Supplement to the June 2012

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Complete Approaches to Seborrheic Dermatitis

Cheryl J. Gustafson1, MD, Scott A. Davis, MA, and Steven R. Feldman1,2,3, MD, PhD Center for Dermatology Research, Departments of 1Dermatology, 2Pathology and 3Public Health Sciences; Wake Forest University School of Medicine; Winston-Salem, North Carolina

eborrheic dermatitis (SD) is a chronic, relapsing inf lammatory skin condition that is associated with Malassezia species. Although SD affects patients of all ages, the two age peaks are infants in their first 3 months of life and adults in their fourth through seventh decades.1 The infantile form, which typically involves the scalp (cradle cap), face and diaper area, is extremely common: Up to 70% of newborns are affected by SD during their first three months of life. Typically, the infantile form of SD resolves by 1 year of age. Although SD is considered one of the most common cutaneous disorders affecting adults, estimates regarding its prevalence are limited due to the absence of validated criteria for diagnosis. Furthermore, SD isnt always recorded in community-based surveys. According to the literature, SD affects 3% to 5% of the general population; however, its true prevalence is likely considerably higher.2,3 Of note, dandruff, the mildest form of SD, is even more common, affecting 15% to 20% of the population. The National Ambulatory Medical Care Survey (NAMCS) was queried for data regarding outpatient visits for SD from 1996 to 2009. During that period, the annual number of outpatient visits for SD in the United States was approximately 1 to 2 million annually ( Figure 1). On average, there were 1.4 million visits for SD per year, with females accounting for 53.8% of these visits, and males, 46.2%

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Figure 1. Number of annual visits for seborrheic dermatitis. Data are from the National Ambulatory Medical Care Survey, a representative survey of visits to office-based physicians in the United States, performed by the National Center for Health Statistics.

Areas of Involvement Clinically, SD manifests as scaly, erythematous plaques. The most common anatomic locations affected by SD are areas rich in sebaceous glands, such as the scalp, face and thorax ( Figure 2 ).1,4 Overall, the scalp is the site most commonly affected by SD, and the face is second. 2 Areas of the face typically affected include the nasolabial folds, eyebrows, postauricular region and beard area. Additionally, SD can involve the thorax, external genitalia, and intertriginous re-

Promiseb Topical Cream is a nonsteroidal prescription cream indicated to manage and relieve the signs and symptoms of seborrheic dermatitis such as scaling, erythema, pruritus, and pain. Promiseb Topical Cream is contraindicated in persons with a known hypersensitivity to any component of the formulation. Promiseb Topical Cream does not contain milk, wheat, peanut, or animal derivatives. Promiseb Topical Cream does contain shea butter (Butyrospermum parkii), a derivative of shea nut oil (not peanut oil). Patients with known allergies to nuts or nut oils should consult their physicians before using this topical preparation. Please see accompanying important safety information and full prescribing information. The use of Promiseb Plus Scalp Wash is contraindicated for patients with a history of hypersensitivity to any of the ingredients. Massage gently upon application to loosen and help wash away flakes.
Supported by

June 2012

Supplement to The Dermatologist

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Complete Approaches to Seborrheic Dermatitis

Current Management Approaches Because SD is a chronic condition, patients require long-term maintenance therapy. Unfortunately, there is no gold standard of management for SD. The exact etiology underlying SD remains unknown. The pathogenesis likely involves a combination of the following: variation in the content of lipids on the epidermal surface, colonization by Malassezia species, and increased proliferation of the epidermis.2 Therefore, topical antifungal agents and topical corticosteroids are the principal forms of management for this inf lammatory skin condition. Of these two management modalities, antifungal agents are the mainstay, as prolonged use of topical corticosteroids is associated with well-known side effects, such as skin atrophy, striae, and telangiectasia. However, during acute SD exacerbations, topical corticosteroids are often implemented for short-term therapy. In addition to topical antifungals and corticosteroids, treatments that contain keratolytic agents such as sulfur, coal tar, and salicylic acid can help reduce skin f laking and scaling associated with SD.5 When SD involves multiple body sites, a combination of management agents in different vehicles is often used. Patient adherence is critical for acquiring effective results in managing their conditions. When devising a management strategy, the physician should encourage the patient to help make decisions. For instance, patients should be educated regarding the different therapeutic agents and asked in what vehicle they prefer the medication be delivered. SD is most commonly managed with topical agents; vehicles include creams, foams, sprays, gels, shampoos and scalp washes. Topical creams or ointments can be messy, especially when applied to the scalp and other hair-bearing regions. They often cause hair to become greasy or oily, and can cause discoloration or dryness.6

Figure 2. Clinically, seborrheic dermatitis manifests as scaly, erythematous plaques, most commonly on sebaceous gland-rich areas, such as the scalp, face and thorax

