New Products Therapeutics Focus: Sports Dermatoses
Vitiligo Camouflage Applicator
Zanderm released its flagship product, the Zanderm Vitiligo Camouflage Applicator. Most people with vitiligo turn to cosmetics to compensate for the loss of color, but many of these cosmetics are vulnerable to both water and sweat. Zanderm offers a time-saving solution which dries fast, and resists both sweat and water. Some users can keep Zanderm’s coloration in place for up to seven days with only a few light touch-ups. It’s suitable for all skin types and won’t rub away, get on clothing, or draw attention to itself. The company is also working on a larger applicator next. Zanderm currently offers 11 unique colors suitable for a range of shades. Zanderm.com
TriCalm Expands Itch-Relief Product Line
Cosmederm Bioscience, Inc. expanded of its itch-relief product line, TriCalm, with the new TriCalm Clinical Repair Cream and TriCalm Extra Strength Spray. In addition to TriCalm Hydrogel, these two new offerings strategically expand the brand’s line of steroid-free, anti-itch products to further benefit sufferers of itch. Clinical Repair Cream is ideal for those suffering from dry, itchy skin, while Extra Strength Spray is formulated for use on contagious or hard-to-reach areas, such as rashes from poison oak or ivy. Like Hydrogel, the new TriCalm Clinical Repair Cream and TriCalm Extra Strength Spray have been awarded the National Eczema Association Seal of Acceptance. TriCalm.com
Suneva Medical Launches Regenica Revitalizing Eye Crème
Suneva Medical, Inc. introduced Regenica Revitalizing Eye Crème, an eye crème developed with the combination of MRCx next generation growth factor technology, advanced peptides, powerful antioxidants, and moisturizing agents. Regenica Revitalizing Eye Crème is specifically formulated for the delicate skin around the eye and is clinically proven to decrease the appearance of lines and wrinkles in the crow’s feet and under eye areas. The crème is the latest addition to the Regenica skincare line, a family of next generation anti-aging products that help prevent and reverse signs of aging. Regenica.com
Replenix Pure Hydration Hyaluronic Acid Serum from Topix
Topix Pharmaceuticals, Inc. introduced Replenix Pure Hydration Hyaluronic Acid Serum, a nourishing serum that quenches dehydrated skin to impart a supple, smooth complexion and instant correction, visibly reducing the signs of aging. Formulated with various molecular forms of hyaluronic acid that penetrate and protect the skin, this therapeutic serum provides maximum hydration.
Delivering the best plumping result without a needle, Replenix Pure Hydration Hyaluronic Acid Serum can be used alone or as a universal booster with any skin care product and regimen. Adding just a drop of this advanced formula ensures maximum moisture retention. Topixpharm.com
Therapeutics Focus: Sports Dermatoses
Azole Resistance in Dermatophytes
Azole antifungal agents such as fluconazole and ketoconazole have been widely used to treat superficial fungal infections caused by dermatophytes, and, unlike the allylamines (such as terbinafine and naftifine), have been associated with resistance development. Although a considerable number of published manuscripts describe resistance to azoles among yeast and molds, researchers noted that reports describing resistance of dermatophytes are starting to appear. A review was conducted to discuss the mode of actions of azole antifungals and mechanisms underlying their resistance as compared with the allylamine class of compounds. Data from published and original studies were compared, summarized, and their clinical implications discussed. The results, presented in a poster at the Annual Meeting of the AAD that was supported by Merz North America, Inc. The incidence of azole resistance in dermatophytes is reported to be as high as 19 percent among the worldwide population. In contrast to the cidal allylamines, static drugs such as azoles inhibit the growth of the organism, permitting occurrence of mutations in enzymes involved in ergosterol biosynthesis, which serves as the drug target. Additionally, unlike allylamines, the ergosterol precursors accumulating as a consequence of azole action are not toxic. Researchers concluded azole antifungals, unlike allylamines, potentiate resistance development in dermatophytes.
— Ghannoum M. Azole Resistance in Dermatophytes: Prevalence and Mechanism of Action. Poster
An Open-Label, Multi-Center, Multiple Application Study in Pediatric Subjects with Athlete’s foot
Clinical data on topical antifungal therapy using naftifine for tinea pedis in a pediatric population is limited. A recent study was conducted to assess trends in efficacy, tolerability, and safety, and to quantify the pharmacokinetics profile of topical naftifine hydrochloride gel 2% in pediatric subjects aged 12 to 17 years, 11 months with tinea pedis under maximal clinical use conditions (both feet affected). An open-label, multicenter, multiple-application study using once daily application of naftifine hydrochloride gel 2% for two weeks in a pediatric population with tinea pedis. A total of 22 pediatric subjects were enrolled and received naftifine hydrochloride gel 2% and 21 subjects (96 percent) were considered PK evaluable (defined as having all PK data available to complete the analysis). Safety/tolerability and trends in efficacy were assessed in all 22 pediatric subjects enrolled.
For this study, subjects applied an expected amount of 4 grams (2 grams per foot) of naftifine hydrochloride gel 2% once daily in the morning for 14 days. All doses at in-clinic study visits (days 1, 2, 7, 12, 13 and 14) were applied while the subject was on-site and all other doses were applied at home. Subjects remained at the clinic for 24 hours on Days One and 14 to collect blood and urine samples for PK analysis.
The results, presented in a poster at the 2015 Annual Meeting of the American Academy of Dermatology and supported by Merz, showed naftifine hydrochloride gel 2% was efficacious for tinea pedis in pediatric subjects. The researchers found that while positive results were observed as early as Day Seven for some efficacy measures, the proportion of subjects achieving each efficacy endpoint generally increased over time through Day 28 (2 weeks post-treatment).
Two out of 22 (9.1 percent) pediatric subjects experienced treatment emergent adverse events (TEAEs) during the study. None of the TEAEs were a serious adverse events or led to dose reduction or discontinuation from the study. Overall, Naftifine hydrochloride gel 2% was found to be well tolerated and safe in a pediatric population. The PK results indicated that the rate and extent of systemic exposure is low.
—Verma A, Olayinka B, Fleischer AB. Clinical Benefit and Assessment of Pharmacokinetic Profile of Naftifine Hydrochloride Gel 2%: An Open-Label, Multi-Center, Multiple Application Study in Pediatric Subjects with Tinea Pedis. Poster ID 1283.
Jublia is Now Available in 8mL Size
JUBLIA (efinaconazole) topical solution 10% is indicated for the topical treatment of onychomycosis (tinea unguium) of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes. It is now available in an 8mL size. There is also a coupon available for patients for a $0 co-pay. For more information, visit https://www.activatethecard.com/7143/home.html#Again-no-back-button. n
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