Therapeutics Focus: Corticosteroids

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HIGH- VS. LOW-POTENCY TOPICAL CORTICOSTEROID FOR ALOPECIA AREATA IN CHILDREN

Researchers designed a single-center, randomized, blind, two-arm, parallel-group, superiority trial to compare the efficacy and safety of a high- vs. low-potency topical corticosteroid in pediatric patients with alopecia areata. The study was carried out over a 24-week period. Forty-two children attending the outpatients clinic, two to 16 years of age with alopecia areata affecting at least 10% of scalp surface area, were eligible (one declined to participate). There were no withdrawals from the study.

Patients were randomly assigned to receive clobetasol propionate 0.05% cream, or hydrocortisone 1% cream. Patients were instructed to apply a thin layer of the assigned cream twice daily to the areas of hair loss for two cycles of six weeks on, six weeks off, for a total of 24 weeks. The primary outcome was the change in scalp surface area with hair loss over 24 weeks following enrollment.

Participants were assessed at six, 12, 18, and 24 weeks (except one participant who missed the six-week visit). The study found that after adjusting for baseline hair loss, the clobetasol group had a statistically significant greater decrease in the surface area with hair loss, compared with the hydrocortisone group at all time points except at six weeks. One patient with extensive alopecia areata experienced skin atrophy that resolved spontaneously in six weeks. No difference was observed in the number of patients with abnormal urinary cortisol at the beginning and the end of the study.

Researchers concluded that topical clobetasol propionate, 0.05% cream is efficacious and safe as a first-line agent for limited patchy childhood alopecia areata.

—JAMA Dermatol. 2014; 150(1): 47-50.

PREGNANCY OUTCOMES AFTER MATERNAL EXPOSURE TO TOPICAL CORTICOSTEROIDS

Because topical corticosteroids are indicated for pregnant women with skin conditions, but their safety in pregnancy is not fully understood, researchers in the UK investigated whether maternal exposure to topical corticosteroids results in adverse pregnancy outcomes.

Through the United Kingdom National Health Service, researchers analyzed orofacial cleft, low birth weight, preterm delivery, fetal death, low Apgar score, and mode of delivery of 2,658 pregnant women exposed to topical corticosteroid and 7,246 unexposed pregnant women. Results of the primary analysis in the retrospective study found no associations of maternal topical corticosteroid exposure with orofacial cleft, low birth weight, preterm delivery, fetal death, low Apgar score, and mode of delivery. Stratified analyses based on potency did not reveal any significant associations in most of these categories either, but the researchers found that an exploratory analysis showed a significantly increased risk of low birth weight when the dispensed amount of potent or very potent topical corticosteroids exceeded 300g during the entire pregnancy.

The researchers concluded that the study showed no associations of maternal topical corticosteroid exposure with orofacial cleft, preterm delivery, fetal death, low Apgar score, and mode of delivery, and that with this study and all available evidence taken together, the risk of low birth weight seems to correlate with the quantity of topical corticosteroid exposure.

—JAMA Dermatol. 2013;149(11):1274-1280

THE ATOPIC DERMATITIS PHARMA FORECAST: NEW COMERS AND GROWTH FOR CORTICOSTEROIDS AND MOISTURIZERS/EMOLLIENTS

Research and Markets has released “PharmaPoint: Atopic Dermatitis - US Drug Forecast and Market Analysis to 2022.”

The report shows that although the past decade has seen the atopic dermatitis market remain relatively unchanged as “a saturated, highly genericized arena, the coming decade could see the launch of the first biologic, which will set a precedent and pave the way for others to follow suit.”

By the mid-to-late term of the group's 2012 to 2022 forecast, it expects Sanofi/Regeneron's dupilumab to reshape the moderate and severe treatment landscape for atopic dermatitis.

Other events expected to invoke change to the previously stagnant atopic dermatitis market include the launch of a non-steroidal topical from Anacor, AN2728, and increasing use of pharmacological treatments in the growing markets of India and China.

The report suggests that while these classes represent the crowded, saturated, generic portion of the US atopic dermatitis market, the reliance on these agents will lead to an overall steady growth over the 10-year forecast period, with respective CAGRs of 1.2% and 0.5% for corticosteroids and moisturizers/emollients during this timeframe.

The full report can be found at www.researchandmarkets. com/research/33sj8d/pharmapoint.

