Main Issue August 2011

Recent Developments

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Research Updates and News

Corticosteroid Phobia is Prevalent

Topical corticosteroid phobia may be surprisingly prevalent among patients and may even contribute to therapeutic non-adherence, a new study shows. Surveys of 87 adult patients and 144 parents of pediatric patients show that up to 87 percent of patients are fearful of topical corticosteroid use. More than one-third (36 percent) say fears of topical corticosteroids have led them to be non-adherent. Topical corticosteroid phobia did not correlate with atopic dermatitis severity. However, phobia did correlate with need for reassurance, the belief that topical corticosteroids pass through the skin into the bloodstream, a prior adverse event, inconsistent information about the quantity of cream to apply, a desire to self-treat for the shortest time possible, and poor treatment adherence.

The 69-item survey administered to subjects was developed based on interviews with 21 patients and 15 health professionals. Surveys were administered to consecutive patients of 53 private practice dermatologists or at the outpatient dermatology departments of five regional university hospitals. Findings appear in British Journal of Dermatology.

Neurotrophins Linked to Chronic Urticaria

Could neurotrophins play a role in the pathophysiology of chronic spontaneous urticaria? Results of a study appearing in Clinical & Experimental Allergy suggest that they may.

For the study, researchers performed autologous serum skin tests in 50 adult patients with chronic spontaneous urticaria. They also analyzed BDNF serum levels by enzyme immunoassay in the 50 urticaria patients and 23 subjects with healthy skin. Additionally, they took skin biopsies from weals of eight of the patients with chronic spontaneous urticaria as well as from healthy skin of eight of the controls to evaluate the expression of BDNF and its receptors including tyrosine kinase (trk) B and panneurotrophin receptor p75NTR. For inclusion, chronic spontaneous urticaria was defined as recurrent weals for more than six weeks.

While BDNF serum levels were detectable in all subjects, these levels were significantly higher in patients with chronic spontaneous urticaria compared to non-atopic skin-healthy controls. Epidermal and dermal expression of BDNF and epidermal expression of p75NTR was significantly higher in patients with chronic spontaneous urticaria compared with controls. There was no difference with regard to the expression of trkB between the two groups.

Sun and Psoriasis

Coming out of Greece, a recent study in the Journal of the European Academy of Dermatology & Venereology has investigated patterns of presentation of childhood psoriasis in sunny countries and found plaques on the limbs are prevalent. The study looked at a total of 125 children with psoriasis whose peak onset was in the nine to 10-year-old age group and found that plaque type psoriasis was the most prevalent type of presentation with 56.8 percent of the children affected, followed by 33.6 percent experiencing scalp involvement. Limbs were the most common site of involvement, affecting 56 percent of children, followed by the body (47.2 percent) and scalp (48 percent). Most had less than five percent of their skin affected. Age of onset played no factor in the severity of disease and family history didn’t influence the presentation age. However, a positive correlation was found with sex and severity, with males more severely affected (P = 0.0008).

Not A Lousy Option

New data from the recent Annual Meeting of the Society for Pediatric Dermatology suggests that a 0.5% ivermectin (IVM) cream formulation (Topaz) may be an effective agent in the treatment of permethrin- resistant head lice. In the study, permethrinresistant head lice were allowed to lay eggs in tufts of human hair. Adult lice were removed and the tufts with eggs were exposed to 0.5% ivermectin cream, vehicle only, or unformulated, diluted ivermectin. After a 10-minute exposure, tufts were thoroughly rinsed and incubated, while any hatched lice were placed onto new tufts and moved to a feeding cup. The number of hatched lice from eggs exposed to 0.5% ivermectin cream that took a blood meal was decreased by 82-95 percent, relative to eggs exposed to placebo. The researchers also noted that the hatchability of treated eggs was not affected by ivermectin.

Peels Aid Acne

Superficial chemical peels appear to be a worthwhile adjunct in the treatment of acne, a review of the literature concludes. However, the analysis in the June edition of the Journal of the European Academy of Dermatology & Venereology notes that the use of peels as monotherapy for acne has not been fully investigated.

