Journal of Clinical and Aesthetic Dermatology

APR 2017

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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17 JCAD journal of clinical and aesthetic dermatology April 2017 • Volume 10 • Number 4 S O bjective: Seborrheic dermatitis is a common relapsing inflammatory skin c ondition occurring in approximately 3 to 5 percent of the general population. Current available therapies control, but do not cure seborrhea. The study's objective was to determine the safety and efficacy of a barrier-based, nonsteroidal cream incorporating herbal extracts as a treatment for facial seborrheic dermatitis. Design: Interventional, open label, safety/efficacy study. Setting: At the baseline visit, the investigator selected a target area on the face. The target area was evaluated for Investigator Static Global Assessment, desquamation (scaling), induration (inflammation), and erythema (redness) as well as self-assessed pruritus. Participants: Thirty-two subjects with seborrheic dermatitis were enrolled in the study. Measurements: Subjects were instructed to use the study medication twice a day, morning and evening, for a consecutive period of 42 days. In addition to the baseline visit (Day 0), subjects visited the clinic for two follow-up visits at Days 14 and 28 and for a Inal visit at Day 42. At each visit, all [Abstract continued on next page] A B S T R A C T o R I G I n A L R E S E A R C H Treatment of Seborrheic Dermatitis Using a Novel Herbal-based Cream a DEGANIT BARAK-SHINAR, PhD; b RUBEN DEL RÍO, MD; c LAWRENCE J. GREEN, MD aa Kamedis Ltd., Tel-Aviv, Israel; b Esperit Sant Hospital of Santa Coloma de Gramenet, Barcelona, Spain; c George Washington University School of Medicine, Washington, D.C. Seborrheic dermatitis (SD) is a common relapsing inflammatory skin condition occurring in approximately 3 to 5 percent of the general population, with a worldwide distribution. SD affects newborns, infants, and adults; occurs in all races; and severity is higher in males than in females. Up to 70 percent of infants in the first three months of life may develop the condition. The prevalence of SD is increasing to 30 to 83 percent in human immunodeficiency virus (HIV)-positive and acquired immunodeficiency syndrome (AIDS) patients. SD is related to cradle cap or diaper rash. It is commonly worsened by changes in environment humidity, changes in seasons, trauma, or emotional stress. 1,2 Symptoms of SD include excessive sebum production (hyperseborrhea), erythematous plaques with scales, and frequent pruritus. 3,4 Available topical therapies temporarily control the symptoms, but do not cure the condition. 5,6 Treatment for mild-to-moderate cases include antimycotic agents 7 (e.g., Disclosure: Dr. Barak-Shinar is an employee of Kamedis Ltd., the manufacturer of Seborrheamedis Face Cream and the sponsor of this study. Dr. del Río is the Principle Investigator of the Seborrheamedis Face Cream clinical trial. Dr. Green serves on the medical advisory board for Kamedis. The study was conducted in accordance with the Declaration of Helsinki. This study was wholly funded by Kamedis Ltd. Author correspondence: Deganit Barak-Shinar, PhD; E-mail: deganit@kamedis.com

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