Comparative evaluation of effectivity and safety of topical amorolfine and clotrimazole in the treatment of tinea corporis

Background:

Tinea corporis is a common superficial dermatophytosis seen in tropical countries. Newer molecules are constantly being introduced for its treatment. Topical clotrimazole is in vogue as the treatment for this condition for a long time. Amorolfine is a comparatively recently introduced drug for topical use in this condition.

Aims:

To assess the effectivity and safety of amorolfine 0.25% cream in patients with tinea corporis, in comparison to clotrimazole 1% cream.

Materials and Methods:

Patients presenting with symptoms of tinea corporis were mycologically confirmed for the presence of fungal hyphae. They were randomly divided into two groups: one group received amorolfine and the other received clotrimazole. Treatment duration was for 4 weeks and study duration was for 8 weeks. Evaluation was carried out using the standard clinical parameters on day 1, day 14, day 28 and a follow-up on day 56. Adverse effects were also recorded. Data entry was done in Excel datasheet and analyzed with Epiinfo 2002. Chi-square test and t-test were used according to the type of data.

Results:

The patients of the two groups were matched at baseline in respect to their demographic profile. Analysis of collected data showed significant improvement in both the groups, suggesting that both the drugs were effective agents in tinea corporis infection. Between-groups comparison of mycological cure rate and clinical improvement showed no significant difference.

Conclusion:

Amorolfine 0.25% cream is found to be safe and effective, like clotrimazole, when used topically in tinea corporis.     

Successful Treatment of Giant Basal Cell Carcinoma with Topical Imiquimod 5% Cream with Long Term Follow-up

The use of the topical Imiquimod 5% cream offers a noninvasive, nonsurgical, and an effective option for the treatment of primary small (<2 cm) superficial basal cell carcinoma (sBCC). However, reports about successful treatment of giant (>5 cm) BCC with topical Imiquimod 5% cream are rare. We present our experience in the treatment of two giant tumors (6 × 8 cm², 5.2 × 4.2 cm²) of BCC on the face with Imiquimod 5% cream, 2 to 3 days/week for 12 weeks. Both the tumors were cured with clinical and pathological evidence, one with 6-year follow-up and the other with 3.5-year follow-up.     

Glycolic Acid Peels/Azelaic Acid 20% Cream Combination and Low Potency Triple Combination Lead to Similar Reduction in Melasma Severity in Ethnic Skin: Results of a Randomized Controlled Study

Background:

Numerous therapeutic options have been tried in the management of melasma.

Aims and Objectives:

This prospective randomized study was planned to assess the efficacy of low potency triple combination (TC) cream (TC-hydroquinone 2%/tretinoin 0.05%/fluocinolone 0.01%) versus glycolic acid (GA) peels/azelaic acid (AA) 20% cream (GA/AA) combination in melasma.

Materials and Methods:

Forty patients with melasma were recruited into this study and randomized into two groups. Group A consisting 20 patients received TC cream once a day for night time application for 3 months. Group B comprising of 20 patients received GA/AA 20% cream combination for 3 months. The disease severity was monitored with digital photography, melasma area and severity index (MASI) score, which was calculated at baseline, 6 weeks and 12 weeks, and visual analog scale (VAS) score, which was calculated at baseline and 12 weeks.

Results:

Of 40 patients, 38 were completed the study. A significant reduction in MASI and VAS was recorded after 6 weeks and 12 weeks of treatment in both groups A and B (P = 0.001). However, there was no significant difference in the mean MASI scores between the two groups at baseline, 6 weeks and 12 weeks. Similarly, there was no difference in the mean VAS scores between the two groups at baseline and 12 weeks. Four patients in group A and 3 in group B experienced adverse effects such as irritation, dryness, and photosensitivity.

Conclusion:

Both low potency TC cream and GA/AA 20% cream combination are effective in treating melasma among Indian patients.     

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.     

Evaluation of topical 0.1% tazarotene cream in the treatment of palmoplantar psoriasis: an observer-blinded randomized controlled study

Background:

Palmoplantar psoriasis is a frequently encountered variant of psoriasis. It is difficult to treat and even more difficult to maintain remission as it is exacerbated by friction and trauma of the patient''s daily activities. Existing topical modalities of treatment are often inadequate and show unpredictable response.

Aim:

To study the efficacy and safety of a newer retinoid, tazarotene, as 0.1% cream in the treatment of palmoplantar psoriasis.

Materials and Methods:

Thirty adult patients with palmo-plantar psoriasis were randomized to therapy with once daily application of topical tazarotene cream (0.1%) or once daily application of clobetasol propionate cream (0.05%) for 12 weeks. The patients were assessed every 2 weeks for improvement in Erythema, Scaling, Fissures and Induration (ESFI) score and Physicians Global Assessment Scale.

