Treatment of Chronic Spontaneous Urticaria with a Single Dose of Omalizumab: A Study of Four Cases

Background:Chronic spontaneous urticaria (CSU) has a detrimental effect on patients’ emotional and physical quality of life. Omalizumab, an anti-immunoglobulin E humanized monoclonal antibody, has been shown to be very effective in the treatment of refractory chronic urticaria patients but may not be an economically viable option for all CSU patients. However, we present a case series where a single dose of omalizumab gave sustained relief of symptoms in patients with CSU, which may be an economical option.Aims:The aim of this study is to assess the efficacy of a single dose of omalizumab in the treatment of CSU. Materials and Methods: Four patients of CSU whose disease was not controlled with four times the licensed dose of tablet fexofenadine 180 mg were exhibited one subcutaneous injection of omalizumab and were followed up at 4 weekly intervals for 24 weeks for Weekly Urticaria Activity Score 7 (UAS7) and Dermatology Life Quality Index (DLQI).Results:A sharp decline in UAS7 and DLQI was documented in 7–10 days. The decline was maintained up to 16 weeks in one case and 20 weeks in the other three cases. Both the scores at the end of the follow-up period of 24 weeks were better than the pre-omalizumab scores.Conclusion:The results of this case series indicate the efficacy of a single-dose omalizumab in treating moderate to severe refractory CSU. Further studies are required to identify the minimum frequency of administering omalizumab to effectively control CSU. This would greatly reduce the cost of this novel therapy.     

Chronic Idiopathic Urticaria and Thyroid Autoimmunity: Perplexing Association

Background:

Autologous serum skin test (ASST) is the most commonly used laboratory test to differentiate chronic autoimmune urticaria patients from chronic idiopathic urticaria patients without autoantibodies. Thyroid autoimmunity is the original paradigm for autoimmune disease in general and many previous studies show increased prevalence of thyroid autoantibodies and deranged thyroid hormone profile in chronic idiopathic urticaria patients.

Aim:

To find the association between thyroid autoimmunity and chronic autoimmune urticaria, if any.

Materials and Methods:

The chronic idiopathic urticaria patients were divided into two subgroups based on autologous serum skin test. Thyroid autoantibodies were estimated in 40 patients each of ASST positive and ASST negative groups. Further, thyroid hormone profile was done in cases with significant titers of thyroid autoantibodies. Forty patients, who had never suffered from urticaria, represented the control group.

Results:

The prevalence of thyroid autoantibodies did not differ significantly among the ASST positive (20%) and ASST negative patients (15%). The control group had low prevalence of these autoantibodies (5%).

Conclusion:

The almost equal prevalence of thyroid autoantibodies in two subgroups of chronic idiopathic urticaria patients suggests possibly the same etiopathogenesis of the two subgroups. The two subgroups probably form a continuum, or even may be the same entity.     

Autologous Serum Therapy in Chronic Urticaria: A Promising Complement to Antihistamines

Background:

Chronic urticaria (CU) is a vexing problem and patients of CU suffer from the morbidity that arise from irritable itch and weals and are also subjected to a huge antihistamine pill burden. The symptoms are more in autoreactive urticaria (AU) where auto-antibodies in blood flares-up the condition. Search for newer effective modalities which can reduce pill burden is a felt need.

Aims:

This study evaluates the effectiveness of autologous serum therapy (AST) in CU and also determines its usefulness in AU.

Materials and Methods:

Double blind, parallel group, randomized, controlled study. Fifty four patients were given AST and 57 patients were given injection normal saline (placebo), along with cetirizine in an on-demand basis in both groups. AST/Placebo was given weekly for nine weeks and followed-up for a total period of 24 weeks. AU was diagnosed by autologous serum skin test. Urticaria total severity score (TSS), Urticaria activity score (UAS), Dermatologic life quality index (DLQI) was used as primary effectiveness variables. Safety parameters assessed were the spontaneously reported adverse events and laboratory parameters.

