• Journal of Pharmaceutical Investigation
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• v.34 no.6
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• pp.529-540
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• 2004

After new medical system of separation of dispensary from medical practice was started in 2000 in Korea, to expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drugs are hot issues in Korea. It will be obligatory to submit bioequivalence reports for getting licenses of all generic prescription drugs in the near future. Like other countries such as US and Japan, the KFDA also has a plan to re-evaluate the already approved drugs by bioequivalence studies. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products among already approved drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. The information on Japanese guidance and the guidance's Q&As is already provided in our previous paper. In this paper, we examined the US guideline published in 1995 and compared with the Japanese guideline, which will give a useful information to make a guidance on bioequivalence studies of topical drug products in Korea.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.27 no.2
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• pp.64-74
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• 2014

Objective : The purpose of this study is to report the effectiveness of a Korean Medicine Treatment on 45 facial atopic dermatitis patients. Methods : Total 45 facial atopic dermatitis patients, who has visited korean medical clinic in year 2011 were analyzed by Objective SCORAD Index(OSI) and Investigator's Global Assessment(IGA). Subanalysis of OSI and IGA were done according to topical ointment user/non-user, treatment period and change in IGA distribution. Results : 1. Male and female percent was 20%:80%. 17.8% were teens, 55.6% were twenties, 13.3% were thirties, 13.3% were above age forty. 64.4% were on topical ointment treatment of corticosteroid or calcineurin inhibitor, and 35.6% were not at the initial visit. Patients with family history were 44.4% and 62.2% had atopic dermatitis past history. 2. OSI and IGA were significantly lower after 1~3, 3~6, 6~9 month of treatment. Average post-treatment score was lower in longer-treated group. 3. IGA distribution has changed from average 3.42 at the first visit to 1.76 at final visit. 91.1% of total patients reported decrease in IGA at the final visit. 4. OSI and IGA improvement rate were significantly higher in non-topical ointment user than the user. Age, treatment period, initial OSI and IGA score difference were not significantly different. Conclusion : A significant percent of 45 facial atopic dermatitis patients who were treated with Korean Medicine Treatment reported decrease in OSI and IGA. The difference increased with the treatment period. Non-topical ointment users' improvement was significantly higher than topical ointment user.

• The Journal of Korean Physical Therapy
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• v.16 no.1
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• pp.70-84
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• 2004

This study was carried out to evaluate the body fat breakdown during topical seaweed extract treatment and in combination with the iontophoresis, phonophoresis method to enhance skin absorption of lipolytic compounds. Of 24 female obesity subjects, 7 treated a gel types of seaweed extract only(control group) and 10 treated in combination with the iontophoresis(experimental group I) and 7 treated in combination with the phonophoresis(experimental group II). Topical treatment of each sample was designed for 2 weeks, treated with 2 times a day about $10m{\ell}$ on the abdomen, triceps, thigh and superior ilium, respectively. Experimental group treat with the iontophoresis and phonophoresis during 5 minutes immediately after topical treatment. After one and two weeks of topical treatment, measured body weight, body fat, skinfolds thickness respectively. Then venous blood samples were taken and analyzed serum lipids. The results were as follows; 1) There were decrement of body weight, $\%$ of body fat, superior ilium, triceps and thigh thickness between pre and post treatment in all group. Especially, there were more decrement of body weight, $\%$ of body fat in the iontophoresis treated group. 2) There were decrement in total CHOL, LDL, TRIG and increment in HDL in all group. These phenomena were predominant in the iontophoresis treated group. CHOL decrement in the experimental group were significant after two weeks iontophoresis treatment.

• Journal of Dental Anesthesia and Pain Medicine
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• v.20 no.6
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• pp.337-356
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• 2020