Results:

At 12 weeks, the tazarotene group showed mean ESFI reduction to 1.12 (83.2%) from 6.65 at baseline. Complete clearance was noted in 52.9% of the patients. Clobetasol propionate group showed mean ESFI reduction to 0.62 (89.1%) from 5.69 at baseline, with complete clearance in 61.5% of the patients. Differences between the two groups were statistically insignificant. Side effects observed were initial irritation (41%) in the tazarotene group and hypopigmentation (53.8%) in the steroid-treated patients.

Conclusion:

Tazarotene is as effective as clobetasol propionate and provides a good alternative for the treatment of palmo-plantar psoriasis where hypopigmentation limits the use of clobetasol propionate cream.     

Successful treatment of actinic keratosis with imiquimod cream 5%: a report of six cases

BACKGROUND: Actinic keratoses (AK) are premalignant lesions, which are routinely treated by destructive procedures such as cryotherapy, electrodessication or topical 5-fluorouracil. OBJECTIVES: The aim of this study is to report six cases of AK treated with a potential new topical therapy, imiquimod. METHODS: Subjects included in this study had suffered with recurrent AK for between 5 and 16 years. All six men were treated with imiquimod 5% cream three times a week for 6-8 weeks. In the event of a local skin reaction treatment was modified to two times per week. RESULTS: All the AK lesions were successfully cleared after treatment with imiquimod cream 5% for 6-8 weeks. Histologically, no apparent signs of persisting AK could be detected, and no recurrences were reported during follow up. CONCLUSIONS: This study suggests that imiquimod may be useful as a new therapy for the treatment of actinic keratoses.     

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.     

国产5％咪喹莫特乳膏治疗生殖器疣荟萃分析

目的：以循证医学的方法对国产5％咪喹莫特乳膏治疗生殖器疣的疗效、安全性以及预防生殖器疣复发的效果进行系统性评价。方法：检索中文科技期刊数据库（CNKI）、中国生物医学文献数据库（CBMDisc），由两名评价者独立提取资料并进行方法学质量评估。试验数据的统计分析采用Co-chrane协作网提供的RevMan4．2．8软件进行。结果：咪喹莫特乳膏单疗组，最终纳入8个临床随机对照试验，Meta分析结果显示，与安慰剂比较，疗效差异有统计学意义；与2．5％氟尿嘧啶软膏比较，疗效差异没有统计学意义。没有严重系统性不良反应的报道。咪喹莫特乳膏联合物理治疗组，最终纳入12个临床随机对照试验，Meta分析结果显示，以观察3个月或6个月没有在原位复发作为痊愈标准，与安慰剂组比较，疗效差异有统计学意义。结论：现有临床证据表明，国产5％咪喹莫特乳膏治疗生殖器疣有确切的疗效和较好的安全性，对预防生殖器疣复发也有确切的疗效。     

5%咪喹莫特乳膏预防尖锐湿疣复发的疗效观察

目的观察局部外用5%咪喹莫特乳膏在物理治疗尖锐湿疣后预防复发的疗效。方法46例符合尖锐湿疣诊断的病人随机分成治疗组和对照组,均行物理治疗去除疣体后,治疗组外用咪喹莫特乳膏每周3次,对照组外用重组人干扰素α-2b凝胶4次/d。疗程均为12周。结果治疗组和对照组复发率分别为13.6%,42.9%,二者差异有显著性。结论外用咪喹莫特乳膏疗效更佳,能预防CA复发。     

Extramammary Paget's disease treated with topical imiquimod 5% cream

Extramammary Paget's disease (EMPD) is a rare cutaneous, intraepithelial adenocarcinoma usually found in the apocrine gland bearing areas. It is traditionally treated with surgery but has a high rate of recurrence. Of late, topical imiquimod 5% cream has come into use as another treatment option. We present two cases of EMPD in Asian skin treated successfully with topical imiquimod 5% cream.     