The paper reviewed the literature on the use of chemical peeling to treat acne. Thirteen trials were reported, most of which evaluated small numbers of patients. These studies, mainly open label, were not placebo-controlled. Nonetheless, these studies all showed generally favorable results and suggested that chemical peeling provides benefits in the management of acne vulgaris. It is unclear how many of the studies evaluated the effect of peeling as monotherapy. However, the authors note that use of peels as the only treatment for acne is an unlikely regimen, “except in rare instances where a patient could not tolerate other treatment modalities.” They urge further study to define the best use of chemical peels in active acne care.

Tanning Tax Controversy Emerging

A panel of 25 Congressional Representatives has proposed legislation (H.R. 2092) to repeal the tanning tax. The legislators say the tax is a burden on small business owners and hurts the economy. Opponents of repeal say that elimination of the tax could risk public health. The tanning tax, implemented as part of healthcare reform efforts, was introduced in place of an originally proposed cosmetic surgery tax. Many public health officials and dermatologists hailed the tanning tax on the assumption that it would dissuade tanning, especially among teens and young adults. The American Academy of Dermatology Association (AADA) and the Dermatology Nurses' Association (DNA) are among groups publicly opposed to tan tax repeal.

Emollient Foam Wins Over Patients with AD

A non-steroidal, ceramide-hyaluronic acid emollient foam may provide better results than a topical calcineurin inhibitor for the management of atopic dermatitis, results of a 30-patient, open-label, investigator-blinded, bilateral comparison study show (J Drugs Dermatol, E-pub June). Patients treated with Hylatopic Plus (Onset Dermatologics) had a 67.9 percent overall improvement in IGA scores, compared to 63.1 percent improvement with pimecrolimus cream 1%. At the conclusion of the study, 82 percent of foam-treated patients were clear or almost clear, compared to 71 percent of creamtreated patients. Sixty-eight percent of patients reported that they preferred the foam formulation over the cream.

Product News

Avene’s new TriAcneal combats acne breakouts and minimizes the appearance of lines and wrinkles with little or no irritation, the company says. TriAcneal is formulated with Efectiose, a bio-available ingredient to treat inflammation, scarring, and excessive cell build-up associated with acne, the company says. It also contains retinaldehyde, to stimulate elastin and collagen synthesis, and glycolic acid, to exfoliate and cleanse the skin. In a six-week trial, 27 percent of participants reported a rapid decrease of retentional acne lesions after 15 days of use, and 42 percent of participants reported a long-lasting reduction of inflammatory acne lesions after six weeks of use, according to Avene. TriAcneal will be available in September 2011.

New Barrier Ointment Available

Replenix ResurFIX Skin Barrier Healing Ointment, an all-in-one recovery formula said to cool, soothe, and restore skin post-procedure is now available from Topix Pharmaceuticals. Containing Ceramides 2 and 3, green tea extract, vitamin E, allantoin, and other ingredients, ResurFIX cosmetically improves the appearance of scar tissue and creates an effective skin barrier that allows for the texture renewal of stressed skin, the company says.

Aloe Kit for Acne

A new aloe-based acne kit may provide relief for patients. The Lexli Acne Treatment Kit includes an aloe-based Acne Cleanser, which is designed to remove excess oil; AloeGlyC,a daily exfoliant that features an effective pH near that of a chemical peel; Acne Clarifying Lotion; and Acne Moisturizer with Sunblock, which is designed to moisturize and protect acne-prone skin from increased sun sensitivity (due to the use of AloeGlyC) while reducing inflammation. Lexli skin care also has redesigned its website, with stronger educational content and tips for healthy skin and an improved professional support area.

New Topical Corticosteroid Formulation Launched

A new prescription topical corticosteroid product is available that, according to its maker Upsher- Smith, offers the feel of a cream with the strength of an ointment. Trianex 0.05% (triamcinolone acetonide ointment) combines triamcinolone with a cream-like base to relieve inflammation and itching. Trianex is formulated with a proprietary hydrous emulsified base that helps maintain moisture to soften and smooth the skin. It also provides ointment occlusivity to help enhance corticosteroid absorption, and it does not contain preservatives, according to the company. Trianex 0.05% is supplied in 17g tubes and 85g tubes.