This systematic review focused on the efficacy of topical products in reducing temporomandibular joint disorder (TMD)-associated pain, in comparison to placebo or control interventions. The EMBASE, Web of Science, Cochrane Library, and MEDLINE via PubMed databases were searched for randomized controlled trials (RCTs) using topical interventions in adults diagnosed with TMD. The pain intensity was the primary outcome, and other clinical findings were the secondary outcomes. The risk of bias was evaluated according to the Cochrane's handbook. The search up to February 7, 2020 identified a total of 496 unduplicated references. Nine RCTs with 355 adult patients diagnosed with TMD were included. The meta-analysis did not show a significant reduction in baseline pain intensity in the nonsteroidal anti-inflammatory drug (NSAIDs) group, when compared to the placebo group (P = 0.288). One study demonstrated a statistically significant pain score decrease for Theraflex-TMJ compared to placebo after 10 d of treatment (P = 0.003) and follow-up, 5 d after the last application (P = 0.027). Ping On reduced pain at 4 weeks of application (P < 0.001) but not after 7 d of application (P = 0.136). In one study, cannabidiol (CBD) significantly improved the pain intensity compared to placebo (P < 0.001). However, no differences were found with capsaicin in the two studies (P = 0.465). Evidence was of low quality because the studies were considered as having an unclear or a high risk of bias and a small number of studies were analyzed. The evidence is not sufficient to support the use of topical NSAIDs and capsaicin, and limited evidence was found for Threraflex-TMJ, bee venom, Ping On, and CBD, with only one study reporting for each. Additional studies are recommended to validate these results.

• Journal of Dental Anesthesia and Pain Medicine
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• v.21 no.4
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• pp.329-336
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• 2021

Background: In the field of dentistry, topical anesthetics play an important role in reducing pain during needle pricks. The anesthetic property of betel leaves remain unexplored, even though they have been widely used for the treatment of various ailments. The purpose of this study was to compare and evaluate pain perception following topical application of lignocaine gel, clove gel, ice, and newly developed betel leaf extract gel during intraoral injection in children. Methods: Sixty children aged 6-10 years who met the inclusion criteria were divided into four groups. Topical anesthetic agents, 2% lignocaine (Lox-2% Jelly, Neon, Mumbai, India), 4.7% clove gel (Pain Out Dental Gel, Colgate Palmolive India Ltd, Solan, India), 10% betel leaf extract gel, and ice were applied to each group for one min, followed by administration of infiltration anesthesia. Pain perception was analyzed during needle insertion. The Wong Bakers FACES pain rating scale (WBFPRS) was used for subjective assessment and the Sound, Eye, Motor (SEM) scale for objective assessment. Recorded values were tabulated and subjected to appropriate statistical analysis using SPSS software with a P value set at 0.05. Results: The clove oil and betel leaf groups demonstrated the highest WBFPRS scores, followed by the ice and lignocaine groups. The clove, betel leaf extract, and ice groups showed equal and highest SEM scores, followed by the lignocaine group. The mean WBFPRS and mean SEM scores were statistically significant. Conclusion: Betel leaf extract gel is effective in reducing pain and can act as an alternative topical anesthetic agent.

• Journal of Dental Anesthesia and Pain Medicine
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• v.24 no.2
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• pp.91-99
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• 2024

Background: Palatal injections are often painful. We aimed to compare topical ice and 20% benzocaine gel for pre-injection anesthesia before greater palatine nerve block (GPNB) injections. Methods: A randomized split-mouth clinical trial was conducted among patients aged 15-60-years needing bilateral GPNB injections. A total of 120 palatal sites from 60 patients were randomly allocated to Group A (topical ice) or Group B (20% benzocaine gel). Pain was evaluated using sound, eye, motor (SEM), and the visual analog scale (VAS) in both groups. Inferential analysis was performed using the Mann-Whitney U test. Results: The mean age of the participants was 20.5 ± 3.9 years. The median VAS score for group A was 11 (Q1 - Q3: 5.25 - 21.75), which was slightly higher than the 10 (Q1 - Q3: 4.0 - 26.75) reported in group B. However, the difference was not statistically significant (P = 0.955). The median SEM score for group A and group B was 3.5 (Q1 - Q3: 3.0 - 4.0) and 4.0 (Q1 - Q3: 3.0 - 4.0), respectively, which was statistically insignificant (P = 0.869). Conclusion: Using ice as a form of topical anesthetic for achieving pre-injection anesthesia before GPNB was as effective as 20% benzocaine gel.

