Nuvail™ 2014 Press Kit

Reveal Strong & Healthy Nails

Rx Only Nuvail™ (poly-ureaurethane, 16%) NAIL SOLUTION

#1 Prescribed Brand in Dermatology & Podiatry for Nail Dystrophy

Important Safety Information: Rx Only May temporarily sting upon application. Persons sensitized to isocyanate should™ not use this product. Should redness or other signs of irritation appear, discontinue use and consult your healthcare provider. View full Prescribing Information at http://nuvail-rx.comNuvail or by scanning the QR code: (poly-ureaurethane, 16%) FDA approved for managing signs and symptoms of nail dystrophy. NAIL SOLUTION Innocutis is excited to announce that NUVAIL™ is currently the #1 prescribed brand for nail dystrophy in Dermatology and Podiatry. Nuvail has been receiving national recognition in the following publications and media outlets:

O The Oprah Magazine

Published at the APMA

CLINICAL EVALUATION OF A TOPICAL POLY UREA-URETHANE 16% POLYMER ON DYSTROPHIC NAILS: A REVIEW Greg Santamaria, BS* • Tracey Vlahovic, DPM** Temple University School of Podiatric Medicine - Philadelphia, PA • *Fourth year student • **Associate Professor

INTRODUCTION MATERIALS & METHODS RESULTS CONCLUSION Fifty three (53) subjects completed the Onychodystrophy, which is any alteration of nail staining and fungal culture can aid in determining 6 month period of treatment with the Overall, treatment of nail dystrophy should investigational product. Of the AEs as- morphology, describes a wide spectrum of nail the presence of a dermatophyte-caused infection. The efficacy and safety of po- be maintained, with clean and months. Trichophyton rubrum Table 1: Subject Baseline Characteristic Summary first involve elucidating the cause: infec- disorders caused by either exogenous or endog- sessed during the trial, there were 4 There are several types of that one ly-ureaurethane, 16% was re- debrided nails. They were in- was the most commonly cul- Age 24 to 65 years; average 51 years subjects who related stinging, burning, tion, an inflammatory skin disorder, or bio- enous insults. Nail dystrophy may manifest as a can differentiate by the initial site of involvement ported in a study by Nasir et structed to allow the prod- tured organism at baseline. In Gender Male [50] Female [13] or irritation of the treatment site. This mechanical trauma. When dealing with a misshapen, damaged, infected, or discolored nail Percent Nail Involvement [#] 0-19% [0] 20-35% [11] 36-50% [30] 51-65% [22] and pathophysiology. The most common type is al in the Journal of Drugs and uct to dry thoroughly before addition to fungal scrapings rate of anticipated AEs is similar when dystrophic nail caused by dermatophyte unit that may affect the fingernails, toenails, or distal (or distal lateral) subungual onychomyco- Dermatology.4 This was a pro- donning socks or any other performed at each visit, any Positive KOH & Positive Culture [#, %] 63 [100%] compared to the AEs noted during the both. Morphologic terms commonly used to de- sis.2 It presents as with discoloration, spective, self-controlled, and garment. adverse events (AEs) and visual Dermatophyte cultured [#] Trichophyton sp [62] Epidermophyton sp. [1] topical ciclopirox trials. From a myco- infection, a fungal culture/mycological Nail thickness [#] ≤1 mm [1] 1-2 mm [14] 2-3 mm [48] ≥3 mm [0] logical perspective, after one month scribe these affected nails are onycholysis, onych- subungual debris and hyperkeratosis. Concurrent single arm study of adult pa- assessment of the treated tar- staining should be obtained prior to treat- auxis, and . Onycholysis is separa- Establishment of a diagnosis of 2 mm clear nail proximally [#, %] 63 [100%] of treatment, 28% of the patients had tinea pedis is often seen interdigitally or plantarly tients with KOH and culture get toenail were documented. achieved a culture negative status. Sixty ment to concur with the clinical diagnosis tion of the nail plate from the nail bed and may