Results:

TSS showed significant improvement from baseline, 7^th week and 8^th week onwards in AST group and placebo group respectively. Group comparison showed significant improvement 4^th week onwards. UAS showed similar results. DLQI showed significant improvement in AST group compared to placebo at the end of study. Both AU and non-AU patients showed comparable improvement of TSS.

Conclusion:

AST shows promise in treatment of urticaria regardless of the autoreactive nature.     

依巴斯汀治疗慢性自发性荨麻疹的疗效和安全性

目的观察双倍剂量的依巴斯汀和常规剂量依巴斯汀联合富马酸酮替芬片治疗慢性自发性荨麻疹的疗效和安全性。方法将受试者随机分为两组,治疗组予双倍剂量的依巴斯汀,对照组予常规剂量的依巴斯汀联合富马酸酮替芬片,观察两组的疗效和安全性,并进行统计学分析。结果治疗2周后治疗组和对照组有效率分别为90．00％和75．00％;4周后分别为93．33％和80．77％,疗效差异有统计学意义（P〈0．05）。两组均未出现严重不良反应。结论双倍剂量的依巴斯汀治疗慢性自发性荨麻疹效果显著,不良反应轻,安全性高,值得临床应用。     

Updosing of Nonsedating Anti-histamines in Recalcitrant Chronic Urticaria

Chronic urticaria (CU) is a persistent, debiliating condition that causes severe impairment on the quality of life (QoL) of patient by interrupting work productivity. Current guidelines recommend second-generation (nonsedating) anti-histamines for the treatment for all forms of urticaria. In patients who do not respond adequately to conventional doses of anti-histamines, it is recommended to increase the dose to up to four times to obtain control. But there are only few controlled studies that have assessed the efficacy and safety of nonsedating anti-histamines. Though sedating histamines are frequently used as an add-on therapy in severe cases, they have a negative impact on QoL by compromising sleep and performance. The use of other suggested therapeutic options (omalizumab, cyclosporine A, montelukast and dapsone) is also limited by paucity of data on their efficacy and adverse effect profile. Second-generation anti-histamines which are relatively safer require more proven data to support their judicious use to improve disease in patients with CU.     

Treatment of Refractory Chronic Urticaria

Chronic spontaneous urticaria is a distressing disease encountered frequently in clinical practice. The current mainstay of therapy is the use of second-generation, non-sedating antihistamines. However, in patients who do not respond satisfactorily to these agents, a variety of other drugs are used. This article examines the available literature for frequently used agents including systemic corticosteroids, leukotriene receptor antagonists, dapsone, sulfasalazine, hydroxychloroquine, H2 antagonists, methotrexate, cyclosporine A, omalizumab, autologous serum therapy, and mycophenolate mofetil, with an additional focus on publications in Indian literature.     

Role of Nasal Carriage of Staphylococcus aureus in Chronic Urticaria

Aim:

To evaluate the role of nasal carriage of Staphylococcus aureus in patients suffering from chronic urticaria.

Method:

All total 82 patients were included for this study. Study group comprised 57 patients with chronic urticaria and the control group comprised 25 healthy volunteers. Nasal swab specimens were taken from all the 82 patients for bacterial culture and antimicrobial sensitivity. Patients with chronic urticaria who had positive growth for S. aureus were treated with sensitive antimicrobial agent. Nasal swab specimens were taken again from all the patients who received antimicrobial therapy to ensure complete eradication of S. aureus. All patients were followed up for a period of 6 weeks after the treatment. Urticarial activity was measured with the help of urticarial activity score.

Results:

S. aureus was detected in swab specimens from the nasal cavity in 32 patients in the study group and 7 patients in the control group. In the study group, after the antimicrobial treatment, 9 patients (28.12%) had complete recovery from urticaria during the follow-up period; 4 patients (12.5%) showed partial recovery from urticaria while the remaining patients (59.37%) continued to suffer from urticaria.

Conclusion:

This study showed that nasal carriage of S. aureus can act as an etiological factor in chronic urticaria.     

