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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18 JCAD journal of clinical and aesthetic dermatology April 2017 • Volume 10 • Number 4 o R I G I n A L R E S E A R C H ketoconazole, bifonazole, and ciclopirox); zinc pyrithione; lithium salts and coal tars in shampoos; and selenium sulfide in shampoos, creams, and foams. 2 Although the pathogenesis of seborrheic dermatitis has not been completely elucidated, there appears to be a strong association with yeasts of the genus Malassezia. 7–10 Malassezia has been found on affected sites, and reduction of yeast populations by treatment with antifungals is effective in providing relief for seborrheic dermatitis. 1 1 However, the pathogen's (Malassezia) resistance to antifungal agents has also been documented. 6 ,7 Seborrhea can also be treated with low or medium potency topical corticosteroids or calcineurin inhibitors (e.g., tacrolimus and pimecrolimus). These immunomodulatory agents are highly effective as anti-inflammatory agents, but long-term continuous use should be avoided because of their risk of causing addiction and steroid rosacea. 8 In very severe cases, ultraviolet B (UVB) phototherapy is often considered. 11 Seborrheamedis Face Cream (Kamedis, Israel) is a barrier-based, nonsteroidal cream incorporated with herbal extracts designed to manage the clinical manifestations and symptoms of facial seborrheic dermatitis, such as erythema, scaling, and pruritus. The aim of this study was to determine the safety and efficacy of this face cream applied twice daily for 42 days in the treatment of SD. METHODS Thirty-two male and female subjects over the age of 18 were enrolled in a single-center, prospective, open-label, institutional review board (IRB)-approved, six- week study. All subjects had mild Investigator Static Global Assessment (ISGA = 2) to moderate (ISGA = 3) facial seborrheic dermatitis. At the baseline visit, the investigator selected a target area on the face. The target area was evaluated for desquamation (scaling), induration (inflammation), and erythema (redness) using a 5-point scale: 0=none, 1=minimal, 2=mild, 3=moderate, and 4=severe. The target area was photographed. In addition, the investigator assessed the extent of overall facial lesions using an ISGA based on a 6-point scale: 0=clear (no inflammatory signs of SD), 1=almost clear (just perceptible erythema and just perceptible papulation/induration), 2=mild (mild erythema and mild papulation/induration), 3=moderate (moderate erythema and moderate papulation/induration), 4=severe (severe erythema and severe papulation/induration), 5=very severe (very severe erythema and very severe papulation/induration with oozing/crusting). The ISGA provides the overall evaluation of the physician, taking into consideration all condition symptoms. Using a 6- point scale enables a standard definition per each scale, which assists in converting the data into an effective and efficient clinical report. The subject evaluated his/her pruritus over the past 24 hours using a 5-point scale: 0=no itching, 1=minimal and rare itching, 2=mild itching, (subject is aware of the itching only when relaxed), 3=moderate itching (subject is often aware of the itching, which [Abstract continued] parameters were evaluated. R esults: A reduction in all parameters evaluated was seen at almost all timepoints, improving more from one timepoint to the next during the study period. In addition, the patients expressed a high degree of satisfaction with the treatment. no adverse events were reported during this study. Conclusion: The study showed that after six weeks of treatment, the face cream provided improvement in Investigator Static Global Assessment, pruritus, desquamation, induration, and erythema. ClinicalTrials.gov Identifier: nCT02656368 (https://clinicaltrials.gov/ct2/sh ow/nCT02656368?term=Kame dis&rank=2) J Clin Aesthet Dermatol. 2017;10(4):17–23.

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