Treatment of Zoon's balanitis with imiquimod 5% cream

We report a case of a 43-year-old uncircumcised Caucasian, diabetic man with a 4-year history of Zoon's balanitis unresponsive to topical steroids, in whom control of the disease was achieved with topical imiquimod. A histopathological examination of a biopsy specimen was performed before and after treatment with imiquimod 5% cream applied 3 times a week. A moderate to marked increased local skin reaction occurred several times throughout the treatment period, necessitating multiple rest periods of several days' duration. Clinical but not histological resolution was obtained after 4 months of treatment, with no relapses at an 18-month follow-up. This positive treatment outcome indicates that imiquimod may have a role in the management of Zoon's balanitis. However, the dose and duration of therapy required to achieve complete clinical response still needs to be established. Also, the question of whether normalization of histology can be achieved with topical imiquimod has yet to be answered.     

Treatment of dysplastic nevi with 5% imiquimod cream, a pilot study

OBJECTIVE: To assess the clinical and histologic effects of topical imiquimod therapy on dysplastic nevi, and to determine the feasibility of using in vivo confocal microscopy (CSLM) to non-invasively monitor histological response of dysplastic nevi to imiquimod therapy. DESIGN: Single-blinded pilot study with patients not blinded as to treatment status. SETTING: Dermatology Outpatient Clinic, Memorial Sloan-Kettering Cancer Center, New York, NY. PATIENTS: The study population comprised of 10 patients with clinically dysplastic (atypical) nevi and at least 8 large nevi, (> or =5 mm) on their trunk. INTERVENTION: Sixteen weeks of imiquimod 5% cream applied to treatment lesions 3 times per week. MAIN OUTCOME MEASURE: Clinical response as gauged by comparison of baseline and week 20 1:1 standardized photographs for all study nevi and histological assessment of each patient's 4 largest study nevi at completion of therapy. RESULTS: There were no obvious clinical changes in the size and morphology of the study nevi. Subtle changes in nevus color could not be assessed due to imperfect spectral registration of images over the course of the study. Histologically, 4 of 14 treated nevi and 0 of 14 untreated nevi p=0.03 showed a significant relative reduction of junctional and intraepidermal nevocytes accompanied by papillary dermal fibroses and variable inflammation suggestive of partial regression. Non-invasive CSLM imaging of study nevi demonstrated previously reported in vivo features of dysplastic nevi. but the imaging equipment and protocol utilized proved inconsistent across lesions and time. CONCLUSIONS: The histological changes seen in a subset of treated nevi suggest a possible role for the use of topical immune response modifiers for the treatment of dysplastic nevi with the intent of melanoma chemoprevention. The dose regimen of topical imiquimod utilized in this study failed to induce sufficient clinical or histological responses to warrant further study. Targeting of dysplastic nevi and intermediate endpoints for melanoma chemoprevention with more intense and/or prolonged treatment regimens with imiquimod or the use of other immune response modifiers seems promising. Technical improvements are required for the use of non-invasive CSLM imaging in lieu of invasive histology for the study of topical nevus therapies.     

Bowen's disease of the penis treated with topical imiquimod 5% cream

Bowen's disease of the penis is relatively uncommon, but the prevalence has increased in recent years. Risk factors for penile squamous cell cancer include smoking, infection with human papilloma virus (HPV), immunosuppression, and a history of conditions such as balanitis, phimosis, and lichen sclerosis et atrophicus. Bowen's disease of the penis is often managed by local excision of the lesion. Less invasive methods are now employed more frequently and include laser ablation, electrodessication and curettage, cryosurgery, application of5-fluorouracil, and topical imiquimod 5% cream. This case report describes the successful treatment of Bowen's disease of the penis with topical imiquimod 5% cream in a 42-year-old African American male with human immunodeficiency virus (HIV) disease.     

Nonsyndromic multiple basal cell carcinomas successfully treated with imiquimod 5% cream

This report describes the case of a 60-year-old man with nonsyndromic multiple basal cell carcinomas that responded to imiquimod 5% cream. The patient had no additional anomalies suggesting any syndromes associated with multiple basal cell carcinomas. By applying the agent 5 times a week for 20 weeks, we obtained good clinical results, and we confirmed the improvement with histopathologic examination. We suggest that patients with multiple basal cell carcinomas should be interviewed about and tested for the associated syndromes, and topical imiquimod should be kept in mind as an alternative therapy choice in these patients.     