Kojic Acid vis-a-vis its Combinations with Hydroquinone and Betamethasone Valerate in Melasma: A Randomized,Single Blind,Comparative Study of Efficacy and Safety

Background:

Melasma is a relatively common, acquired symmetric hypermelanosis characterized by irregular light to gray-brown macules involving sun-exposed areas. Kojic acid, with its depigmenting potential due to tyrosinase inhibition and suppression of melanogenesis, has become a vital component of the dermatologists’ armamentarium against melasma.

Aim:

To study and compare the efficacy of kojic acid 1% alone, vis-a-vis its separate combinations with 2% hydroquinone or 0.1% betamethasone valerate and a combination of all these three agents with respect to the duration of symptoms and level of pigmentation in the therapy of melasma.

Materials and Methods:

Eighty patients from a single tertiary care center objectively assessed by calculating the melasma area severity index (MASI) and randomized (simple randomization) into four parallel groups (A, B, C, and D) of 20 each were prescribed once daily local application at night, (participants blinded regarding the difference in identity of interventions), as follows:Group A – kojic acid 1% cream.Group B – kojic acid 1% and hydroquinone 2% cream.Group C – kojic acid 1% and betamethasone valerate 0.1% cream.Group D – kojic acid 1%, hydroquinone 2%, and betamethasone valerate 0.1% cream.Strict photoprotection and use of a SPF 15 sunscreen was advised during the day. Patients were evaluated every 2 weeks and a fall in MASI score was calculated at the end of the study period of 12 weeks by the same investigator.

Results:

The response was compared according to percentage decrease in MASI score. Efficacy was evaluated among the groups at the end of 3 months using bivariate analysis and calculated by using the paired ‘t’ test. The clinical efficacy of group B was the highest followed closely by group D and group A, that of group C being the lowest.

Conclusion:

Kojic acid in synergy with hydroquinone is a superior depigmenting agent as compared with other combinations.     

咪唑斯汀治疗慢性荨麻疹的随机双盲研究

目的 评价咪唑斯汀治疗慢性荨麻疹的疗效和安全性,并与氯雷他定进行比较。方法 多中心、随机双盲、平行对照临床试验。结果 5个研究中心共入选慢性荨麻疹患者213例,纳入疗效分析共206例,其中咪唑斯汀组104例,氯雷他定组102例。治疗结束时,咪唑斯汀组总有效率(痊愈+显效)为80.8%,氯雷他定组为74.5%,两组差异无显著性(χ²=1.16,P=0.28)。咪唑斯汀组于治疗后第1周时,对控制风团大小、每周发作次数及直观模拟标尺法(VAS)瘙痒程度平均值明显优于对照组,两组差异均有显著性(P=0.05,P=0.03和P=0.02)。至第2、4周时,两组间比较差异无显著性(P>0.05)。咪唑斯汀组不良事件发生率为28.6%,对照组为25.5%,差异无显著性(χ²=0.25,P=0.62)。结论 口服咪唑斯汀或氯雷他定10mg/d治疗慢性荨麻疹疗效相似,但咪唑斯汀似乎比氯雷他定组起效更快,两组不良事件发生率及表现无明显差异。     

A Comparative Randomized Open Label Study to Evaluate Efficacy,Safety and Cost Effectiveness Between Topical 2% Sertaconazole and Topical 1% Butenafine in Tinea Infections of Skin

Background:

Dermatophytoses are the superficial fungal infections of skin, hair, and nail. Butenafine is a benzylamine group of antifungal that inhibits the biosynthesis of ergosterol by blocking squalene epoxidase. Sertaconazole is a newer imidazole antifungal which inhibits the biosynthesis of ergosterol by inhibiting 14-α lanosterol demethylase. The study was done to compare a newer antifungal with a relatively older one.

Aim:

To compare the efficacy, safety and cost effectiveness of topical 2% sertaconazole cream and 1% butenafine in tinea infections of skin.

Materials and Methods:

Patients were randomly allocated to two treatment groups. They were advised to apply the drug topically twice a day for one month on the lesions. They were followed up at an interval of 10 days. Clinical score and Global Evaluation Response were assessed at baseline and during each follow up.