Scar Cream for Kids

Mustela’s Stelatria Purifying Recovery Cream is a new product for scarring in pediatric patients. The complex of copper, zinc, and manganese stimulates epidermal regeneration and restores barrier function in skin that has been compromised by irritation, allergies, or minor cuts and scrapes, the company says. Made for newborns, infants, toddlers, and adults alike, Stelatria Purifying Recovery Cream also contains the natural active ingredient BioEcolia, which bolsters skin’s own protective flora to further support recovery, according to Mustela. The product will be available in September.

Popular European Line Arrives in US

A mild, pH-balanced skin care line that the company says nurtures children’s skin from birth to adolescence, is now available in the US. Baby Sebamed products offer hypoallergenic, soap-free skin protection for newborns and children of all ages. The line includes Baby Sebamed Children’s Shampoo, Baby Sebamed Baby Wash, Baby Sebamed Baby Cream, and Baby Sebamed Baby Bubble Bath. A general use line is also available for treating sensitive, oily, and dry skin and is formulated to not irritate or compromise skin that is being treated for diseases including eczema, acne, rosacea or psoriasis.

Conventional Wisdom

Set Expectations in Acne Care. Establish realistic expectations among acne patients, urged acne specialist Diane Thiboutot, MD at the Summer Meeting of the Society of Dermatology Physician Assistants. While clinicians know that available acne therapies are actually acne preventives, patients do not, and they may anticipate very rapid results. Early therapeutic benefit may be seen by about four weeks, but based on the pathogenesis of acne, patients really must remain on therapy for six to eight weeks to appreciate notable improvement, she said.

Participate in Adverse Event Reporting. Clinicians should increase their reporting to MedWatch to improve pharmacovigilance. Under-reporting of adverse events remains a major problem in drug safety research, said dermatologist and researcher Joel Gelfand, MD at the Summer Meeting of the Society of Dermatology Physician Assistants. According to Dr. Gelfand, identification of new and emerging adverse events often relies on epidemiological studies, which must be viewed carefully. One common shortcoming of current safety analyses may be the finding that “Reported rates [of adverse events] are lower than would be expected.” Such a statement ignores the influence of non-reporting.

FDA Unveils Long-awaited Changes to Sunscreen Labels

FDA announced a series of actions that will change sunscreen labeling within the year—probably before next summer for many products. The changes, intended to help consumers better understand the type and level of protection sunscreens afford, may create some confusion for patients familiar with old labeling. Physicians may have mixed reactions to the contents of the new Final Rule, a Proposed Rule, an Advance Notice of Proposed Rulemaking, and a Draft Guidance for Industry, all of which are posted at Guidelines on UVA scoring are still to be addressed in future actions.

FDA Summarizes key features of the Final Rule, as follows:

Broad Spectrum designation. Sunscreens that pass FDA's broad spectrum test procedure, which measures a product's UVA protection relative to its UVB protection, may be labeled as "Broad Spectrum SPF [value]" on the front label. For Broad Spectrum sunscreens, SPF values also indicate the amount or magnitude of overall protection. Broad Spectrum SPF products with SPF values higher than 15 provide greater protection and may claim additional uses, as described in the next bullet.

Use claims. Only Broad Spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Non- Broad Spectrum sunscreens and Broad Spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn. They will bear a warning: “Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

"Waterproof,” "sweatproof," or "sunblock" claims. Manufacturers cannot label sunscreens as "waterproof" or "sweatproof," or identify their products as "sunblocks," because these claims overstate their effectiveness. Sunscreens also cannot claim to provide sun protection for more than two hours without reapplication or to provide protection immediately after application (for example, "instant protection") without submitting data to support these claims and obtaining FDA approval.

Water resistance claims. Water resistance claims on the front label must indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water resistant sunscreen if swimming or sweating.

Drug Facts. All sunscreens must include standard "Drug Facts" information on the back and/or side of the container.

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