Where is the Hydroquinone? Regulatory Change Hinders Access - Practical Dermatology
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PRACTICAL DERMATOLOGY® NEWS
>>PRACTICAL DERMATOLOGY® NEWS
VOLUME 17, NO. 11 • NOVEMBER 2020
CONTENTS
and was generally well-tolerated.
All good practice interventions identified from the centres were mapped
across the patient pathway
EXECUTIVE
SUMMARY
DATA CONFIRM EFFICACY,
SAFETY OF NUTRAFOL FOR
03b Treatment & management MENOPAUSAL WOMEN
Non-medical management, including
involvement with:
― Occupational therapist
Administration of Nutrafol’s
01 Awareness & Presentation
Awareness in patients and especially
― Psychologist
― Nurse
― Social worker
Women’s Balance formulation is safe
in primary care physicians (PCPs) to
detect atopic dermatitis and possible
suspected comorbidities and effective for improving hair growth
and quality in women going through
menopausal transition, according
02b to new data presented in a poster
02a Diagnosis
Referral 04
Initial screening by
dermatologist / paediatric
Referral via the following
pathways:
— Primary care
03a Follow-up
Programmed or patient-
presentation at the Annual Meeting of
dermatologist, trainee
dermatologist or MA
Conduct tests (e.g. patch
— Self-referral
— Another specialty to secondary
care for specialist assessment
Treatment & management
Medical management
initiated follow-up
Dermatologist, nurse and
comorbidity specialist
the American Society for Dermatologic
and prick tests) to
aid diagnosis
Investigation and review by
— Management of AD using topical
treatments, conventional systemic
treatments and biologics
periodic review
Surgery (ASDS). The six-month double-
blind, randomized, placebo-controlled
dermatologist — Management of AD and associated
comorbidities by dermatologists /
Confirmation of diagnosis paediatric dermatologists and
comorbidity specialists e.g. allergists,
pulmonologists, nutritionists
study is the first to specifically assess
© 2020 KPMG LLP, a UK limited liability partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG
a hair supplement for menopausal
women, Nutrafol says.
11 | Improving Quality of Care in AD International”), a Swiss entity. All rights reserved
put all those approaches into one docu- could do this in a 10-minute visit with Use of the Nutrafol’s Women’s
ment and look for common themes is your patient—or you can make big Balance formulation supplement
extremely powerful. Then someone like structural changes to your clinic to see resulted in statistically significant
me out in the middle of nowhere can the most severe patients and provide improvements compared to placebo
access this document…and say, ‘Okay, the most optimal care.” for the number of terminal, vellus,
here’s the steps I can do to improve and total hairs and shedding at day
my patient care with patients with this FDA GRANTS PRIORITY REVIEW 90 with further improvement at day
chronic disease,’” Dr. Simpson says. FOR PFIZER’S JAK1 INHIBITOR 180. Blinded Investigator Global Hair
The report identifies challenges but ABROCITINIB Assessments of both hair growth and
is largely focused on solutions. “One The FDA has granted Priority Review quality showed progressive and signifi-
of the top challenges that was pretty designation to Pfizer’s New Drug cant improvement for Nutrafol com-
much universal was patient understand- Application (NDA) for abrocitinib pared with placebo. Subjects reported
ing of the disease—it’s education,” Dr. (100mg and 200mg), an investigational high preference for the oral supple-
Simpson observes. Atopic dermatitis is oral once-daily Janus kinase 1 (JAK1) ments versus topical hair products.
a complex, chronic disease that is not inhibitor, for the treatment of moder- “To our knowledge, this is the first pro-
fully understood by doctors. “Trying to ate to severe atopic dermatitis (AD) spective study showing clinical efficacy of
package that into a way for patients to in patients 12 and older. A decision is a nutraceutical supplement in improving
understand, it’s quite difficult,” he says. expected in April 2021. hair growth in women with thinning hair
One identified best practice in The European Medicines Agency in menopausal transition and beyond,”
eczema care is increased utilization of (EMA) has also accepted the observes study co-author Sophia Kogan,
patient reported outcomes (PROs). Marketing Authorization Application MD, Co-founder and Chief Medical
“You can only get so much by your (MAA) for abrocitinib in the same Advisor at Nutrafol.
examination of the skin. You don’t patient population with a decision
really know how it’s impacting a anticipated in the second half of 2021. LABEL UPDATE FOR ENSTILAR
patient in terms of symptoms unless The filings were based on results of FOAM HIGHLIGHTS LONG TERM
you spend some time or utilize PROs. a robust Phase 3 clinical trial program, USE IN ADULTS
Actually PROs can save you time in across which abrocitinib demonstrated The US Prescribing Information
your clinic,” Dr. Simpson suggests. statistically superior improvements in (USPI) for Enstilar (calcipotriene and
“Another thing I like about this skin clearance, disease extent, and sever- betamethasone dipropionate) Foam
initiative is that some of these steps ity, as well as rapid improvements (mea- from LEO Pharma A/S now includes
that you can take have different levels sured as early as Week 2) in itch versus data on long-term use in adults with
of difficulty. You can pick the easy placebo. Abrocitinib also demonstrated plaque psoriasis.
ones that you could do quickly—you a consistent safety profile across trials The update results from FDA approval
10 PRACTICAL DERMATOLOGY NOVEMBER 2020
PRACTICAL DERMATOLOGY® NEWS
>>PRACTICAL DERMATOLOGY® NEWS
VOLUME 17, NO. 11 • NOVEMBER 2020
(Continued from page 11)
INSPIRE INSIGHTS WITH PRACTICAL DERMATOLOGY®
Your Patients Are Talking About… Natural Remedies for Psoriasis
To help readers better understand the issues that patients with
skin diseases face, Practical Dermatology® partnered with Inspire.
With more than 100 national patient organization partnerships and
over two million members, Inspire is a vital social network that
enables safe sharing of health experiences and social support.
Natural remedies for psoriasis are common discussion topics
for Inspire members. From sunlamps, supplements, to stress
reduction these remedies may be supplemental to current
treatments or used independently: 36.7 percent of Inspire
psoriasis members search for natural remedies.
One Inspire member shares their experience: “I use light
therapy for my psoriasis. It’s been very effective for me.”
“I’m often asked by my patients about ‘natural’ or
‘naturopathic’ remedies for psoriasis,” says Bruce Strober MD,
PhD, Co-founder of Central Connecticut Dermatology, with offices
throughout Connecticut and Clinical Professor of Dermatology
at Yale University School of Medicine in New Haven, CT. “I never
dissuade them from trying these approaches, but my experience
when seeing these patients in follow up is nearly universally
disappointing—not from a safety point of view, as I don’t doubt
these interventions are relatively safe.”
However, he says, psoriasis is a serious condition with a
well-defined immunologic cause that requires very serious,
scientifically validated therapies. “‘Natural’ approaches are the
opposite and are most likely to be snake oil—elixirs and salves
designed to prey on patient desperation and earn a buck for their
purveyors and don’t work any better than placebo.”
and high-intensity focused electromagnetic waves to build
muscle,” says Ron Borsheim, VP of Product Development
at BTL. “Heating the muscles while burning fat allows for
synergistic effects that result in more fat reduction and
muscle growth than any single gold standard procedure.
We are thrilled about the results of seven new clinical
studies that show an average of 30% fat reduction and/or
25% increase in muscle mass.”
Four treatments are recommended over the course of
four weeks. n
22 PRACTICAL DERMATOLOGY NOVEMBER 2020You can also read
