• Title/Summary/Keyword: Healthy volunteers

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Development and Evaluation of the Utility of a Respiratory Monitoring and Visual Feedback System for Radiotherapy Using Machine Vision Technology

  • Kim, Chul Hang;Choi, Hoon Sik;Kang, Ki Mun;Jeong, Bae Kwon;Jeong, Hojin;Ha, In Bong;Song, Jin Ho
    • Journal of Radiation Protection and Research
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    • v.47 no.1
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    • pp.8-15
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    • 2022
  • Background: We developed a machine vision technology program that tracks patients' real-time breathing and automatically analyzes their breathing patterns. Materials and Methods: To evaluate its potential for clinical application, the image tracking performance and accuracy of the program were analyzed using a respiratory motion phantom. Changes in the stability and regularity of breathing were observed in healthy adult volunteers according to whether the breathing pattern mirrored the breathing guidance. Results and Discussion: Displacement within a few millimeters was observed in real-time with a clear resolution, and the image tracking ability was excellent. This result was consistent even in the sections where breathing patterns changed rapidly. In addition, the respiratory gating method that reflected the individual breathing patterns improved breathing stability and regularity in all volunteers. Conclusion: The findings of this study suggest that this technology can be used to set the appropriate window and the range of internal target volume by reflecting the patient's breathing pattern during radiotherapy planning. However, further studies in clinical populations are required to validate this technology.

Application of Spatial Modulation of Magnetization to Cervical Spinal Stenosis for Evaluation of the Hydrodynamic Changes Occurring in Cerebrospinal Fluid

  • Kwang-Hun Lee;Tae-Sub Chung;Tae Joo Jeon;Young Hwan Kim;Daisy Chien;Gerhard Laub
    • Korean Journal of Radiology
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    • v.1 no.1
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    • pp.11-18
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    • 2000
  • Objective: To evaluate the hydrodynamic changes occurring in cerebrospinal fluid (CSF) flow in cervical spinal stenosis using the spatial modulation of magnetization (SPAMM) technique. Materials and Methods: Using the SPAMM technique, 44 patients with cervical spinal stenosis and ten healthy volunteers were investigated. The degree of cervical spinal stenosis was rated as low-, intermediate-, or high-grade. Low-grade stenosis was defined as involving no effacement of the subarachnoid space, intermediate-grade as involving effacement of this space, and high-grade as involving effacement of this space, together with compressive myelopathy. The patterns of SPAMM stripes and CSF velocity were evaluated and compared between each type of spinal stenosis and normal spine. Results: Low-grade stenosis (n = 23) revealed displacement or discontinuity of stripes, while intermediate- (n = 10) and high-grade (n = 11) showed a continuous straight band at the stenotic segment. Among low-grade cases, 12 showed wave separation during the systolic phase. Peak systolic CSF velocity at C4-5 level in these cases was lower than in volunteers (p < .05), but jet-like CSF propulsion was maintained. Among intermediate-grade cases, peak systolic velocity at C1-2 level was lower than in the volunteer group, but the difference was not significant (p > .05). In high-grade stenosis, both diastolic and systolic velocities were significantly lower (p < .05). Conclusion: Various hydrodynamic changes occurring in CSF flow in cervical spinal stenosis were demonstrated by the SPAMM technique, and this may be a useful method for evaluating CSF hydrodynamic change in cervical spinal stenosis.

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Effect of administration of synbiotics mixture containing Bifidobacterium longum and xylooligosaccharide on fecal microbiota and defecation characteristics in healthy volunteers (Bifidobacterium longum과 자일로올리고당을 포함한 synbiotics 섭취가 건강한 성인의 변내 균총과 배변 상태에 미치는 영향)

