Main Issue June 2011

Recent Developments: Research Update

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Topical Anti-Androgen Shows Promise for Acne

Topical anti-androgen therapy for acne vulgaris could be moving closer to clinical reality. The investigational topical agent Cortexolone 17 alpha-propionate or CB-03-01 offers greater efficacy than vehicle, new data show. The study appearing early online in the British Journal of Dermatology involved 77 adult men with facial acne scoring 2 to 3 on the Investigator’s Global Assessment or IGA. They were randomly assigned in a roughly 2:2:1 fashion to treatment with Cortexolone 17 alpha-propionate 1% cream, tretinoin 0.05% cream, or placebo cream once a day at bed-time for eight weeks.

Efficacy measures, including total lesion count, inflammatory lesion count, acne severity index, and IGA, were assessed every two weeks. CB-03- 01 provided a rapid improvement in acne severity; Subjects treated with CB-03-01 attained 50 percent or better improvement in all efficacy parameters more quickly than patients in the other arms. The topical anti-androgen produced significantly greater improvements in total and inflammatory lesion counts and acne severity index scores compared to placebo. At the end of the study period, there were trends toward improved clinical outcomes compared to tretinoin, but they were not statistically significant.

New Lice Therapy Approved

Natroba Topical Suspension 0.9% (spinosad, ParaPro) recently received FDA approval for the treatment of head lice infestations in patients ages four years and older. In two multicenter, randomized, active-controlled studies, a total of 552 subjects received a 10-minute treatment with Natroba. If live lice were seen a week later, a second treatment was applied. The proportion of subjects who were lice-free 14 days after the final treatment was approximately 86 percent, compared to 44 percent of the control group. Common adverse events reported include redness or irritation of the eyes and skin. Safety in pediatric patients below the age of four years has not been established, and the product must not be used in infants because it contains benzyl alcohol, associated with serious adverse reactions, including death, when applied topically to the skin of children younger than six months.

New Marketer for Corticosteroid

Promius Pharma has signed an agreement to market the topical steroid Cloderm (clocortolone pivalate 0.1%) Cream and will begin distribution and marketing in the US effective immediately. Cloderm is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses and is available in a 45g or 90g tube, as well as in a 30g or 75g pump.

Insights on IgE Sensitization in AD

Serum interleukin-16 levels of atopic dermatitis patients correlate with sensitization but not as strongly as total IgE levels correlate with allergic sensitization, a recent analysis shows. The immunomodulatory cytokine IL-16 amplifies inflammatory processes, possesses immunoregulatory functions, and is chemotactic. To determine its association with sensitization in atopic dermatitis, researchers assessed eosinophil cell count, serum total and specific IgE levels, and carried out prick tests in patients with atopic dermatitis or psoriasis and healthy volunteers.

Based on specific IgE levels and prick tests, atopic dermatitis patients were divided into sensitized and nonsensitized subgroups, and correlations among serum IL-16, total IgE levels and eosinophil cell counts were measured in the total patient group and in subgroups.

Patients with atopic dermatitis had significantly higher levels of IL-16, compared to healthy individuals and patients with psoriasis. Serum levels of IL-16 May/June 2011 | Practical Dermatology for Pediatrics | 7 were significantly correlated with total IgE and total IgE was significantly correlated with eosinophil counts, but there was no correlation between IL-16 and eosinophils.

When sensitized and nonsensitized subgroups were compared, there was a significant difference in IL-16 levels in subgroups that were divided based on specific IgE measurements, but not in those subgroups divided based on prick tests. Serum total IgE levels were significantly different between sensitized and nonsensitized subgroups, assessed by the specific IgE method and also by prick test. Findings appear online in International Journal of Allergy and Immunology.

Findings on Corticosteroid Allergy

New insights into corticosteroid allergy come from a large study of 3,594 Danish subjects (Contact Dermatitis). Subjects were patch tested with tixocortol- 21-pivalate, budesonide, and hydrocortisone-17- butyrate.

Two percent of the total tested population had a steroid allergy. Of these, 0.8% had a tixocortol- 21-pivalate allergy and 1% each had a budesonide or hydrocortisone-17-butyrate allergy. Although crude analysis suggested an association of Tixocortol-21- pivalate and budesonide allergy with atopic dermatitis, only tixocortol-21-pivalate allergy and atopic dermatitis remained associated after adjusted analyses. Leg dermatitis was uniquely associated with tixocortol- 21-pivalate allergy. In both crude and adjusted analyses, Hydrocortisone-17-butyrate allergy was associated with duration of disease.

Researchers speculate that, due to ease of access, more pronounced exposure to group A steroids accounts for the higher risk of allergy to these steroids in patients with leg dermatitis or AD. The duration of disease rather than the dermatosis itself seemed to be important for group B and D2 corticosteroid allergy.

Obesity Linked to Atopic Dermatitis

Obese children may be at a higher risk to develop atopic dermatitis, according to a study published in Journal of Allergy and Clinical Immunology. Following 414 children and adolescents (aged 1-21 years) with atopic dermatitis between January 2000 and December 2007 and 828 randomly sampled healthy controls, the authors found that kids who became obese between ages two and five had more than three times the risk of developing AD. Researchers also found that the skin condition was more severe than normal when it occurred in obese children.

NB-UVB Affirmed

More data confirm the safety and efficacy of NB-UVb for psoriasis and atopic dermatitis in children (J Eur Acad Dermatol Venerol 25(6):727-29). In the retrospective analysis of 129 patients, phototherapy yeilded complete clearance in 50 percent of psoriasis patients and 25 percent of those with AD. Therapy was welltolerated with no serious adverse events except one doubtful melanoma in situ.

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