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Efficacy and Safety of Halometasone Cream to Treat Chronic Generalized Eczema and the Effects of Halometasone Cream on Serum Cortisol Levels

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Efficacy and Safety of Halometasone Cream to Treat Chronic Generalized Eczema and the Effects of Halometasone Cream on Serum Cortisol Levels Hindawi BioMed Research International Volume 2017, Article ID 3265024, 7 pages https://doi.org/10.1155/2017/3265024 Clinical Study Efficacy and Safety of Halometasone Cream to Treat Chronic Generalized Eczema and the Effects of Halometasone Cream on Serum Cortisol Levels Yan Li, Wei Xu, and Linfeng Li Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China Correspondence should be addressed to Wei Xu; [email protected] Received 19 August 2017; Accepted 19 October 2017; Published 9 November 2017 Academic Editor: Fabio Sonvico Copyright © 2017 Yan Li et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The aim of the study was to investigate the efficacy and safety ofhalometasone cream to treat chronic generalized eczema and the effects of halometasone cream on serum cortisol (COR) levels. Sixty consecutive outpatients diagnosed with chronic generalized eczema between January and April 2017 were included and divided into groups A, B, and C with a lesion area of 30%–40%, 41%–50%, and51%–60%,respectively.GroupsA,B,andCweretreatedwithhalometasonecreamwithadailydoseof15g,20g,and30gfor 7–14 days, respectively. Ten patients were randomly selected from each group for serum COR measurement at days 0, 7, and 14. On day 14, group B had significantly higher cure rate (47.1%)than groups A (17.9%)and C (13.3%) and significantly higher effectiveness rate (82.4%) than group C (40.0%) (all < 0.05). Serum COR levels were not affected in group A but were reduced significantly in groups B and C on days 7 and 14 (all < 0.05). No adverse reaction was observed. Halometasone cream appeared to relieve chronic generalized eczema effectively and safely. High dosage (≥20 g daily for 14 days) may temporarily reduce endogenous COR production substantially, although it may be more effective. 1. Introduction betamethasone cream should be less than 50 g in order to prevent GC-associated severe adverse reactions [5]. Eczemaisaskininflammatorydiseaseandcanbecausedby multiple intrinsic and extrinsic factors. Chronic generalized Halometasone cream is a commonly used high-potency eczema, a common type of eczema, is characterized by lesions topical GC. It inhibits inflammation, epidermal hyperplasia, occurring at multiple sites, complex etiology, persistent recur- and allergic reactions, constrict blood vessels, and relieve rence, and severe pruritus. The disease substantially reduces pruritus. The mechanism of action of halometasone is that the quality of life of patients and imposes serious economic the drug can bind to steroid receptors to modulate the protein burden on patients [1]. Topical glucocorticoid (GC), which synthesisthatisinvolvedinthedevelopmentofchronic is commonly used to treat eczema in clinical practice, can generalized eczema and thus to regulate the function of usually relieve eczema-associated symptoms such as inflam- inflammatory cells and lysosomes and ultimately to reduce mation and pruritus rapidly [2]. Topical GC use at a proper inflammatory responses [6–8]. According to the instruction of halometasone cream, only 1.41% of halometasone cream dosage is quite safe and barely causes adverse reactions [3]. 2 However, patients with chronic generalized eczema often use used for consecutive 7 days on a lesion area of 400 cm can be topicalGCforalongtimeandatarelativelyhighdose.Wester absorbed via the skin. However, the dosage of halometasone and colleagues have found that long-term use of topical cream use in the real world is often higher than the recom- GC may cause GC to enter circulation system through skin mended dosage provided by the manufacturer. The effects of absorption, resulting in reversible hypothalamic-pituitary- topical halometasone cream on serum cortisol (COR) levels adrenal axis suppression and the consequent systemic adverse remain unknown. reactions [4]. Coureau and colleagues have demonstrated The current study aims to evaluate the efficacy and safety that the weekly dose of topical propionic acid chloride of halometasone cream to treat chronic generalized eczema 2 BioMed Research International and examine the effects of halometasone cream on serum 2.4. Serum Cortisol (COR) Measurement. Ten patients were COR levels. This study also provides clinical evidence for an randomly selected from each group for serum cortisol (COR) effective and safe dosage of halometasone cream to treat the measurement on days 0, 7, and 14. Three mL venous blood disease. was withdrawn at 8 a.m. before breakfast on days 0, 7, and 14. Patients with abnormal serum