Severe reaction to 5% imiquimod cream with excellent clinical and cosmetic outcomes

Imiquimod, an immune response modifier approved for the treatment of external genital warts, actinic keratoses, and superficial basal cell carcinoma, can induce a severe local inflammatory response. This phenomenon can accompany inappropriately overzealous, as well as entirely conventional, drug utilization. Despite strikingly brisk reactions, the 9 patients reported herein ultimately experienced excellent cosmetic and clinical outcomes. We report this series to alert clinicians of the good prognosis for a satisfactory outcome even when faced with extreme imiquimod cream-induced inflammation.     

Comparison of 5% 5-fluorouracil cream and 5% imiquimod cream in the management of actinic keratoses on the face and scalp

It is timely to compare the efficacy and tolerability of 2 actinic keratosis (AK) therapies--5% 5-fluorouracil (5-FU) cream and imiquimod cream. Thirty-six patients with 4 or more AKs were randomly assigned to receive 5% 5-FU cream twice daily for 2 to 4 weeks or 5% imiquimod cream twice weekly for 16 weeks. Five percent 5-FU was more effective than imiquimod in exposing what were presumed to be subclinical AKs, reducing the final AK count (total AK count declined during the 24-week study by 94% vs. 66%, P < .05), achieving complete clearance (incidence of 84% vs. 24% by week 24, P < .01), and achieving clearance rapidly. Tolerability was similar except for erythema, which was initially significantly higher with 5-FU than imiquimod but resolved rapidly and was significantly lower than imiquimod by week 16. Five percent 5-FU remains the gold standard field therapy for AKs.     

艾拉光动力联合咪喹莫特乳膏治疗扁平疣的疗效

目的 观察艾拉光动力联合5%咪喹莫特乳膏治疗扁平疣的临床疗效。 方法 选取2010年5月至2014年10月收治的81例扁平疣患者,随机分为观察组41例与对照组40例。对照组患者仅给予5-氨基酮戊酸光动力疗法,而观察组患者在光动力治疗基础上再于患处涂抹5%咪喹莫特乳膏8周。治疗结束后连续3个月观察两组患者的临床疗效与复发情况并比较分析。 结果 观察组患者的总有效率为100.00%,高于对照组的92.50%,两组差异无统计学意义(P >0.05);②观察组患者复发率为5.26%,而对照组患者复发率为28.57%,两组比较差异有统计学意义(P <0.05)。结论 艾拉光动力联合5%咪喹莫特乳膏治疗扁平疣可以有效提高临床疗效,降低复发率。     

5%咪喹莫特乳膏每日1次治疗尖锐湿疣68例

目的观察5%咪喹莫特乳膏每日一次治疗尖锐湿疣的疗效。方法尖锐湿疣患者98例,分为2组。试验组68例,每日患处直接外用足量5%咪喹莫特乳膏一次,共4 wk。对照组30例,隔日患处直接外用足量5%咪喹莫特乳膏一次,共8 wk。观察治疗前后疣体发生的部位、数目、形状、大小及用药后局部刺激和全身不良反应。结果试验组退出1例,治疗4 wk后有效率为69%(46/67),对照组治疗8 wk后有效率为73%(22/30),2组疗效无显著差异(P>0.05)。试验组疣体消退时间为(12.5±6.5)d,对照组为(40.5±12.2)d,试验组短于对照组,差异有显著意义(P<0.05)。试验组不良反应发生率为50%,对照组为40%,无显著差异(P>0.05)。结论 5%咪喹莫特乳膏每日一次治疗尖锐湿疣疗效与隔日一次相当,可缩短疗程。     

5％咪喹莫特乳膏治疗浅表型婴儿血管瘤的临床疗效研究

目的：5％咪喹莫特乳膏（明欣利迪,四川明欣药业提供,批号：10091）作为一种新的免疫调节剂在国内已开始用于多种疾病的治疗,本研究旨在观察咪喹莫特治疗浅表型婴儿血管瘤的疗效。方法：60例浅表型婴幼儿血管瘤,平均年龄在17周,每周三次外用5％咪喹莫特乳膏,至一岁时,观察用药前后对比疗效和不良反应发生情况。治疗的消退程度以百分数计算,并比较IH各临床表型间有效率的统计学差异,用爿。检验。结果：60浅表型婴儿血管瘤（IH）的有效率为75％,使用前后疗效有统计学差异。不良反应主要为轻微皮肤红斑。结论：外用5％咪喹莫特乳膏对浅表型婴儿血管瘤有明显的疗效且使用安全,不良反应轻微。     

Safety studies of topical imiquimod 5% cream on normal skin exposed to ultraviolet radiation