  • Lee, Jung-Sug;Park, Hyoung-Seop;Kyung, Myungok;Jo, Sung-Eun;Chang, Moon-Jeong
    • Journal of Nutrition and Health
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    • v.53 no.4
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    • pp.390-405
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    • 2020
  • Purpose: The effect of prebiotics intake after administration of a synbiotics mixture (a probiotic, Bifidobacterium longum, and a prebiotic, xylooligosaccharide containing sugar [XOS]) on human intestinal microflora and defecation characteristics was investigated in a randomized controlled trial. Methods: Twenty-five healthy young volunteers (11 males and 14 females) were randomly assigned to 2 groups (BL2XO2 and BL2XO6). The synbiotics mixture was orally administered to both groups for 2 weeks, and the prebiotics were subsequently administered to the BL2XO6 group for 4 additional weeks. The daily dose of the synbiotics mixture comprised 1010 colony-forming unit of Bifidobacterium longum and 10 g of XOS, and during the prebiotics period, the daily dose of prebiotics comprised only 10 g of XOS. The fecal pH, microflora, and defecation characteristics were analyzed at baseline and at weeks 1, 2, 4, and 6. Results: The counts of B. longum and Bifidobacterium spp. in the BL2XO6 group exhibited a steady, increasing trend during the synbiotics and prebiotics periods, whereas those of the BL2XO2 group exhibited considerable variation in each week of the study period. Although there was no significant difference, the counts of fecal Bifidobacterium in the BL2XO6 group tended to be higher than those of the BL2XO2 group at week 6. The growth of Lactobacillus spp. exhibited a time-dependent variation, peaking at week 6 in both groups. Low counts of Clostridium spp. were observed after treatment with the synbiotics and prebiotics in the BL2XO6 group (p < 0.05) throughout the study, whereas the inhibitory effect on Clostridium spp. was maintained only during the synbiotics period in the BL2XO2 group. The defecation characteristics did not differ between the two groups. Conclusion: Administration of XOS after a synbiotics mixture containing B. longum and XOS can exert a prebiotic effect in healthy young volunteers by stimulating Bifidobacteriun spp. growth and inhibiting growth of Clostridium spp.

Changes in the Sensory Function after Transcranial Direct Stimulation on Dorsolateral Prefrontal Cortex Area (배외측전전두엽피질 영역에 경두개직류전류자극이 감각기능에 미치는 영향)

  • Min, Dong-Ki
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.16 no.1
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    • pp.445-452
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    • 2015
  • Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that delivers a low-intensity direct current to the cortical areas, thereby facilitating or inhibiting spontaneous neuronal activity. This study was designed to examine the changes in various sensory functions after tDCS. A single-center, single-blinded, randomized trial was conducted to determine the effect of a single session (August 4 to August 29) of tDCS with the current perception threshold (CPT) in 50 healthy volunteers. Nerve conduction studies (NCS) were performed in relation to the median sensory and motor nerves on the dominant hand to discriminate peripheral nerve lesions. The subjects received anodal tDCS with 1mA for 15 minutes under two different conditions, with 25 subjects in each group. The conditions were as follows: tDCS on the dorsolateral prefrontal cortex (DLPFC) and sham tDCS on DLPFC. The parameters of the CPT was recorded with a Neurometer$^{(R)}$ at frequencies of 2000, 250 and 5 Hz in the dominant index finger to assess the tactile sense, fast pain and slow pain, respectively. In the test to measure the CPT values of the DLPFC in the anodal tDCS group, the values increased significantly in all of 250 and 5 Hz. All CPT values decreased for the sham tDCS. These results showed that DLPFC anodal tDCS can modulate the sensory perception and pain thresholds in healthy adult volunteers. This study suggests that tDCS may be a useful strategy for treating central neurogenic pain in rehabilitation medicine.

Bioequivalence Study of Toriem® Tablet to Motilium-M® Tablet (Domperidone Maleate 12.72 mg) Evaluated by Liquid Chromatography/Tandem Mass Spectrometry