dermatophyte (Trichophyton on the foot. Trichophyton rubrum is the pathogen confirmed onychomycosis Visual assessment parameters Table 2: Change in Visual Assessment Parameters from Baseline to Six-Month Follow-Up Visit two percent (62%) of the 53 subjects be caused by exogenous trauma, but also may be or Epidermophyton species) and, ultimately, treatment should be tai- most associated with this infection. of at least one great toenail. included notation of improve- Nail Subungual were fungal culture negative at the involvement was completed Visual Parameter Color Onycholysis Thickness lored to the nail disorder present. Beyond caused by a systemic disorder like . The Sixty three (63) healthy adults ment, no change, or deterio- Involvement Hyperkeratosis end of the six month treatment period Dermatophyte infection of the nail plate and bed at baseline, and then follow Change from baseline pocket created also creates a pathway for derma- Number [percentage] of total subjects [Figure 1]. Improvement of the visual the standard treatments for fungal is clinically and cosmetically unappealing. Without (aged 18-65) had nails that up KOH and fungal cultures ration of the following: color, to 6 months tophytes to infect the nail bed. Onychauxis is thick- ranged in 20-65% nail involve- nail involvement, onycholysis, assessments were reported as 30% in nails, the newest treatment for fungally- treatment, onychomycosis continues to damage were done at visit labeled 1 Deterioration 7 [13] 6 [11] 5 [9] 2 [4] 8 [15] color, 49% in nail involvement, 38% ening of the nail unit seen both in onychomycosis ment with no lunula involve- thickness, and subungual hy- induced onychodystrophy involves ap- and psoriasis. Onychorrhexis presents as nail plate the nail plate. Treatment for onychomycosis in- month (one month after treat- No change 30 [57] 21 [40] 28 [53] 33 [62] 25 [47] in onycholysis, 34% in nail plate thick- ment [Table 1]. Patients were perkeratosis [Table 2]. ness, and 38% in subungual hyper- ridges parallel to the lateral nail fold. This may be cludes targeting the causative organism with ei- ment began), 3 months, and 6 Improvement 16 [30] 26 [49] 20 [38] 18 [34] 20 [38] plication of a non-drug topical which is excluded from the study if the keratosis. After six months 60% of the seen as a sign of normal aging or as the manifesta- ther oral terbinafine, oral itraconazole in pulsed meant to provide support and protect the doses and singular daily doses, oral fluconazole nail was thicker than 3 mm subjects had overall improvement in tion of underlying diseases such as clinical nail characteristics [Figure 2]. nail from further damage. This product dispensed in once weekly dosages, oral griseoful- or had an uncontrolled medi- and psoriasis. cal condition that would de- Figure 1: Mycology Results. Cumulative Rates Of Dermatophyte-Negative Culture. Figure 3: Clinical effects of poly-ureaurethane, 16%. Progression of subject at base, 3 months, 6 months and One of the subjects from the study is has shown to be efficacious in managing vin, or topical ciclopirox lacquer among many oth- 12 months (6 months after discontinuation of therapy). represented in [Figure 3]. The most common type of nail dystrophy we see er over-the-counter and compounded remedies. crease circulation to the lower the signs and symptoms of nail dystrophy 100% Baseline 3 months using Nuvail Subjects that were dermatophyte neg- as podiatric practitioners is onychomycosis which Mechanical debridement to debulk the nail unit is extremity. 53 Subjects as well as being safe to use. 1 ative at the end of six months [33/53] represents about half of the pathologies seen. also standard to allow topical medications to better The investigational product, 80% 62% were asked to come back for a follow- Other disorders, such as lichen planus, psoriasis, penetrate and create comfort in shoes. Also, clini- poly-ureaurethane, 16%, was 60% up visit at 12 months; no use of the