• Journal of Dental Anesthesia and Pain Medicine
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• v.24 no.2
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• pp.119-128
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• 2024

Background: In pediatric dentistry, fear and anxiety are common among children. Local anesthetics (LA) are widely used to control pain and reduce discomfort in children during dental treatment. Topical anesthetics play a vital role in reducing pain and the unpleasant sensation of a needle puncture in children. Peppermint oil has been extensively used for various diseases. However, its anesthetic properties remain unknown. Peppermint oil, used in mouthwashes, toothpastes, and other topical preparations has analgesic, anesthetic, and antiseptic properties. This study aimed to compare and evaluate pain perception following the topical application of peppermint oil versus lignocaine spray before an intraoral injection in children, aged 8-13 years. Method: Fifty-two children, aged between 8-13 years, who required local anesthesia for dental treatment were divided into two groups of 26 each by simple random sampling (Group 1: 0.2% peppermint oil and Group 2: lignocaine spray). In both groups, physiological measurements (e.g., heart rate) were recorded using pulse oximetry before, during, and after the procedure. Objective pain measurement (Sound Eye Motor (SEM) scale) during administration and subjective measuremeant (Wong-Baker Faces Pain Rating Scale (WBFPRS)) after LA administration were recorded. This was followed by the required treatment of the child. Physiological parameters were compared between the two groups using an independent t-test for intergroup assessment and a paired t-test and repeated-measures ANOVA for intragroup comparisons. The Mann-Whitney U test was used to analyze the pain scores. Results: Intragroup mean heart rates, before, during, and after treatment were statistically significantly different (P < 0.05). However, the intergroup mean pulse rates did not differ significantly between the two groups. The mean WBFPS score in the lignocaine spray group was 4.133 ± 2.06 was statistically different from that of the peppermint oil group (0.933 ± 1.03; P < 0.001^*). The mean SEM score was significantly lower in the peppermint oil group than that in the lignocaine spray group (P = 0.006). No negative effects were observed in this study. Conclusion: 0.2% peppermint oil was effective in reducing pain perception.

• Journal of Photoscience
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• v.9 no.2
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• pp.470-471
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• 2002

It has been well documented that dermal irradiation by ultraviolet A (UVA) locally decreases the number of Langerhans cells and suppresses contact hypersensitivity of the skin. We found that topical irradiation of UVA to the eye systemically decreased the number of Langerhans cells (LC) in the dorsalskin and lymph nodes and elicited lymphocyte apoptosis in the latter tissues but not in the thymus. Optic nerve resection, but not ciliary ganglionectomy, eliminated the UVA-induced decrease in dermal Langerhans cells by a mechanism that was partially inhibited by hypophysectomy. The immunosuppressive effect of UVA was not observed in knockout mice lacking inducible-type of nitric oxide synthase (iNOS). These results suggested that topical irradiation of UVA to the eye induced immunosuppression via NO-dependet neuronal pathways.

• Journal of Ginseng Research
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• v.13 no.2
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• pp.248-253
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• 1989

The effects of 13-cis-retinoic acid and ginseng saponin iron Korean red ginseng on hyperkeratinization of guinea pig skin were investigated by means of enzymatic analysis and light microscopic observation. To induce hyperkeratinization, hexadevance It was topically applied to the dorsal skin of female guinea Pigs every other day for eight days and 13-cis- retinoic acid or ginseng saponin solution was administered orally or topically applied daily during the experimental period. As a result, both topical application of ginseng saponin and oral administration of 13-cis-retinoic acid showed prepentive effects on hyperkeratinization while topical application of 13-cis-retinoic acid inhibited normal epidermal cell proliferation and reduced epidermal enzyme activities such as LDH. ICD and GSPDH below the levels in a normal epidermis. It is suggested that topical application of ginseng saponin and oral administration of 13-cis-retinoic acid may have beneficial efforts against hyperkeratinization possibly by controlling epidermal proliferation and enzyme activities related to epidermal energy metabolism.

• Journal of Chest Surgery
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• v.20 no.3
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• pp.483-488
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• 1987

Phrenic nerve injury has been reported with the use of iced slush for topical cardiac hypothermia. A review of the preoperative and the postoperative chest roentgenograms was performed to detect phrenic nerve injury in patients undergoing cardiac operation with the use of iced slush for topical hypothermia from January, 1985 to June, 1987. The reviewed series included 45 patients who had undergone valve replacement. In this review, the injured site of phrenic nerve was left in 13 cases, right in 1 case and the overall incidence of phrenic nerve paralysis following open heart surgery was 31%. Compared to the incidence of phrenic nerve paralysis in the control group [without pericardial insulation] [406, 12 cases/30 cases], that in the group of patients receiving pericardial insulation [13.3%, 2 cases/15 cases] was lower, but there was no statistical significance. The initial time that diaphragmatic paralysis developed was mean 3.5 days [range 1-8 days] postoperatively and the recovery time of the paralysis was mean 4.7 months [range 0.5-10.5 months] postoperatively.