  • Ryu, Ju-Hee;Choi, Sang-Jun;Lee, Myung-Jae;Lee, Jin-Sung;Kang, Jong-Min;Tak, Sung-Kwon;Seo, Ji-Hyung;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.39 no.1
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    • pp.65-71
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    • 2009
  • The aim of the present study was to evaluate the bioequivalence of two domperidone maleate tablets, Motilium-$M^{(R)}$ Tablet (Janssen Korea Ltd., reference product) and $Toriem^{(R)}$ Tablet (Daewon Pharm. Co., Ltd., test product). Domperidone was extracted by liquid-liquid extraction using tert-butyl methyl ether and separated in less than 3 min on $C_{18}$ reverse-phase column using an isocratic elution. A tandem mass spectrometer, as detector, was used for quantitative analysis in positive mode by a multiple reaction monitoring mode to monitor the m/z $426.1{\rightarrow}119.1$ and the m/z $837.4{\rightarrow}158.2$ transitions for domperidone and the internal standard (roxithromycin), respectively. Calibration curves, from $0.05{\sim}50$ ng/mL of domperidone, showed correlation coefficients (r) higher than 0.9941. Intra day and inter day precision (C.V. %) for quality control were ranged from 10.04 to 16.09% and from 10.87 to 18.69%, respectively. The lower limit of quantification (LLOQ) of domperidone was 0.05 ng/mL. The method described is precise and sensitive and has been successfully applied to the study of bioequivalence of domperidone in 24 healthy Korean volunteers. Twenty-four healthy male Korean volunteers received a single dose of each medicine ($2{\times}12.72\;mg$ domperidone maleate) in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of domperidone were monitored for over a period of 24 hr after the administration. $AUC_{0-t}$ (the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. The 90% confidence intervals for the log transformed data were within acceptable range of log 0.8 to log 1.25 (e.g., $log\;0.92{\sim}log\;1.05$ for $AUC_{0-t}$, $log\;0.81{\sim}log\;1.05$ for $C_{max}$). The major parameters, $AUC_{0-t}$ and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that $Toriem^{(R)}$ tablet is bioequivalent to Motilium-$M^{(R)}$ tablet.

In vitro Dissolution and in vivo Bioequivalence Study of Controlled Release Carbamazepine Formulation (Epileptol CR® vs Tegretol CR® in Healthy Male Korean Volunteers

  • Kim, Ji-Young;Kim, Hyung-Tae;Kim, Chong-Kook
    • Journal of Pharmaceutical Investigation
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    • v.38 no.5
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    • pp.335-342
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    • 2008
  • The bioequivalence of two carbamazepine preparations was conducted. The in vivo bioequivalence study in 20 healthy male Korean volunteers was designed by using a single dose, randomized, 2-period crossover with a 3-weeks washout period between the doses. Prior to the in vivo study, an in vitro comparative dissolution test was performed by the paddle and basket method as described in the bioequivalence guidance of the Korea Food and Drug Administration (KFDA). Based on the similar dissolution pattern between two preparations in the dissolution test, the two formulations are demonstrated to be pharmaceutically equivalent. In addition, in vivo bioequivalence test was used to reconfirm the in vitro dissolution results. In the in vivo bioequivalence study, the plasma concentrations of carbamazepine up to 144 h after the administration were determined using a validated HPLC method with UV detection and the bioequivalence between the two drug products was assessed by statistical analysis of the log transformed mean ratios of $C_{max}$, $AUC_{0-t}$ and $AUC_{0-\infty}$. The mean maximum concentration ($C_{max}$) of the test and reference were found to be $1467.0{\pm}335.8\;ng/mL$ and $1465.9{\pm}310.3\;ng/mL$, respectively. The 90% confidence intervals (C.I.) of $C_{max}$ were in the range from 0.95 to 1.05. As for the $AUC_{0-t}$ and $AUC_{0-\infty}$, test values were $110027.1{\pm}27786.4\;ng/mL{\cdpt}h$, $128807.0{\pm}34563.2\;ng/mL{\cdot}h$ and $105473.6{\pm}26496.2\;ng/mL{\cdot}h$, $125448.5{\pm}35975.5\;ng/mL{\cdot}h$, respectively. The 90% C.I. of $AUC_{0-t}$ were 0.97 to 1.10 and of $AUC_{0-\infty}$, 0.99 to 1.09 and thus were within the log 0.8-log 1.25 interval proposed by the KFDA. A two-way ANOVA showed no significant difference between the two formulations. Based on these statistical analysis, it was concluded that the test formulation is bioequivalent to the reference.