Adherence and Patient Preference Patients with chronic skin diseases frequently dont adhere to topical management regimens, which contributes to unsuccessful treatment outcomes. Factors affecting patient adherence include complexity of management regimens, cost of the products, and individual motivation to improve their health. An SD management regimen may involve a combination of different agents due to SD involvement over multiple body regions. Furthermore, different vehicles are preferred for hair-bearing and non-hair-bearing areas. As a result, effectively managing moderate to severe SD often requires combination therapy. But complicated, multi-agent regimens can pose a challenge to patient adherence. For instance, applying topical medications can be messy, time-consuming and inconvenient, especially when multiple applications per day are required. Prescribing topical combination formulations could enhance patient adherence, because using a single product can improve the ease of application. The cost burden of SD management significantly varies and affects therapeutic approach and patient adherence. We healthcare professionals routinely consider how much therapies will cost patients out of pocket at the pharmacy. This sensitivity has become more widespread over the last several years, as the economy has increasingly affected individuals. SD is a chronic, recurring inf lammatory skin disease requiring that patients use one or more topical agents on a long-term basis. As such, it stands to reason

Promiseb Topical Cream is a nonsteroidal prescription cream indicated to manage and relieve the signs and symptoms of seborrheic dermatitis such as scaling, erythema, pruritus, and pain. Promiseb Topical Cream is contraindicated in persons with a known hypersensitivity to any component of the formulation. Promiseb Topical Cream does not contain milk, wheat, peanut, or animal derivatives. Promiseb Topical Cream does contain shea butter (Butyrospermum parkii), a derivative of shea nut oil (not peanut oil). Patients with known allergies to nuts or nut oils should consult their physicians before using this topical preparation. Please see accompanying important safety information and full prescribing information. The use of Promiseb Plus Scalp Wash is contraindicated for patients with a history of hypersensitivity to any of the ingredients. Massage gently upon application to loosen and help wash away flakes.

June 2012

Supplement to The Dermatologist

Photos courtesy of James Q. Del Rosso, DO, FAOCD.

gions such as the axillae, inframammary region and inguinal folds. 5 Although patients often have multiple body regions affected by SD, no studies in the medical literature have reported the percentage of patients who have multiple anatomical regions affected by SD. This is likely because SD is a chronic disease characterized by periods of remission and exacerbation. As a result, a single patient may have SD localized to a single body region during a mild episode. However, the same patient may have multiple skin sites involved during an exacerbation period.

Complete Approaches to Seborrheic Dermatitis

that the management should be highly effective, easy to use and economically priced. Formulations that appeal to patients can be used to encourage adherence. Generally, patients prefer lessmessy vehicles, though there is considerable variation between patients preferences.7 Patients often prefer products in the form of shampoo (e.g., scalp wash), foam or gel when managing inf lammatory disorders involving the scalp.7 Likewise, sprays, foams or gels are preferred when SD involves other hair-bearing regions, such as the beard area, chest or external genitalia. Products formulated as scalp washes may provide greater convenience than conventional creams or ointments for SD involving the scalp. One potential benefit of scalp washes is that they are applied directly to the f lakes on the scalp for a relatively short period of time before being rinsed from the hair, whereas creams and ointments can be less cosmetically appealing, as they are leave-on products that remain on the skin for extended periods of time. Furthermore, scalp washes can be easily implemented into patients management regimens as they are incorporated into routine washing habits. New Regimen for SD That Includes the Scalp and Hair-Bearing Areas Brought to market in 2009, Promiseb Topical Cream is a non-steroidal topical agent used to manage SD. The efficacy of Promiseb Cream versus desonide cream 0.05% was assessed in an investigator-blinded, randomized, 4-week pilot study.8 Seventy-seven patients with SD of the face were randomized to two groups: twicedaily management with Promiseb Cream, and twicedaily management with desonide cream 0.05%. At the end of the 28-day study period, both management groups exhibited similar reductions in the severity of facial SD. Approximately 90% of patients achieved complete or near-complete clearance. Additionally, both topical agents were associated with significantly reducing erythema, scaling and pruritus. Of note, patients using Promiseb Cream had lower relapse rates of SD compared to patients who used the low-potency steroidal cream (P < 0.02).9 Twenty-five patients with mild to severe flaky build-up on the scalp participated in a 2-week open study of Promiseb Plus Scalp Wash.10 All patients used the product approximately twice a week; some left the lather on the scalp for several minutes before rinsing. Scalp dermoscopy revealed a decreased quantity of flakes. The effect on hair