New Products


TWO NEW CERAVE PRODUCTS FROM VALEANT

Valeant Pharmaceuticals North America LLC introduced two new CeraVe Skincare products—CeraVe Eye Repair Cream and CeraVe Intensive Stretch Marks Cream. CeraVe Eye Repair Cream combines three essential ceramides to help repair and restore the delicate barrier around the eyes, with hydrating hyaluronic acid to help diminish fine lines and wrinkles. The eye cream is designed to repair and restore the skin barrier and visibly reduce dark circles and puffiness under the eyes. Patented MVE Technology provides controlled release of ingredients over 24 hours, so eyes look brighter, smoother and healthier all day long. CeraVe Intensive Stretch Marks Cream hydrates and nourishes skin for up to 24 hours while reducing the appearance of stretch marks. Combined with a peptide and botanical complex, essential ceramides help to repair and restore the protective skin barrier, reducing the appearance of unattractive stretch marks. At the same time, hyaluronic acid attracts needed moisture to keep skin soft and supple and argan oil nourishes to help prevent new stretch marks from forming. Both products are fragrance-free, hypoallergenic, and paraben, sulfate and phthalate-free. www.cerave.com.

THERADOME LASER THERAPY HELMET LAUNCHES

The new Theradome Laser Helmet LH80 PRO is the first over-the-counter, FDA-cleared, wearable laser hair restoration treatment. It was developed for in-home use and is clinically tested and designed for patients with thinning hair and androgenetic alopecia. Theradome Laser Helmet LH80 PRO is a compact, cordless, easy-to-use, OTC helmet that uses proven laser light therapy to grow new healthy hair, while doubling the hair follicle size of existing hair and slowing down or stopping hair loss. Using 80 lasers that provide more than 560 mW of low laser light therapy, the helmet stimulates the scalp and hair follicles in a state of decline by increasing blood flow and microcirculation, improving cellular metabolism and protein synthesis to restore and maintain a healthy head of hair. The Theradome Laser Helmet LH80 PRO maximizes human hair growth when used twice a week for 20 minutes per session. www.theradome.com.

SKINCEUTICALS LAUNCHES RESVERATROL B E

Skinceuticals introduced Resveratrol B E, an antioxidant night concentrate. Resveratrol B E features a maximized concentration of 1% pure soluble resveratrol synergistically enhanced with baicalin and vitamin E. To overcome the challenge of formulating a meaningful concentration of resveratrol proven to penetrate skin, Skinceuticals has developed a patent pending delivery system to solubilize a high concentration of resveratrol in an aqueous formulation. In a trial of 55 women with mild to moderate hyperpigmentation, skin laxity, and lines and wrinkles, after 12 weeks of use, Resveratrol B E significantly improved skin radiance, firmness, thickness, elasticity, density, and smoothness. Ultrasound measurement of the effects of Resveratrol B E within the skin showed that after 12 weeks of use, underlying skin repair prompted an 18.9% increase in skin density. www. skinceuticals.com.

DERMABLEND LAUNCHES INTENSE POWDER CAMO

Adding to the company's offerings of crème and liquid foundations, Dermablend offers a new full coverage powder foundation with the new Intense Powder Camo. According to Dermablend, the new foundation effectively covers redness, rosacea, uneven skin tone, acne, acne scars, and birthmarks. The powder contains ultra-soft micro-cushions that provide a soft finish you can see and feel. It lasts all day, is smudge-resistant, water-resistant, and transfer resistant. The powder controls shine and absorbs oil and is offered in a range of 10 true-to-tone shades plus five darker shades that will launch this year. www. dermablend.com.

JF AESTHETIC SKINCARE EXPANDS PRODUCT LINE

JF Aesthetic Skincare, the proprietary line of The Few Institute (TFI), announced the re-launch of its line with new packaging. Formulated with the same powerful, medical-grade ingredients that created a loyal following, JF Aesthetic has an updated look and three new products. The new product launches include: Daily Anti-Oxidant Eye Cream—which calms the skin and helps to mask fine lines; MD Scrub—a scrub that delivers a wave of heat as it removes dry, dead skin cells, excess oils and residue; and Body—a fast-absorbing moisturizer that helps restore and maintain a healthy skin barrier function while preventing water loss. www.drfewbeauty.com

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