Results:

A total 125 patients were recruited, out of them 111 completed the whole study. Median Sign and Symptom Score of tinea on the baseline was 9 [5,9] that was reduced to 0 [0,4] by 2% sertaconazole while it was 9 [6,9] in the butenafine group on the baseline that was reduced to 0 [0,6] at the end of the treatment. 98% and 90% of the patients got complete clearance of the lesions with butenafine and sertaconazole, respectively. Treatment with butenafine was more cost effective as compared to sertaconazole.

Conclusion:

1% butenafine is more efficacious, cost effective, and equally safe as compared to 2% sertaconazole in the tinea infections of skin.     

Allergic Urticaria: A Case Report of Rare Skin Allergy with a Common Mouthwash

Chlorhexidine is a widely used antiseptic and disinfectant in medical and non-medical environments. Compared to its ubiquitous use, allergic contact dermatitis from chlorhexidine has rarely been reported and so its sensitization rate seems to be low. Chlorhexidine has been used for more than 50 years but it was only in the last two decades, that reports of immediate- type reactions to chlorhexidine were seen. Reactions ranging from localized urticaria to anaphylactic shock and hypersensitivity reactions, including delayed hypersensitivity reactions such as contact dermatitis, fixed drug eruptions, and photosensitivity reactions, began to appear more frequently. However the prevalence of contact urticaria and anaphylaxis due to chlorhexidine remains to be unknown. In this case report we have reported a case of urticaria due to oral use of chlorhexidine. The adverse reaction was confirmed by a skin prick test.     

Skin Prick Test in Patients with Chronic Allergic Skin Disorders

Background:

Chronic allergic skin disorders are the inflammatory and proliferative conditions in which both genetic and environmental factors play important roles. Chronic idiopathic urticaria (CIU) and atopic dermatitis (AD) are among the most common chronic allergic skin disorders. These can be provoked by various food and aeroallergens. Skin prick tests (SPTs) represent the cheapest and most effective method to diagnose type I hypersensitivity. Positive skin tests with a history suggestive of clinical sensitivity strongly incriminate the allergen as a contributor to the disease process.

Aims and Objectives:

To determine the incidence of positive SPT in patients with chronic allergic skin disorders and to identify the various allergens implicated in positive SPT.

Methods:

Fifty patients of chronic allergic disorders were recruited in this study. They were evaluated by SPT with both food and aeroallergens.

Results:

In our study, SPT positivity in patients of CIU was 63.41% and in AD was 77.78%. Out of the 41 patients of CIU, the most common allergen groups showing SPT positivity were dust and pollen, each comprising 26.83% patients. SPT reaction was positive with food items (21.6%), insects (17.07%), fungus (12.20%), and Dermatophagoides farinae, that is, house dust mite (HDM) (7.32%). The allergen which showed maximum positivity was grain dust wheat (19.51%). Among nine patients of AD, maximum SPT positivity was seen with Dermatophagoides farinae, pollen Amaranthus spinosus, grain dust wheat, and cotton mill dust; each comprising 22.22% of patients.

Conclusion:

Our study showed that a significant number of patients of CIU and AD showed sensitivity to dust, pollen, insects, Dermatophagoides farinae, and fungi on SPT. Thus, it is an important tool in the diagnosis of CIU and AD.     

Oral Ketotifen and Topical Antibiotic Therapy in the Management of Pruritus in Prurigo Nodularis: A Randomized,Controlled, Single-Blind,Parallel Study

Aims:

To evaluate the role of oral ketotifen and topical antibiotic therapy in the management of pruritus in prurigo nodularis (PN) patients.

Materials and Methods:

Twenty-seven patients with PN and a history of atopy with raised IgE were included in this study in a dermatology clinic. All patients had positive growth of Staphylococcus aureus on the lesional skin swab. All patients received topical halobetasol and oral hydroxyzine for 4 weeks. In addition, all patients in the study group received oral ketotifen and topical antibiotic therapy for 4 weeks. Randomization was performed by using a table of random numbers, and the participants were randomly allocated to one of the two groups in the study. The study was a single-blind study, and the blinding was done by the investigator.