cosmetics was rated positive by all patients. The scent and quantity of the lather were rated as optimal, and all patients said they would buy the product if it were on the market.10 A cream and scalp wash combination regimen is now available as Promiseb Complete (30 g tube of cream and 100 ml bottle of scalp wash), which may appeal to some patients. Conclusion Seborrheic dermatitis is a chronic disease for which adherence to treatment may be a barrier. The availability of a range of non-steroidal options may help promote good adherence, can complement or replace topical steroid treatments, and may help avoid long-term corticosteroid side effects, all while promoting good patient outcomes. n
References 1. Peyri J, Lleonart M. [Clinical and therapeutic profile and quality of life of patients with seborrheic dermatitis]. Actas Dermosifiliogr. 2007;98(7):476482. 2. Naldi L, Rebora A. Clinical practice. Seborrheic dermatitis. N Engl J Med. 2009;360(4):387396. 3. Bikowski J. Facial seborrheic dermatitis: a report on current status and therapeutic horizons. J Drugs Dermatol. 2009;8(2):125133. 4. Hay RJ. Malassezia, dandruff and seborrhoeic dermatitis: an overview. Br J Dermatol. 2011;165 Suppl 2:28. 5. Gupta AK, Bluhm R. Seborrheic dermatitis. J Eur Acad Dermatol Venereol. 2004;18(1):1326. 6. Wozel G. Psoriasis treatment in difficult locations: scalp, nails, and intertriginous areas. Clin Dermatol. 2008;26(5):448459. 7. Kurian A, Barankin B. Delivery vehicle advances in dermatology. SkinTherapyLetter.com. 2001:7(2). Available from http://www.skintherapyletter.com/fp/2011/7.2/2.html 8. Elewski B. An investigator-blind, randomized, 4-week, parallelgroup, multicenter pilot study to compare the safety and efficacy of a nonsteroidal cream (Promiseb Topical Cream) and desonide cream 0.05% in the twice-daily treatment of mild to moderate seborrheic dermatitis of the face. Clin Dermatol. 2009;27(6 Suppl):S48S53. 9. Data on file. A randomized pilot study to compare the safety and efficacy of Promiseb Topical Cream and desonide cream 0.05% in the treatment of mild to moderate seborrheic dermatitis of the face. Promius Pharma, LLC: Bridgewater, NJ; 2008. 10. Piraccini BA. Treatment of seborrheic dermatitis of the scalp with MAS067D (Sebclair Shampoo): an open study on 25 patients using scalp dermoscopy. Poster. European Academy of Dermatology and Venereology, October 610; 2009. Gothenburg, Sweden.

This supplement was supported by Promius Pharma, LLC. Copyright 2012 and published by The Dermatologist/HMP Communications, LLC, Malvern, PA. All rights reserved. No part of this publication may be reproduced or transmitted in any form, by any means, without prior written permission of the publisher. The opinions or views expressed in this professional educational supplement are those of the presenter and do not necessarily reflect the opinions or recommendations of the supporter or The Dermatologist.

Promiseb Topical Cream is a nonsteroidal prescription cream indicated to manage and relieve the signs and symptoms of seborrheic dermatitis such as scaling, erythema, pruritus, and pain. Promiseb Topical Cream is contraindicated in persons with a known hypersensitivity to any component of the formulation. Promiseb Topical Cream does not contain milk, wheat, peanut, or animal derivatives. Promiseb Topical Cream does contain shea butter (Butyrospermum parkii), a derivative of shea nut oil (not peanut oil). Patients with known allergies to nuts or nut oils should consult their physicians before using this topical preparation. Please see accompanying important safety information and full prescribing information. The use of Promiseb Plus Scalp Wash is contraindicated for patients with a history of hypersensitivity to any of the ingredients. Massage gently upon application to loosen and help wash away flakes.

June 2012

Supplement to The Dermatologist

For Topical Dermatological Use Only For External Use Only Rx only

Product Description: Promiseb Topical Cream is an off-white, steroid-free, fragrance-free, water-based emulsion. Indications for Use: Under the supervision of a healthcare professional, Promiseb Topical Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Promiseb Topical Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. Directions for Use: Apply Promiseb Topical Cream to the affected skin areas 2 to 3 times per day (or as needed), and massage gently into the skin. If the skin is broken, cover Promiseb Topical Cream with a dressing of choice. Ingredients: Promiseb Topical Cream is comprised of Purified Water, Isohexadecane, Butyrospermum parkii, Pentylene glycol, Ethylhexyl palmitate, Cera alba, PEG30 Dipolyhydroxystearate, Bisabolol, Polyglyceryl-6 polyricinoleate, Tocopheryl acetate, Hydrogenated castor oil, Acifructol complex, Butylene glycol, Magnesium sulfate, Piroctone olamine, Allantoin, Magnesium stearate, Disodium EDTA, Vitis vinifera, Ascorbyl tetraisopalmitate, Glycyrrhetinic acid, Propyl gallate, and Telmesteine.

Caution: The use of Promiseb Topical Cream is contraindicated in any patient with a known history of hypersensitivity to any of the ingredients. Promiseb Topical Cream does not contain milk, wheat, peanut or animal derivatives. Promiseb Topical Cream does contain shea butter (Butyrospermum parkii), a derivative of shea nut oil (not peanut oil). Patients with a known allergy to nuts or nut oils should consult their physician before using this topical preparation. How Supplied: 30 g tube, 67857-803-30 To Open: Puncture seal with pointed end of cap. Important: The opening of this product is covered by a metal seal. Do not use if seal has been punctured or is not visible. Store at controlled room temperature 68 to 77F (20 to 25C), excursions permitted between 59 and 86F (15 and 30C). Distributed by Promius Pharma, LLC, Bridgewater, NJ 08807

Made in Italy Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. R 0209 150-210