Enhanced Transdermal Delivery of Procaine Hydrochloride by lontophoresis -Comparison of Synergic Effect of High Voltage Current and Ultrasound- (이온도입에 의한 염산프로카인의 경피전달 증대 -고전압전류 및 초음파 병행의 상승효과 비교-)

  • Lee, Jong-Sook;Kim, Kyoung-Won;Lee, Jae-Hyoung;Choi, Yeong-Wook;Lee, Jae-Hwi
    • Journal of Pharmaceutical Investigation
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    • v.36 no.3
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    • pp.185-192
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    • 2006
  • The purpose of this study was to determine the effects of iontophoresis on transdermal delivery of procaine hydrochloride in healthy volunteers, as well as to the synergic effect of high voltage current or ultrasound on the efficacy of transdermal delivery of iontophoresis. Forty healthy volunteers were randomly assigned to four groups topical application group (TA), iontophoresis group (IT), pre-treatment of high voltage current stimulation with iontophoresis (HVS + IT), and pre-treatment of ultrasound application with iontophoresis (US + IT). All subjects received procaine iontophoresis on the forearm using direct current with 4 mA f3r 15 minutes. All subject was measured the duration of local anesthesia, pressure pain threshold, pain perception threshold using rectangular wave at 0.2 ms, 1 ms, 50 ms of rectangular current stimulation after procaine iontophoresis. For comparisons of the sensory characteristics and efficacy of iontophoresis between the groups, an one-way ANOVA and Kruskal-Wallis were used. The significant difference the duration of local anesthesia were found between the groups (p<0.001). The local anesthetic duration of IT, HVS+IT were significantly longer than TA. Meanwhile, the local anesthetic duration of US+IT was significantly longer than HVS+IT, IT and TA group (p<0.05). Also, the pressure pain threshold, pain perception threshold at 0.2 ms, 1 ms, 50 ms were significant difference between the groups (p<0.001). All sensory characteristics including pressure pain threshold, pain perception threshold of IT, HVS+IT was significantly increased than TA, whereas, US+1T was significantly increased HVS+1T, IT and TA (p<0.05). This study showed that the procaine iontophoresis have increase the duration of local anesthesia concomitantly pressure pain threshold and pain perception threshold of sensory nerve fibers such as $A-{\beta}$, $A-{\delta}$ and C fiber. This findings suggest that the iontophoresis enhanced the transdermal delivery of drug ions in vivo. The combination of ultrasound application and iontophoresis synergized the transdermal delivery of drug ions. It is suggests that an electric field, mechanical and heating property of ultrasound may contribute to synergic effect due to temporary changes of structure in the stratum corneum.

The Effects of distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture on the Heart Rate Variability (녹용 약침과 산조인 약침이 정상인의 심박변이도(HRV)에 미치는 영향)

  • Kim, Hui-Jun;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Pharmacopuncture
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    • v.12 no.3
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    • pp.31-40
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    • 2009
  • Objective : This study was to investigate the effects of distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture on autonomic nervous system with Heart Rate Variability(HRV). Purpose of the trial was to observe what influence distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture have on the autonomic nervous system. Methods : 60 healthy male volunteers were divided into three groups which consist of two experimental groups such as Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture, and a control group. Study design was a randomized, placebo-controlled, double-blind clinical trial. 20 subjects in experimental group were injected distilled Cervi Pantotrichum Cornu Pharmacopuncture at $GB_{21}$(Kyonjong), 20 subjects in other experimental group were injected distilled Zizyphi Spinosi Semen Pharmacopuncture and 20 subjects in control group were injected Normal Saline at $GB_{21}$(Kyonjong). One volunteer of each groups were excluded from analysis because of error during measuring HRV. At the end of the study 57 volunteers completed HRV analysis. HRV was measured by QECG-3:LXC3203(LAXTHA Inc. Korea) at P0, P1, P2, P3, P4, P5 and P6 and its time-course dependent change in each group was analyzed using paired t-test, and the difference of HRV fluctuation among two experimental group and a control was evaluated by one way ANOVA(p<0.05). Results : A. Time Domain Analysis 1. Analysis of Mean HRV, SDNN and Complexity After injection of distilled Cervi Pantotrichum Cornu Pharmacopuncture, Mean HRV was significantly decreased only at 20 minutes after injection. SDNN was significantly increased from 15 minute after injection. Complexity was significantly decreased only at 15 minute after injection. After injection of distilled Zizyphi Spinosi Semen Pharmacopuncture, Complexity was significantly decreased at 10, 15 and 30 minutes after injection. 2. Analysis of HRV index, pNN50 After injection of distilled Cervi Pantotrichum Cornu Pharmacopuncture, pNN50 was significantly decreased at 15, 20 and 25 minutes after injection. Compared with Normal Saline injection, distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture showed significant difference on HRV index and pNN50 at 5 minutes after injection. B. Frequency Domain Analysis 1. Analysis of Ln(TP), Ln(VLF) After injection of distilled Cervi Pantotrichum Cornu Pharmacopuncture, Ln(TP) was significantly increased at 15 and 30 minutes after injection. Ln(VLF) was significantly increased at 10, 15 and 30 minutes after injection. After injection of distilled Zizyphi Spinosi Semen Pharmacopuncture, Ln(VLF) was significantly increased only at 30 minutes after injection. Compared with Normal Saline injection, distilled Cervi Pantotrichum Cornu Pharmacopuncture showed significant difference on Ln(TP) after 5 minutes of injection. Conclusions : Our results suggest that Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture in healthy adult man tend to activate the autonomic nervous system and sympathetic nervous system compared to Normal Saline within normal range.