BACKGROUND: Imiquimod 5% topical cream is an immune response modifier that induces interferon alpha and interleukin-12, and exhibits antiviral and tumor-inhibiting properties. It is currently available for treatment of genital and perianal warts. Three randomized, open-label or assessor-blinded, placebo-controlled studies were carried out to assess its safety on normal white skin exposed to ultraviolet radiation (UVR). METHODS: Healthy white volunteer adult subjects between the ages of 18 and 60 years with skin types I, II or III (Fitzpatrick Scale, US Federal Register 43:38260, 1978) were invited to participate. Imiquimod 5% cream (each dose approximately 0.1-0.2 ml) was compared with placebo cream. Two preliminary studies assessed the potential photosensitizing properties of the drug, and the third study added measurement of sunburn cell counts (SBC) and deoxyribonucleic acid (DNA) pyrimidine dimer (PD) formation. The three studies were: a 6-week standard photocontact allergenicity bioassay; a 4-day standard phototoxicity bioassay; and a 4-week photodamage study using biopsy sample analyses to determine SBC or PD frequency. RESULTS: Imiquimod had no detectable potential for inducing either photocontact allergy (n=115) or phototoxicity (n=20). The final study further assessing photodamage potential of imiquimod included 44 subjects. There were no significant differences between imiquimod vs. the control (no drug+UVB) for SBC counts (mean 0.88 vs. 0.93), or PD frequency (mean 60.86 vs. 70.03). CONCLUSIONS: Results from the two preliminary safety studies suggest that imiquimod 5% cream does not possess a detectable photosensitizing potential in humans. Furthermore, topical imiquimod did not enhance UVR-induced damage to epidermal cells or DNA.     

Treatment of genital herpes in males with imiquimod 1% cream: a randomised, double-blind, placebo-controlled study

OBJECTIVE: The aim of this randomised, double-blind, placebo-controlled study was to examine the clinical significance, efficacy and tolerability of imiquimod 1% cream to manage patients exposed to first episodes of genital herpes. PATIENTS: Male patients (n = 60), ranging in age between 18 and 50 years (mean 25.7 years), presenting for <6 days (mean 4.4 days) with culture-confirmed diagnosis of genital herpes, and bearing a total of 696 lesions (mean 11.6 lesions/ patient), entered the study and were randomised to receive a precoded 40g tube and instructions on how to apply the trial medication to their lesions twice for 5 consecutive days per week. RESULTS: A marked clinical benefit from self-application of imiquimod 1% cream was demonstrated, resulting in both significantly shorter mean duration of healing than with the placebo (5.2 vs 14 days; p < 0.001) and more healed patients [23 of 30 (76.7%) vs 2 of 30 (6.7%); p < 0.0001]. Of the 60 patients, 54 (90%) reported no drug-related adverse effects. Two patients in the imiquimod group reported non-objective mild burning sensation and four experienced a transitory increase in their body temperature (>38 degrees C) accompanied by mild headache and malaise; however, such indications were not severe enough to cause discontinuation of the treatment, and resolved within 24 hours. Treatment was well tolerated by all the patients, with no dropouts. Among 25 healed patients, four had a relapse after 9 months. CONCLUSION: Although the analogue of imiquimod 1% cream demonstrated mild to moderate subjective adverse effects, it was significantly more effective than placebo in treating patients with a first episode of genital herpes. Further clinical studies appear warranted.     

Pilot study using topical imiquimod 5% cream in the treatment of nodular basal cell carcinoma after initial treatment with curettage

BACKGROUND: Nodular basal cell carcinoma (nBCC) is the most common cutaneous malignancy and studies assessing the use of topical imiquimod 5% cream as a monotherapy in the treatment of nBCC have resulted in less than optimal clearance rates. OBJECTIVE: This pilot study was designed to evaluate the efficacy of imiquimod 5% cream on nodular basal cell carcinoma lesions after initial treatment with curettage. METHODS: After obtaining informed consent, 17 nBCCs on 15 patients were included in this institutional review board-approved, open-label study with initial treatment using curettage without electrodesiccation followed by once-daily application of imiquimod 5% cream 5 times per week for 6 weeks. The area was excised and examined histologically 6 weeks after cessation of imiquimod cream. RESULTS: All 17 lesions (100%) showed no histologic evidence of residual tumor on the post-treatment excision. Local site reactions necessitating a rest period from medication application were experienced by most patients (67%), but the majority of patients stated that they would choose this treatment modality over excision if they developed a subsequent tumor. CONCLUSION: Imiquimod 5% cream appears to be an effective treatment method for nodular basal cell carcinoma if combined with curettage prior to application.     