COR after the treatment 2. Materials and Methods with halometasone cream were required to come back for serum COR measurement 28 days after the termination of 2.1. Study Design. This prospective cohort study included thetreatment(day42intotal).SerumCORlevelswere consecutive outpatients visiting the Department of Derma- determined using the UniCel DxI 800 chemiluminescence tology of Beijing Friendship Hospital for chronic generalized immunoassay system (Beckman Coulter, USA) following the eczema from January to April 2017. The study protocol has manufacturer’s instruction. All reagents were provided by the been approved by the Institutional Review Board of Beijing manufacturer (Beckman Coulter, USA). The normal range of Friendship Hospital (Approval number 2017-P2-010-02). All serum COR levels was 6.0–23.0 g/dL. of the participating patients signed the informed consent form. 2.5. Halometasone Cream Efficacy Assessment. At the enroll- ment interview and each follow-up examination, the severity, 2.2. Patient Inclusion and Exclusion Criteria. The patient in- shape, and area of skin lesions were determined. The shape clusion criteria were as follows: (1) a confirmed diagnosis of skin lesions was defined as erythema (E), induration/ of chronic generalized eczema according to the diagnostic papulation (I), excoriation (Ex), and lichenification (L). criteria [10]; (2) the disease severity being at least moderate The severity score was 0, 1, 2, or 3 representing none, light, (Investigator’s Global Assessment Score ≥ 3); (3) the skin moderate, or severe, respectively. Lesion area score was 0, 1, 2, lesions being at multiple sites and affected 30% to 60% of 3, 4, 5, or 6 representing that 0%, < 10%, 10%–29%, 30%–49%, the total body surface area; (4) the target lesions being at the 50%–69%, 70%–89%, or 90%–100% of the each body region limbsortrunkandshowingadiameterof2cmto10cm;(5) area were affected by the skin lesions, respectively. Eczema adult patients aged 18 to 80 years; (6) voluntarily signing the area and severity index (EASI) was calculated according to informed consent form. the following equation: head/neck lesion area score × total Theexclusioncriteriawereasfollows:(1)skinlesions head/neck severity score (E + I + Ex + L) × 0.1 + upper limb accompanied with infection of viruses, bacteria, and/or fungi; lesion area score × total upper limb lesion severity score (2) the eczema on the face and skin-folding areas; (3) systemic (E+I+Ex+L)× 0.2 + trunk lesion area score × total trunk use of glucocorticoid and/or immunosuppressant and/or lesion severity score (E + I + Ex + L) × 0.3 + lower limb ultraviolet light therapy within 4 weeks before the enrollment lesion area score × total lower limb lesion severity score interview; (4) local use of glucocorticoid and/or oral use (E+I+Ex+L)× 0.4 [9]; efficacy index = (EASI before treat- of antihistamines within two weeks before the enrollment ment − EASI after treatment) ÷ EASI before treatment interview; (5) severe disease in the liver, kidney, and/or blood; × 100%. Completely effective, significantly effective, effective, (6) autoimmune diseases, chronic serious infection, diabetes, and not effective were defined as an efficacy index > 90%, mental diseases, substance abuse, and/or alcoholic; (7) the 60%–89%, 20%–59%, and <20%, respectively. Effectiveness malignant tumor or other serious diseases that may compro- rate = (the number of cases showing completely effect- mise the accuracy of efficacy evaluation for the study drug; ive + the number of cases showing significantly effective) ÷ (8) any other condition that the investigators believed could total number of cases × 100% [11]. interfere in the study; (9) pregnant, breastfeeding, or plan- ning to become pregnant during the study period; (10) being 2.6. Halometasone Cream Safety Assessment. Adverse reac- allergic to the study drugs; (11) failing to follow the study tions to halometasone cream were monitored during the protocol. study. Adverse reactions were discovered by telephone inter- views and in-person follow-up examinations. The severity of 2.3. Intervention. Patients received the topical treatment of adverse reactions was graded as mild, moderate, and severe. halometasone cream (trade name Aoneng, Hongkong Bright Treatments and outcomes of adverse reactions were recorded. Future Pharmaceutical, Ltd., batch number: 1601508) twice daily.Afterthecreamwasapplied,thetreatedareawas 2.7. Statistical Analyses. The statistical analysis software SPSS massaged for 5 minutes until the cream was absorbed com- 16.0 was used to analyze data. Numerical data are presented pletely. For patients with a lesion area of 30%–40% (Group as mean ± standard deviation (SD). Intragroup comparison A), 41%–50% (Group B), and 51%–60% (Group C), the daily was analyzed by paired -test and repeated measures
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