Successful treatment of multiple actinic keratoses in organ transplant patients with topical 5% imiquimod: a report of six cases

BACKGROUND: Nonmelanoma skin cancer represents a significant cause of morbidity in organ transplant recipients (OTRs). Cutaneous malignancies, mainly invasive squamous cell carcinoma and its precursor actinic keratosis (AK), appear approximately 5-10 years after organ transplantation. Impaired wound healing and high recurrence rates in immunocompromised patients treated with destructive therapies such as cryosurgery or topical 5-fluorouracil represent frequently known complications. OBJECTIVES: To evaluate the safety and efficacy of imiqimod 5% in the treatment of AKs in OTRs. METHODS: Six OTRs (two kidney, two heart, one lung and one liver) with extensive AKs were treated with imiquimod 5% cream two to three times weekly in an open-label uncontrolled, nonrandomized pilot study. RESULTS: In five of six patients treated with imiquimod 5% cream all AK lesions were cleared after 12-16 weeks. One patient showed partial response. Local adverse events at the site of application included erythema, oedema and mild erosion. No wound infection or scarring was observed in any of these patients. All graft-related laboratory parameters were stable during and after treatment. Immunosuppressive therapy remained unchanged throughout the treatment. CONCLUSIONS: These results suggest that imiquimod 5% cream may be useful for the local treatment of precancerous AK lesions in OTRs.     

PIGMENTED BASAL CELL CARCINOMA SUCCESSFULLY TREATED WITH 5% IMIQUIMOD CREAM

Basal cell carcinoma (BCC) is the most common malignant skin tumor, amongst which the nodular, nodulo ulcerative and superficial types comprise nearly 80% of all BCCs. Topical Imiquimod, an immune response modifier has been found to be effective in superficial and nodular types of BCC with histological clearance rates of up to 100%. We report our experience of treatment a large pigmented BCC on the face with topical Imiquimod 5% cream.     

Imiquimod 5% cream is an acceptable treatment option for external anogenital warts in uncircumcised males

OBJECTIVES: To determine the safety and efficacy of imiquimod (Aldara) 5% cream in the treatment of prepuce-associated warts in uncircumcised males. METHODS: An open-label study in six UK medical centres with 35 uncircumcised males with prepuce-associated warts treated with imiquimod 5% cream three times per week for up to 16 weeks. Other anogenital warts were also treated. RESULTS: Three times weekly application of imiquimod was found to be safe, with erythema as the most commonly reported local skin reaction. Forty per cent of patients had complete clearance of anogenital warts within 16 weeks. CONCLUSIONS: Imiquimod cream at a dosing regimen of three times per week, is effective and has an acceptable safety profile in the treatment of prepuce associated warts and other external anogenital warts in uncircumcised males.     

5％咪喹莫特乳膏治疗尖锐湿疣Meta分析

目的以循证医学的方法对5％咪喹莫特乳膏治疗尖锐湿疣的疗效与安全性进行系统评价。方法检索PubMed、Ovid、Web of Seience、UMI、Elsevier以及Cochrane图书馆、中文科技期刊数据库（CNKI）、中国生物医学文献数据库（CBMDisc），纳入比较5％咪喹莫特乳膏与安慰剂或氟尿嘧啶乳膏的随机对照试验，南两名评价者独立提取资料并进行方法学质量评估。试验数据的统计分析采用Cochrane协作网提供的RevMan4．2培软件进行。结果最终纳入8个临床随机对照试验，对5％咪喹莫特乳膏治疗尖锐湿疣进行了Meta分析，与安慰剂组相比，差异具有统计学意义；与氟尿嘧啶乳膏组相比．疗效差异无统计学意义，没有报道与5％咪喹莫特乳膏临床应用相关的严重系统性不良反应。结论现有临床证据表明，5％咪喹莫特乳膏治疗尖锐湿疣有确切的疗效与较好的安全性。     

A randomized,double-blind,vehicle-controlled study to assess 5% imiquimod cream for the treatment of multiple actinic keratoses

BACKGROUND: Actinic keratoses (AKs) are precancerous epidermal lesions found most frequently on areas of the skin exposed to the sun. Several case studies published recently have indicated that 5% imiquimod cream, currently licensed for the treatment of genital warts, may be an effective treatment for AK. OBJECTIVE: To assess the efficacy and safety of imiquimod for the treatment of AK. DESIGN: Patients in this randomized, double-blind, vehicle-controlled study applied 5% imiquimod cream or vehicle to AK lesions 3 times per week for a maximum of 12 weeks or until lesions had resolved. In the event of an adverse reaction, application of imiquimod was reduced to 1 or 2 times per week. Rest periods were also allowed if necessary. SETTING: A specialized outpatient dermatology clinic within a state-funded hospital in Germany. PATIENTS: The study population was aged 45 to 85 years. Of 52 patients screened, 36 men and women with AK confirmed by histological diagnosis were enrolled. Patients were excluded from the study if they did not have a histological diagnosis for AK, if they were older than 85 years, or if they did not comply with the protocol. All patients had responded to a notice asking for volunteers. MAIN OUTCOME MEASURES: The number and appearance of lesions were evaluated before, during, and after treatment. All adverse effects were recorded. RESULTS: Lesions treated with 5% imiquimod cream were clinically cleared in 21 (84%) of 25 patients and partially cleared in 2 (8%). Clearance was histologically confirmed 2 weeks after the last application of imiquimod in all patients clinically diagnosed as lesion free. Only 10% of patients treated with imiquimod were clinically diagnosed with recurrence 1 year after treatment. No reduction in the size or number of AK lesions was observed in vehicle-treated patients. Adverse effects reported by patients treated with imiquimod included erythema, edema, induration, vesicles, erosion, ulceration, excoriation, and scabbing. However, imiquimod was well tolerated since all patients completed the 12-week treatment. Only a few, mild adverse reactions to the vehicle cream were reported. CONCLUSION: Application of 5% imiquimod cream for 12 weeks is an effective and well-tolerated treatment for AK.     