Results:

Of the 14 patients in the study group, 9 had complete relief from pruritus by the end of first week, which was maintained till the end of 4 weeks. In the control group, mild to moderate reduction in the intensity of pruritus in the PN lesions of all patients were noted by the end of the first week. No further improvement in the level of pruritus was noted in the participants during the trial period. The treatment was well tolerated by the patients, and the adverse reactions of drugs were minimal in both groups.

Conclusions:

This study showed that oral ketotifen and topical antibiotic therapy can be helpful in the management of pruritus in PN patients.     

慢性自发性荨麻疹患者血清IL-17、IL-23水平的检测及意义

目的:探讨白细胞介素-17(Interlenkin-17,IL-17)、白细胞介素-23(Interleukin-23,IL-23)在慢性自发性荨麻疹患者中的表达及意义。方法:选取慢性自发性荨麻疹患者和健康献血者各30例,用酶联免疫吸附法检测血清中IL-17、IL-23水平,并分析它们与病情、病程之间的关系。结果:慢性自发性荨麻疹患者的血清IL-17水平[(19.3±8.1)pg/mL]、IL-23水平[(28.9±11.1)pg/mL]均高于对照组[(8.6±5.7)pg/mL,(10.9±6.2)pg/mL],组间比较差异有统计学意义(t值分别为5.92、7.72,P值均<0.01)。慢性自发性荨麻疹患者IL-17、IL-23与症状评分呈正相关关系(r=0.89、r=0.75,P值均<0.01),与病程无明显相关性(r=0.23、r=0.24,P值均>0.05),IL-17与IL-23呈正相关关系(r=0.81,P<0.01)。结论:IL-17、IL-23在慢性自发性荨麻疹发病机理中可能起着重要作用。     

Efficacy and Safety of Terbinafine Hydrochloride 1% Cream vs. Sertaconazole Nitrate 2% Cream in Tinea Corporis and Tinea Cruris: A Comparative Therapeutic Trial

Context:

To the best of our knowledge, till date no study comparing the efficacy and safety of terbinafine hydrochloride 1% cream and sertaconazole nitrate 2% cream has been done in localized tinea corporis and tinea cruris.

Aims:

This clinical trial was carried out to study and compare the efficacy of topical terbinafine hydrochloride 1% cream and sertaconazole nitrate 2% cream in localized tinea corporis and tinea cruris and to know the adverse effects of these antifungal creams.

Settings and Design:

In this prospective, single blind, randomized control trial with two arms, patient were randomized into two groups Group A (treatment with terbinafine cream) and Group B (treatment with sertaconazole cream). A total of 38 patients were enrolled for the study, 20 patients in group A and 18 patients in group B. But five patients of group A and three patients of group B were lost for follow-ups. Therefore sample size was of 30 patients with 15 patients in group A and group B each.

Materials and Methods:

Patients in group A and B were treated with twice daily topical 1% terbinafine hydrochloride and 2% sertaconazole nitrate cream respectively for a total duration of three weeks. Clinical improvement in signs and symptoms of each clinical parameter, namely itching, erythema, papules, pustules, vesicles, and scaling were graded weekly and clinical cure was assessed. KOH mount and culture was done weekly up to 3 weeks to access mycological cure. Fungal culture was done on Sabouraud''s dextrose agar with chloramphenicol and cycloheximide.

Statistical Analysis Used:

Statistical analysis was done using students paired and unpaired t-tests from the data obtained.

Results:

Comparison between Group A and Group B for complete cure (clinical and mycological) showed that at the end of 3 weeks both terbinafine and sertaconazole groups had 100% complete cure. When the two groups were compared for complete cure, at the end of 1^st and 2^nd week, statistically non-significant results were observed (P = 0.461 and P = 0.679 respectively). However, at the end of 2^nd week, complete cure rate for terbinafine was 80% as compared to 73.35% for sertaconazole with no statistical significance. In both Group A and Group B, clinically significant local side effects like erythema, swelling, stinging sensation, or increased itching were not noticed. A majority of our patients in both the group showed Trichophyton rubrum followed by Trichophyton mentagrophytes growth on culture. In Group A, 11 patients showed growth of T. rubrum, 2 patients showed growth of T. mentagrophytes, and 1 patient had only KOH test positive. In Group B, 10 patients revealed growth of T. rubrum, followed by growth of T. mentagrophytes in 3 and Microsporum canis in 2 patients. The therapeutic response is more or less same in infection with different species.

