HAIR AND NAIL DISORDERS

P6100A comparison among commonly used nail products on nail mechanicalproperties

Federico Mailland, MD, Polichem SA, Lugano, Switzerland; Maurizio Caserini,MD, Polichem SA, Lugano, Switzerland; Mauro Catena, Polichem SA, Lugano,Switzerland; Michele Setaro, Tecnolab del Lago Maggiore S.r.l., Verbania, Italy;Renata Palmieri, PharmD, Polichem SA, Lugano, Switzerland

The performance of a new medical device, containing hydroxypropil-chitosan(HPCH), horsetail extract (E arvense) and methylsulphonyl-methane (MSM) onnail mechanical properties, including hardness, tensile strength and ultrastruc-ture was assessed in comparison to the application of solvents or moisturizerscommonly used in the management of nail disorders. The tests were performedon bovine hoof slices. Samples were polished with grit and cleaned with acloth. Three products were tested: the medical device based on hydroxypropil-chitosan (P1), a urea 40% water solution (P2) and a isopropyl alcohol 70% watersolution (P3). They were uniformly applied on the hooves and the samplesstored at 20 6 28C and 50 6 2% RH for 24 hours. The samples were washed,dried and then the application was repeated. Treated and control (untreated)samples were stored at controlled temperature and humidity until the perfor-mance of the mechanical tests. The ultrastructure was assessed before/afterabrasion and using the index of crumbling (difference between mean percentarea after and before the abrasion). Twenty replicates were made per test andper product. The bovine hooves treated with P1 result harder and moreresistant to tensile strength in comparison to P2, P3 (P \ .001) and to controlsamples (P \ .001 - hardness, P \ .05 - tensile strength), being hardness meanvalues 22.27 6 2.01 vs 17.98 6 1.39 (P2), 17.59 6 1.22 (P3) and 19.36 6 1.23(control) and tensile strength mean values 33.07 6 5.46 vs. 25.03 6 4.02 (P2),23.41 6 7.48 (P3) and 28.42 6 5.39 (control). Moreover, nails were less hardand more brittle after treatment with P2 and P3 in comparison to the controlgroup (P \ .001 for hardness P \ .05 for tensile strength). The index ofcrumbling was significantly higher (P \ .001) for the control group incomparison to the other groups being the mean value 17,843.35 6 3196.24vs. 7418 6 1094.29 (P1), 8126.7 6 1960.8 (P2) and 8011 6 1399.94 (P3). Inconclusion the experiments show that some commonly used tools seriouslydamage the nail structure, leading to nail dystrophy. On the contrary, the HPCHbased medical device improves nail integrity protecting by physical damageand/or chemical aggression.

APRIL 20

ponsored by Polichem S.A.

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P6913A nodule in the toe: Case report of eccrine poroma

Hind Haim, Dermatology Venerology Department, UHC Ibn Rochd, Casablanca,Morocco; Hakima Benchikhi, Dermatology Venerology Department, UHC IbnRochd, Casablanca, Morocco; Soumiya Chiheb, Dermatology VenerologyDepartment, UHC Ibn Rochd, Casablanca, Morocco

Background: Eccrine poroma (EP) is a benign tumor which arises from theintraepidermal portion of the eccrine sweat glands. We report a rare case ofbenign EP in the external side of big toe of a young lady mimic vascularmalformation.

Case report: A 30-year-old lady presented with a 4 years history of a slightly reddishnodule gradually growing in her left big toe witch was painful. She blames thispainless lesion for an injury. Physical examination revealed a fixed sessile mass in thesubcutaneous plane of the toe measuring 1.8 3 1.3 cm, soft, well circumscribed,nonulcerated, nontender, and without pulsation. There were no associated neuro-logic or vascular symptoms. X-ray of left foot was unremarkable but a Doppler of thelesion showed vascular malformation. Clinically an implantation dermoid cyst or anadnexal tumor was suspected and a wide excision of skin and subcutaneous tissuewas done. On incision we got a little mucoid fluid. Excisional biopsy revealedEccrine Poroma. The patient was remained well with no evidence of recurrenceafter 10 months of follow-up.

Discussion: We describe an unusual clinical variant case of benign EP because of thelocalization and the appearance of the tumor mimic of vascular malformation andpatient’s age. By reporting this case we recommend that the diagnosis of EPsuspected clinically should always be confirmed histologically as the differentialdiagnosis includes amelanotic melanoma as well as the less serious diseases such aspyogenic granuloma.

cial support: None identified.

Commer

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P6514A phase II study of efinaconazole solution for the once-daily treatment oftoenail onychomycosis: Primary efficacy assessment

Eduardo Tschen, MD, Academic Dermatology Associates, Albuquerque, NM,United States; Hideki Kawabata, MS, Kaken Pharmaceutical Co Ltd, Tokyo,Japan; Jason Olin, PhD, Valeant Pharmaceuticals North America LLC,Bridgewater, NJ, United States; Radhakrishnan Pillai, PhD, Dow PharmaceuticalSciences (a division of Valeant Pharmaceuticals International), Petaluma, CA,United States

Background: Onychomycosis is a common fungal infection of the nail. It mayresult in nail dystrophy and may have a significant impact on quality of life. Oraltreatment is generally required but use may be limited by drugedrug interactionsand other safety concerns. Efficacy rates of topical treatments have beendisappointing.

Objective: (1)To evaluate the safety and efficacy of two strengths of efinaconazolesolution (5%, 10%) versus vehicle in mild to moderate onychomycosis of thetoenails; (2) to establish efficacy and provide information to design phase IIIstudies.

Methods: A multicenter (Mexico sites), randomized, double-blind study in 135subjects. Subjects (aged 18-65) received efinaconazole 10% solution (with orwithout semi-occlusion), efinaconazole 5% solution or vehicle once daily for36 weeks, with 30-day post-treatment follow-up (Study DSP-IDP-108-P2-01).Complete cure (0% clinical involvement of the target toenail in addition to anegative KOH examination and fungal culture of the target toenail sample)was assessed at week 24 and 36 and posttreatment follow-up. Clinicalefficacy (an affected target toenail area of \20%) and mycologic cure(negative outcome in both KOH test and fungal culture of the target toenail)were assessed throughout the study and at the 30-day posttreatment follow-up visit.

Results: At week 40, all evaluated efficacy criteria were numerically better for theactive arms compared to vehicle. The rate of complete cure rate was 22.2% withefinaconazole 10% solution (semi-occlusion) compared to 25.6% with efinaconazole10% solution (no occlusion), 15.8% with efinaconazole 5% solution and 9.1% withvehicle. Clinical efficacy was 66.7%, 69.2%, 57.9% and 31.8% respectively (P¼.0088and .0064 for the two efinaconazole 10% solution groups versus vehicle). Themajority of subjects in each active treatment group had mycologic cures from week24. Mycologic cure rates at week 40 were 83.3%, 87.2%, 86.8%, and 72.7%respectively.

Conclusion: When applied once daily for 36 weeks, all active arms were moreeffective than vehicle. Efinaconazole 10% solution (with or without semiocclusion)was more effective than efinaconazole 5% solution in treating mild to moderatetoenail onychomycosis.

sponsored by Valeant Dermatology a division ofeuticals North America LLC.

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J AM ACAD DERMATOL AB101