Topical combination therapy for cutaneous squamous cell carcinoma in situ with 5-fluorouracil cream and imiquimod cream in patients who have failed topical monotherapy

Topical therapeutic options for cutaneous squamous cell carcinoma in situ include 5-fluorouracil cream and imiquimod cream. Such treatment may be preferable to surgical or destructive modalities in certain anatomic locations and in instances where patients are unwilling or poor surgical candidates. We present 4 such patients with cutaneous squamous cell carcinoma in situ involving a digit. Each patient failed treatment with imiquimod cream as monotherapy. In addition, two patients failed treatment with 5-fluorouracil cream as monotherapy. All 4 responded completely to 5-fluorouracil and imiquimod cream as combination therapy. In patients who have failed monotherapy with a topical agent for cutaneous squamous cell carcinoma in situ, combination treatment using both topical 5-fluorouracil cream and imiquimod cream may be considered as an alternative therapeutic strategy.     

Treatment of non-genital warts with topical imiquimod 5% cream

Common warts (verrucae vulgaris) are associated with human papillomavirus infection and are routinely treated by ablative procedures such as cryotherapy, electrodessiccation and salicylic acid. We report 10 cases of recurrent warts treated with a potential new topical therapy, imiquimod 5% cream. Nine of the 10 patients were successfully treated with imiquimod 5% cream applied, under occlusion, once daily for 4 weeks. No recurrences were reported during 3 months of follow up.     

香菇菌多糖联合5%咪喹莫特乳膏预防尖锐湿疣CO_2激光术后复发的疗效观察

目的观察CO2激光去除疣体后,联合应用全身及局部免疫调节剂香菇菌多糖和5%咪喹莫特乳膏预防尖锐湿疣复发的疗效。方法将患者按就诊先后随机分为三组,先用CO2激光去除疣体后:A组给予口服香菇菌多糖片10mg,3次/d;待创面愈合后,同时给予5%咪喹莫特乳膏外用,每周二、四、六晚涂药3次。B组单纯给予5%咪喹莫特乳膏外用。C组单纯给予口服香菇菌多糖片。用法及用量同A组。3组疗程均为8周。观察复发情况及不良反应,12周后进行复发率比较。结果 2周后A,B,C3组的复发率分别为10.42%,30.00%,33.33%。A组复发率明显低于B,C组,差异有统计学意义(P均<0.05)。结论联合应用免疫调节剂香菇菌多糖和5%咪喹莫特乳膏预防尖锐湿疣复发疗效好,复发率低。     

5%咪喹莫特乳膏外用预防尖锐湿疣复发的疗效观察

目的观察5%咪喹莫特乳膏外用预防尖锐湿疣(CA)复发的疗效。方法治疗组43例CA患者予二氧化碳激光祛除疣体后1周于原皮疹部位及其周围0.5cm范围外用5%咪喹莫特乳膏,隔日1次,疗程1月,对照组38例CA患者单用二氧化碳激光治疗,治疗后两组均随访3个月。结果治疗组复发率(6.97%,3/43)明显低于对照组(42.10%,16/38)(P<0.01)。结论 5%咪喹莫特乳膏外用可以明显降低CA的复发率。     

Imiquimod 5% cream as a therapeutic option for extramammary Paget's disease

A wide local excision is the standard treatment for extramammary Paget's disease (EMPD), though this treatment often leads to permanent anogenital mutilation and functional impairment. The purpose of our study is to evaluate the efficacy and safety of the topical application of imiquimod 5% cream for non‐invasive EMPD. We examined nine patients with EMPD. Eight of the nine patients were treated with imiquimod 5% cream three times per week for 16 weeks; one case was treated for 6 weeks. The response rate was 100% including five complete remissions. Local irritation was observed in three patients, which was controlled by a provisional withdrawal of the treatment. These results suggest that imiquimod 5% cream may be considered an alternative therapeutic option for the treatment of non‐invasive EMPD.