of Dermatology.

Both the camp and Dr. Wiss’ care have been crucial for Connecticut resident and RDEB patient Jonathan Gionfriddo, who is now a senior counselor and the host of the camp talent show.

“It’s hard to find people who can truly understand what my life is like and what I’m going through. Together, Dr. Wiss and Camp Discovery helped me realize I wasn’t the only person struggling with my disease, which improved my confidence,” MR. Gionfriddo says in a news release. “Being treated by people who not only know how to physically treat my condition, but also listen, encourage and support me when I advocate for myself, makes a huge difference.”

Working with Gionfriddo led Dr. Wiss and her colleagues to publish a journal article in Pediatric Dermatology on how to safely adapt hospital care for children with RDEB.

“I am consistently inspired by Jonathan’s courage and enthusiasm. Through it all, he’s been both a strong advocate at our hospital and a true role model for everyone at Camp Discovery,” Dr. Wiss says. “Jonathan has helped us provide better and more holistic care, and it’s incredibly rewarding and special to see him grow into a mentor for others.”

The AAD created the Patient Care Heroes program to recognize physicians who transform patients’ lives by utilizing their expertise and collaborating with other physicians to treat serious skin disease.

“The social isolation that many skin diseases create for patients can often be overlooked,” says dermatologist George J. Hruza, MD, MBA, FAAD, president of the AAD. “Dr. Wiss’s efforts to not only physically treat patients like Jonathan, but to also address their social, mental and emotional health needs, is a model for our field.”

With New Funding, Turn Therapeutics Will Launch Phase 4 Study of AD Drug

Turn Therapeutics has closed its fully-subscribed series B financing.

The capital raised will fund a large-scale, pre-launch, phase 4 trial for AtopX Eczema Emulsion, with enrollment scheduled to begin in Q1 2020. The series B financing will also support advancement of additional infectious disease and dermatology programs based on Turn’s proprietary PermaFusion™ technology platform.

“AtopX is an extensively-studied, well-tolerated, non-steroidal, FDA cleared product indicated for the management of atopic, irritant, and radiation dermatitis,” says Bradley Burnam, CEO of Turn Therapeutics, in a news release.”With this new capital, we will commence a large-scale, phase 4 trial specifically for the management of atopic dermatitis that will support the planned launch of AtopX in this high-need space.”

The phase 4, adaptive trial design will assess safety and efficacy of AtopX in moderate to severe eczema patients as its primary endpoint, as well as employ the traditional quality of life and comfort indexes typical of such trials. In addition, the company will continue to advance its pipeline infectious disease and dermatology programs, including new drug candidates to treat shingles of the eye and onychomycosis.

The Series B round included investment from existing investors and new, high-level family office investors with expertise in the biotech space. The round closed on September 30, 2019. up.”

L’Oréal USA Announces Winners Of 2019 Women In Digital Next Generation Awards

L’Oréal USA announced the winners of the 2019 Women in Digital NEXT Generation Awards.

The three winners, each of whom will receive $25,000 in grant funding, include Mandi Nyambi and Lanya Olmsted, the co-founders of Baalm, an online community for beauty; Lisha Li, the founder of Rosebud AI, a technology that lets users virtually try-on makeup, hairstyles and clothes from any social media photo; and Alyssa Min and Sunny Kim, the co-founders of Seknd, a smart beauty discovery platform for personalized product recommendations. All Women in Digital NEXT Generation Award winners have been invited to L’Oréal USA’s New York City headquarters to meet with executives and attend on-site events.

The program—now in its seventh year—supports female leaders who are building technologies that have the potential to revolutionize the beauty industry. L’Oréal USA also created an inclusive, virtual Women In Digital community on the Alice platform that will continue to exist year-round as a resource for participating entrepreneurs from all over the United States.

Electric Tech May Help Reverse Baldness

Reversing baldness could someday be as easy as wearing a hat, thanks to a noninvasive, low-cost hair-growth-stimulating technology developed by engineers at the University of Wisconsin–Madison.

Xudong Wang, a professor of materials science and engineering at UW–Madison. and colleagues published a description of the technology in ACS Nano.

Based on devices that gather energy from a body’s day-to-day motion, the hair-growth technology stimulates the skin with gentle, low-frequency electric pulses, which coax dormant follicles to reactivate hair production.

The devices reactivate hair-producing structures that have gone dormant. That means they could be used as an intervention for people in the early stages of pattern baldness. Because the devices are powered by the movement of the wearer, they don’t require a bulky battery pack or complicated electronics. In fact, they’re so low-profile that they could be discreetly worn underneath an everyday baseball cap.

Wang has pioneered electric bandages that stimulate wound-healing and a weight-loss implant that uses gentle electricity to trick the stomach into feeling full.

The hair-growth technology is based on a similar premise: Small devices called nanogenerators passively gather energy from day-to-day movements and then transmit low-frequency pulses of electricity to the skin. That gentle electric stimulation causes dormant follicles to “wake up.”

Because the electric pulses are incredibly gentle and don’t penetrate any deeper than the very outermost layers of the scalp, the devices don’t seem to cause any unpleasant side effects. That’s a marked advantage over other baldness treatments, like the medicine Propecia, which may carry risk of sexual dysfunction, depression and anxiety.

What’s more, in side-by-side tests on hairless mice, the devices stimulated hair growth just as effectively as two different compounds found in baldness medicines.

The researchers have patented the concept with the Wisconsin Alumni Research Foundation, and they hope to move forward with human testing soon.