Conclusions:

The newer fungistatic drug sertaconazole nitrate 2% cream was as effective as terbinafine hydrochloride 1% cream which is one of the fungicidal drugs, though terbinafine hydrochloride 1% cream has higher rates of complete cure at the end of 2 weeks as compared to sertaconazole nitrate 2% cream. Both the drugs showed good tolerability with no adverse effects.     

地洛他定和氯雷他定治疗慢性特发性荨麻疹多中心双盲对照临床试验

目的　观察地洛他定治疗慢性特发性荨麻疹效果及安全性。方法　采用多中心、双盲、双模拟阳性对照研究 ,随机分为试验组和对照组。地洛他定 5mg/次 ,氯雷他定 10mg/次 ,均 1次 /d ,连续服用 2 8天 ,分别于用药后第 1、2、4周随访 ,观察疗效和不良反应。结果　入组例数 2 17例 ,可评价疗效及安全性例数分别为 2 11例和 2 12例。试验组和对照组服药后第 1周疗效分别为 2 3 .81%和 3 2 .0 8% ,第 2周分别为 62 .86%和 5 9.43 % ,第 4周疗效分别为 88.78%和83 .0 2 %。两组不良反应发生率分别为 11.3 2 %和 13 .2 1% ,主要有口干、嗜睡、头痛等。结论　地洛他定治疗慢性特发性荨麻疹安全有效。     

Clinical and Investigative Assessment of Patients with Positive Versus Negative Autologous Serum Skin Test: A Study of 80 South Indian Patients

Background:

Chronic urticaria (CU) is defined as urticaria persisting daily as or almost daily for more than 6 weeks and affecting 0.1% of the population. Mast cell degranulation and histamine release is of central importance in the pathogenesis of CU. About 40-50% of the patients with chronic idiopathic urticaria demonstrate an immediate wheal and flare response to intra-dermal injected autologous serum. This led to the concept of autoimmune urticaria.

Aims:

To determine the occurrence, clinical features, associated clinical conditions, comorbidities of autoimmune urticaria and to compare this with chronic spontaneous urticaria. This study aimed to find the frequency of autologous serum skin test (ASST) positive patients among patients with CU and to identify the clinical and laboratory parameters associated with positive ASST.

Materials and Methods:

Prospective correlation study was done on 80 chronic urticaria patients, more than 6 weeks duration, attending outpatient department of dermatology during a period of November 2007 to January 2010. Patients were subjected to ASST, complete blood count, urine routine examination, liver function tests, renal function tests, thyroid function tests, H. pylori antibody tests, C3 and C4 complement level estimation, antinuclear antibody, and urine analysis.

Results:

ASST was positive in 58.75% and negative in 41.25% of the patients, respectively. Out of 33 patients with history of angioedema, 9 (27.3%) patients were in ASST negative group and 24 were in positive group, this was statistically significant. Both groups showed no statistically significant difference for epidemiological details.

Conclusion:

ASST is considered a screening test for an autoimmune urticaria, which decreases the rate of diagnosis of “idiopathic” form of chronic urticaria. Patients with an autoimmune urticaria have more severe urticaria, more prolonged duration, more frequent attacks, and angioedema. Identification of autoimmune urticaria may permit the use of an immunotherapy in severe disease unresponsive to anti-histamine therapy.     

左西替利嗪与西替利嗪治疗慢性荨麻疹多中心随机双盲对照研究

目的 研究和比较左西替利嗪和西替利嗪治疗慢性荨麻疹的疗效和安全性.方法 选择慢性荨麻疹患者为研究对象,采用多中心、随机、双盲、对照临床研究.试验组盐酸左西替利嗪片每日1次,每次5mg,对照组盐酸西替利嗪片每日1次,每次10mg,均连续服用28d.分别于用药后第7、14、28天随访,观察疗效和不良反应.结果 入选病例132例,可评价疗效和安全性病例均为130例.ITT分析左西替利嗪组治疗后第7、14、28天有效率分别为73.44%、82.81%、89.06%,西替利嗪组有效率分别为77.27%、81.82%、81.82%,两组比较差异无显著性.左西替利嗪组和西替利嗪组不良反应发生率分别为14.06%和18.18%,主要有口干、嗜睡.结论 左西替利嗪治疗慢性荨麻疹安全有效.     