IN VITRO EFFECT OF PANAX GINSENG ON PHYTOHAEMAGGLUTININ-INDUCED LYMPHOCYTE TRANSFORMATION AND ITS IN VIVO EFFECT (식물성 혈구 응집소(Phytohaemagglutinin)로 유도한 림파구 변형에 관한 인삼의 in vitro 및 in vivo효과)

  • Chong S.K.F.;Brown H.A.;Rimmer E.;Oberholzer V.;Hindocha P.;Walker-Smith J .A.;Carruthers L.
    • Proceedings of the Ginseng society Conference
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    • 1984.09a
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    • pp.89-95
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    • 1984
  • The effect of hydrocortisone or Panax ginseng, and/or a combination of hydrocortisone and Panax ginseng on phytohaemagglutinin (PHA-P)-induced transformation of peripheral blood lymphocytes were studied in 4 normal healthy adult volunteers. Increasing concentrations of Panax ginseng 0.16-1.60${\mu}g$/ml caused a doserelated inhibition of PHA-P transformation of lymphocytes. A combination of 500${\mu}g$/ml hydrocortisone and 0.80${\mu}g$/ml Panax ginseng produced a greater suppression of PHA-P stimulation than either drug used alone. This suggests that Panax ginseng has a steroid-like effect in vitro, and may have a potentiating effect with hydrocortisone on T-cell mediated immunity. The in vivo effects of Panax ginseng were further studied in 6 healthy adult volunteers. PHA-P transformation studies were performed before and after Panax ginseng capsules were taken for 2 weeks and at a higher dosage at 4 weeks. Our results showed that in 3 subjects, there was significant inhibition of PHA-P transformation at 4 weeks.

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Preliminary Research of the effect of Korean Herbal Cosmetic on Quality ofLife based on Dermatology Life Quality Index(DLQI) in Healthy Women (한방화장품이 건강한 성인 여성의 삶의 질에 미치는 영향에 관한 예비 연구)

  • Cho, Ga-Young;Park, Hyo-Min;Kwon, Lee-Kyung;Cho, Sung-A;Kang, Byung-Young;Kim, Yoon-Bum
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.28 no.4
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    • pp.111-121
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    • 2015
  • Objective : The aim of this study is to assess the effect of Korean Herbal Cosmetic on quality of life (QoL) of Korean Herbal Cosmetics Using Dermatology Life Quality Index (DLQI) stratified by blind versus non-blinded option.Methods : Forty five healthy females aged 30's to 40's were recruited for this study. Volunteers were divided into two groups : Group A (n=22) was provided an anti-aging cream with ginseng extract in the original packaging including the brand name and logo. Group B (n=23) were provided same cream in a plain white normal jar without any package decoration or logo.Results : All females except two volunteers in group A completed a DLQI questionnaire, baseline, after 4 weeks and 8 weeks of treatment. The baseline of DLQI scores of all groups was 3.23±2.72. There was a significant difference in DLQI scores between before, 4 weeks and 8 weeks after in both groups ; The scores changed from 4.25±3.45 to 0.95±1.15 at 4 weeks, 1.00±1.72 at 8 weeks in group A, The scores of group B changed from 2.35±1.47 to 0.83±1.23 at 4 weeks, 0.65±0.98 at 8 weeks. But both had no interaction effect between follow up times and groups. Subscale DLQI scores improved after 4weeks were 'Symptoms and feelings', only in group BConclusions : Both groups showed significant improvements in QoL quality scores evaluated by DLQI. However, interaction was not observed for whether the participants knew the brand and content of the cream.