and trauma can also cause nail dystrophy. Since cians may use topical urea preparations to soften a polymeric suspension that Efficacy 40% 28% 36% product for 6 months. 25/33 came back many nail disorders mimic onychomycosis in clini- 0% and smooth the nail plate and apply a laser such as formed a uniform film when 20% for the follow up visit to have the same nail from the trial sampled again. 6/25 cal presentation, it is imperative for the practitio- the 1064 nm YAG to theoretically create an inhos- applied to the nail. The poly- 0% had a recurrence of onychomycosis in- ner to determine the cause of the nail dystrophy pitable environment for the dermatophyte. Often, mer product was dispersed in Baseline 1- Month fection and 19/25 had no recurrence. References prior to treatment. This poster will focus on nail after these various treatment plans have been uti- organic solvents that vapor- 3-Month 6-Month dystrophy caused by dermatophyte infection. lized, the nail plate still retains its dystrophic ap- ized rapidly upon application Time Point 1. Allevato MAJ. Diseases Mimicking Onychomycosis. Clinics in Dermatology (2010) 28, 164-177. pearance, which frustrates both the patient and Onychomycosis or tinea unguium is caused by which allowed the suspended 2. Vlahovic TC and Schleicher SM. “Nail Disorders” in Skin Disease of the Lower invasion of the nail unit by dermatophytes, non- practitioner and often allows for re-entry of the polymer to adhere to the con- Extremities: A Photographic Guide, HMP Communications, 2012, pp 19-20. dermatophyte molds, and/or Candida albicans. dermatophyte infection. tours of the nail to form a flex- Figure 2: Clinical Assessment. Change in total clinical nail characteristics from baseline to 6-months. 6 months using Nuvail 12 months (6 months after discontinuation of therapy) 3. http://www.prnewswire.com/news-releases/innocutis-announces-the-fda- approval-of-nuvail-poly-ureaurethane-16-for-the-treatment-of-nail-dystro- Onychomycotic nails generally are described as While these treatments have been readily used ible, waterproof barrier over phy-170159816.html onycholytic, discolored, and hyperkeratotic with the nail. The film is colorless, 4. Nasir A, Goldstein B, van Cleff M, and Swick L. Clinical Evaluation of Safety and over the years by clinicians with varying degrees 100% DISCUSSION Efficacy of a New Topical Treatment for Onychomycosis. J Drugs Dermatol. (2011) 10 subungual debris. Clinicians may see concomi- of success, a topical medication that protects the transparent, and possesses (10): 1186-1191. 80% tant tinea pedis or tinea cruris in patients with nail from further insult by a dermatophyte and/or good moisture vapor permea- Limitations of the study include small onychomycosis. the environment and manages the signs of onycho- bility. Subjects in the trial ap- 60% sample size and lack of comparator. plied the product once daily Download a copy of this poster onto your mobile device at the QR code below: The most common form of onychomycosis on the dystrophy would be a welcome addition to the nail 40% The investigational product of poly- toenails is distal lateral subungual onychomycosis treatment armamentarium. Recently, the FDA has to the affected great toenail at ureaurethane, 16% does not contain an bedtime during the week, but 20% caused by Trichophyton rubrum. Clinically, it may approved the use of a topical poly-ureaurethane, percent of subjects 60% 17% 23% active pharmaceutical agent and is not absorbed by the body. The mycological be difficult to distinguish onychomycosis from oth- 16% (Nuvail, Innocutis) for dystrophic nails (i.e. nails had a product holiday over the 0% Supported by: culture results alone are noteworthy for 3 weekend. Nail hygiene had to Improvement No Change Deterioration er existing nail pathologies. KOH prepration, PAS affected by psoriasis, trauma, onychomycosis). this topical agent. Innocutis Holdings, LLC The Dermatologist

Addressing the FrustrAtions oF And disorders

Addressing the FrustrAtions oF A full feature article titled Nail DisorDers “Addressing the Frustrations of Nail Disorders” Many patients who present with nail dystrophy are concerned about the appearance of their nails. authored by Risha Bellomo, MPAS, PA-C RishA Bellomo, mPAs, PA-C

Nuvail™ (poly-ureaurethane, 16%) is a polymeric suspension that forms a uniform film when applied to the nail. The polymer product is dispersed in organic solvents that vaporize rapidly upon application, which allows the suspended polymer to adhere to the contours of the nail to form a flexible, waterproof barrier over the nail. The film is colorless, transparent, and possesses good moisture vapor permeability. These properties of poly-ureaurethane, 16% ensure protection and optimal moisture balance that are the initial steps to patient satisfaction and to stronger, healthier nails.

® August 2013 | The DermaTologisT | www.the-dermatologist.com 33

The Natural Beauty & Health Blog NUV-PRSKT-0114 Reveal NuvailinyourReveal Medium www.innocutis.com To feature NUVAIL™ inamedicaljournal, publication, website orothermediaoutlet, contact: NAIL SOLUTION (poly-ureaurethane, 16%) NAIL SOLUTION (poly-ureaurethane, 16%) [email protected] [email protected] Contact Information Contact 1-843-965-8333 Charles Jenkins Charles Nuvail Nuvail Rx Only Rx Only Lydia Grossov or ™ ™ www.nuvail-rx.com