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Efficacy and Safety of Cream Containing Climbazole/Piroctone Olamine for Facial Seborrheic Dermatitis: a Single-Center, Open-Label Split-Face Clinical Study

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Efficacy and Safety of Cream Containing Climbazole/Piroctone Olamine for Facial Seborrheic Dermatitis: a Single-Center, Open-Label Split-Face Clinical Study Efficacy and Safety of C/P Cream for Facial SD pISSN 1013-9087ㆍeISSN 2005-3894 Ann Dermatol Vol. 28, No. 6, 2016 https://doi.org/10.5021/ad.2016.28.6.733 ORIGINAL ARTICLE Efficacy and Safety of Cream Containing Climbazole/Piroctone Olamine for Facial Seborrheic Dermatitis: A Single-Center, Open-Label Split-Face Clinical Study Hae Jeong Youn1, Soo Young Kim1, Minji Park2, Won Hee Jung2, Yang Won Lee1,3, Yong Beom Choe1,3, Kyu Joong Ahn1,3 1Department of Dermatology, Konkuk University School of Medicine, Seoul, 2Department of Systems Biotechnology, Chung-Ang University, Anseong, 3Research Institute of Medical Science, Konkuk University, Seoul, Korea Background: Seborrheic dermatitis (SD) is a multifactorial lient cream-treated left side. For the C/P cream, the MICs disease; Malassezia species play an important role in its were 0.625, 5, 0.625, and 2.5 mg/ml for Malassezia restricta, pathogenesis. Objective: We aimed to determine whether a M. globosa, M. sympodialis, and M. slooffiae, respectively. cream containing climbazole/piroctone olamine (C/P Conclusion: Based on the reduced casual sebum level and cream), antifungal agents with expected efficacy against extent of erythema, the antifungal activity of C/P cream Malassezia species, could improve SD symptoms. Methods: against Malassezia species seems useful for the treatment of We instructed 24 patients with mild-to-moderate SD to apply mild to moderate SD. (Ann Dermatol 28(6) 733∼739, 2016) the C/P cream and emollient cream on the right and left sides of the face, respectively, every morning and evening for 4 -Keywords- weeks. The casual sebum level (measured with SebumeterⓇ; Climbazole, Malassezia species, Piroctone olamine, Courage & Khazaka Electronic GmbH, Germany) and the ex- Seborrheic dermatitis tent of erythema (measured with MexameterⓇ; Courage & Khazaka Electronic GmbH) on the face were measured at baseline and after 4 weeks. The minimal inhibitory concen- INTRODUCTION tration (MIC) was determined to demonstrate the antifungal activity of the C/P cream. Results: The casual sebum level and Seborrheic dermatitis (SD) is a chronic dermatitis that af- erythema were measured at week 4, and the median values fects 1%∼3% of the population1. SD is characterised by demonstrated a quantitative improvement on the C/P sharply defined erythematous patches and plaques with cream-treated right side of the face compared to the emol- greasy-looking, yellowish scales on seborrheic areas such as the scalp, face, upper trunk, and flexures. The growth of Received November 13, 2015, Revised April 8, 2016, Accepted for Malassezia species was suggested as an important patho- publication April 11, 2016 genic factor of SD2,3, as demonstrated by studies that Corresponding author: Yang Won Lee, Department of Dermatology, Konkuk showed that SD was improved by the use of antifungal University School of Medicine, 120-1 Neungdong-ro, Gwangjin-gu, Seoul agents4,5. Current treatment options include antifungal 05030, Korea. Tel: 82-2-2030-5172, Fax: 82-2-2030-5179, E-mail: 20050078@ kuh.ac.kr drugs, anti-inflammatory agents (steroids, calcineurin in- This is an Open Access article distributed under the terms of the Creative hibitors, and lithium salts), keratolytic agents, and photo- Commons Attribution Non-Commercial License (http://creativecommons. therapy. SD is usually treated with topical corticosteroids org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, and antifungals. However, prolonged use of topical ste- distribution, and reproduction in any medium, provided the original work is properly cited. roids may cause adverse effects such as skin atrophy, te- Copyright © The Korean Dermatological Association and The Korean langiectasia, rosacea, and acne. The use of topical anti- Society for Investigative Dermatology fungal agents in the treatment of mild SD is well Vol. 28, No. 6, 2016 733 HJ Youn, et al established. Itraconazole can be prescribed for moderate to DS+Ⓡ), which contains climbazole and piroctone ol- severe facial SD and result in significant clinical improve- amine, on the right side of the face and emollient cream ment and decrease in the growth of Malassezia species6. (AtodermⓇ; Bioderma Laboratoire Dermatologique), a The cream containing climbazole/piroctone olamine (C/P moisturizer that does not contain climbazole and pir- cream) (Sensibio DS+Ⓡ; Bioderma Laboratoire Dermatol- octone olamine, on the left side every morning and eve- ogique, Lyon, France) tested in this study is a cosmetic ning for 4 weeks. The use of other cosmetics, therapeutic product containing piroctone olamine and climbazole. external preparations, and drugs that could affect the clin- Piroctone olamine, the ethanolamine salt of the hydroxa- ical trial was prohibited during the study. At the baseline