An Open Label Prospective Randomized Trial to Compare the Efficacy of Coal Tar-Salicylic Acid Ointment Versus Calcipotriol/Betamethasone Dipropionate Ointment in the Treatment of Limited Chronic Plaque Psoriasis

Background:Chronic plaque psoriasis is a common papulosquamous skin disorder, for which a number of topical agents are being used including coal tar, topical steroids and more recently topical calcipotriol/betamethasone dipropionate. There is no study comparing purified coal tar preparation with calcipotriol/betamethasone dipropionate ointment in limited chronic plaque psoriasis.Results:Mean PASI was significantly lower at week 2 (P = 0.01) and week 4 follow-up (P = 0.05) and the mean reduction in PASI was significantly higher at week 2 (P = 0.02) with calcipotriol/betamethasone than coal tar-salicylic acid, but this difference was not sustained at subsequent follow-up visits. Similarly, PGA scores at weeks 2 and 4 were significantly lower with calcipotriol/betamethasone dipropionate ointment (P = 0.003 and P = 0.007 respectively). There was no significant difference in any parameter during subsequent follow-up visits or at the end of the treatment phase (12 weeks).Conclusion:Topical nightly application of calcipotriol/betamethasone dipropionate ointment leads to an initial, more rapid reduction in disease severity, but the overall outcome parameters are comparable in the two treatment groups.     

Comparative Assessment of the Efficacy and Safety of Sertaconazole (2%) Cream Versus Terbinafine Cream (1%) Versus Luliconazole (1%) Cream In Patients with Dermatophytoses: A Pilot Study

Background:

Sertaconazole is a new, broad spectrum, fungicidal and fungistatic imidazole with added antipruritic and anti-inflammatory activity that would provide greater symptomatic relief and hence would be beneficial in improving the quality of life for the patient with dermatophytoses.

Aims and Objectives:

To compare efficacy and safety of sertaconazole, terbinafine and luliconazole in patients with dermatophytoses.

Materials and Methods:

83 patients with tinea corporis and tinea cruris infections were enrolled in this multicentre, randomized, open label parallel study. The initial ‘Treatment Phase’ involved three groups receiving either sertaconazole 2% cream applied topically twice daily for four weeks, terbinafine 1% cream once daily for two weeks, luliconazole 1% cream once daily for two weeks. At the end of treatment phase, there was a ‘Follow-up Phase’ at end of 2 weeks, where the patients were assessed clinically and mycologically for relapse.

Results:

Of the 83 patients, 62 completed the study, sertaconazole (n = 20), terbinafine (n = 22) and luliconazole (n = 20). The primary efficacy variables including change in pruritus, erythema, vesicle, desquamation and mycological cure were significantly improved in all the three groups, as compared to baseline, in the Treatment and Follow-up phase. Greater proportion of patients in sertaconazole group (85%) showed resolution of pruritus as compared to terbinafine (54.6%); and luliconazole (70%), (P < 0.05 sertaconazole vs terbinafine). There was a greater reduction in mean total composite score (pruritus, erythema, vesicle and desquamation) in sertaconazole group (97.1%) as compared to terbinafine (91.2%) and luliconazole (92.9%). All groups showed equal negative mycological assessment without any relapses. All three study drugs were well tolerated. Only one patient in sertaconazole group withdrew from the study due to suspected allergic contact dermatitis.

Conclusion:

Sertaconazole was better than terbinafine and luliconazole in relieving signs and symptoms during study and follow up period. At the end of ‘Treatment Phase’ and ‘Follow-up’ Phase, all patients showed negative mycological assessment in all three treatment groups suggesting no recurrence of the disease.