mic acid derivative piroctone, is a hydroxypyridone an- visit and at 4 weeks, (1) SebumeterⓇ and MexameterⓇ ti-mycotic agent. Climbazole is an imidazole antifungal (Courage & Khazaka Electronic GmbH, Cologne, Germany) agent. A non-steroidal cream containing piroctone olamine were used to measure the casual sebum level and most in- was reported to effectively treat SD by inhibiting the tense erythema on the forehead and cheek on both sides; growth of Malassezia species7, and a shampoo containing and (2) patients were asked to subjectively score their itch- piroctone olamine and climbazole effectively reduced iness, burning sensation, erythema, scaling, and tightness dandruff by suppressing the growth of Malassezia8. on each side of the face as none, 0; mild, 1; moderate, 2; However, no study thus far has reported on an over- or severe, 3. This research was conducted in winter from the-counter product containing piroctone olamine and November to December. climbazole for the treatment of facial SD. We aimed to Safety evaluation evaluate the efficacy and safety of C/P cream in the treat- ment of facial SD. Safety was assessed by inquiring about local irritation or other adverse events by using questionnaires. MATERIALS AND METHODS Antifungal assay Patients To determine the antifungal activity of the C/P cream and This 4-week single-center, open-label split-face study was emollient cream against specific Malassezia species approved by the institutional review board of Konkuk strains, their minimal inhibitory concentrations (MICs) University Medical Center (IRB no. KUH1120054). All of were measured in a laboratory. MIC is the lowest concen- the patients included in this study signed an informed con- tration of antifungals or antibiotics that will inhibit the visi- sent form. The participants were 24 patients diagnosed ble growth of a microorganism after overnight incubation. with facial symmetric mild-to-moderate SD by a dermato- Malassezia restricta, M. sympodialis, and M. slooffiae logist. The severity of SD9 was determined by using two were isolated and identified at Konkuk University Medical scales; one scored erythema, plaque, infiltration, and pus- Center, South Korea, and M. globosa (Centraalbureau voor tules as absent (0), mild (1), moderate (2), or severe (3), Schimmelcultures [CBS] 7966) was purchased from the and the other scored the extent of lesions as less than 10% CBS Fungal Biodiversity Center. These strains were grown (1), 10%∼30% (2), 30%∼50% (3), 50%∼70% (4), or on Leeming and Notman agar medium10 (0.5% glucose, more than 70% (5). The total score was calculated by mul- 1% polypeptone, 0.01% yeast extract, 0.8% bile salt, tiplying the severity by the lesion area of erythema, plaque, 0.1% glycerol, 0.05% glycerol monostearate, 0.05% infiltration, and pustules, respectively, and adding the tween 60, 1.2% agar, 0.5% whole fat cow milk, and 170 scores of all four items. The total scores were categorised μg/ml chloramphenicol). Susceptibility testing of the C/P into mild (≤5 points), moderate (6∼11), or severe (12∼ cream and emollient cream was performed according to a 60). Patients who used any oral drug that could affect the method described previously11. Antifungal assays were re- condition of the skin (steroids, antibiotics, antifungal peated twice, and identical results were obtained. agents, antihistamines, etc.) within 4 weeks of study entry Statistical analysis or any therapeutic external preparation within 2 weeks of study entry were excluded. Patients with a skin disease The Wilcoxon signed rank test was used to compare the other than SD and those who underwent a facial proce- values in the C/P cream-treated area with respective val- dure within 6 months of study entry were excluded as ues in the emollient-treated area. Significance levels were well. set at p＜0.05. Analyses were performed using SPSS ver. 23.0 for Windows (SPSS Inc., Chicago, IL, USA). Treatment and assessment The patients were instructed to apply C/P cream (Sensibio 734 Ann Dermatol Efficacy and Safety of C/P Cream for Facial SD Ⓡ Ⓡ RESULTS ing Sebumeter and Mexameter , and compared at base- line and 4 weeks. At week 4, the C/P cream-treated area Study population showed a statistically significant reduction in the median The patients’ mean age was 35.37 years. We enrolled 24 casual sebum level on the forehead (marked with a black Korean patients (6 men and 18 women), none of whom bold line in Fig. 1) compared to the emollient cream-treat- withdrew from the study. ed area (p=0.011). On the cheek, the C/P cream-treated area also showed a lower median casual sebum level Efficacy of the C/P cream in comparison with that of compared to the emollient-treated area, but this was not the emollient cream statistically significant (Fig. 1). At week 4, the C/P cream-treat- ed area showed a statistically significant reduction (p=0.002) 1) Assessment of the changes in the objective SD symptoms in median erythema level compared to the emollient The casual sebum level and extent of erythema on the left- cream-treated area, on both the forehead and the cheek and right-side forehead and cheek were measured by us- (Fig.
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