Pharmacokinetics of daily self-application of imiquimod 3.75% cream in adult patients with external anogenital warts

Imiquimod 3.75% cream is a new formulation intended for daily self-application. The objective of this study was to characterize serum imiquimod pharmacokinetics under maximal use conditions. Adults with ≥8 warts or total wart area ≥100 mm2 applied up to 1 packet of imiquimod 3.75% cream (250 mg cream, 9.375 mg imiquimod) once daily for 3 weeks. Blood was obtained prior to doses 1, 7, 14, and 21 and at selected time points after doses 1 and 21. Eighteen patients (13 men and 5 women) with a median wart count of 16 and total wart area of 60 mm2 were enrolled. Day 21 mean (SD) serum C(max) was 0.49 (0.37) ng/mL, AUC???? 6.80 (3.59) ng·h/mL, and t(1/2) 24.1 (12.4) hours. Steady state was achieved by day 7 with ~2-fold increase in C(max) and AUC after multiple dosing. Overall, C(max) was higher and t(max) shorter in women, with comparable AUC????. Imiquimod metabolites were sporadically quantifiable. No patients discontinued for adverse events; 1 interrupted dosing for an application site ulcer. Treatment-related adverse events occurred in 16.7% of the patients. In conclusion, serum imiquimod concentrations were low after daily self-application to external anogenital warts of up to 1 packet of imiquimod 3.75% cream for 21 days.     

Treatment of all basal cell carcinoma variants including large and high-risk lesions with 5% imiquimod cream: histological and clinical changes, outcome, and follow-up

Forty-one patients with 47 basal cell carcinomas (BCCs; 15 superficial, 26 nodular, and 6 sclerodermiform) were treated with 5% imiquimod cream once daily 5 times a week for 6 weeks in an open-label clinical trial. The overall response rate was 95.7%. Local side effects occurred in 68% of the patients as mild to moderate reactions with a clear association to the histological BCC subtype. Follow-up examinations for up to 17 months (median 10 months) showed scars in 14.9% of the patients and a recurrence rate of 6.6%. Overall, imiquimod represents a safe and effective treatment option for a selected cohort of BCC patients. Notably, by the second week of treatment 72.7% of BCC biopsies were histologically tumor-free, which correlated with a substantial decrease of the inflammatory infiltrate by up to 58% between weeks 3 to 6. This early imiquimod response might have important implications for the final definition of potentially shorter imiquimod treatment periods.     

5%咪喹莫特乳膏外用联合CO2激光治疗尖锐湿疣的疗效观察

目的探讨分析5%咪喹莫特乳膏外用联合CO2激光治疗尖锐湿疣（CA）的临床疗效。方法将160例患者按就诊先后顺序分为4组（每组各40例）,治疗1组采用5%咪喹莫特乳膏外用联合CO2激光治疗,治疗2组单独外用5%咪喹莫特乳膏治疗,对照1组单独使用CO2激光加赋形剂外用治疗,对照2组单独外搽0.5%竹叶草毒素加赋形剂外用治疗。结果治疗1组、治疗2组痊愈率为82.5%和72.5%,明显优于对照1组、对照2组的47.5%和50.0%（P〈0.05）;治疗1组和治疗2组的复发率分别为17.5%和27.5%,明显低于对照1组和对照2组的52.5%和50.0%（P〈0.05）;治疗1组和治疗2组的不良反应发生率分别为25.0%和20.0%,明显高于对照1组和对照2组（P〈0.05）。结论应用5%咪喹莫特乳膏外用联合CO2激光治疗CA疗效显著,能够快速将疣体清除,有效降低疾病的复发率和提高临床痊愈率,值得临床推广。     

Treatment of pityriasis rubra pilaris with pimecrolimus cream 1%

Pityriasis rubra pillaris is an uncommon idiopathic dermatosis considered both a keratinization and an inflammatory disorder. Treatment is largely based on the information presented in case reports. We report the case of a young man with pityriasis rubra pillaris limited to the scalp and face, which cleared completely after application of pimecrolimus 1% cream for 2 weeks.     

Imiquimod 5% cream (Aldara)

Imiquimod is a novel synthetic molecule with potent immune-modifying activities. Formulated in a 5% vanishing cream as Aldara, this self-applied therapy has shown good efficacy and safety in the treatment of external genital and perianal warts caused by human papillomavirus (HPV) infection (Condyloma acuminata). The molecule does not demonstrate direct antiviral activity, but through induction of cytokines results in immune-based resolution of wart tissue and reduction of viral burden. Phase III trials of imiquimod have demonstrated that patients who experience complete clearance of either new or recalcitrant warts tend to remain clear, possibly related to Th1 immune recognition and memory. Self-application, good tolerability and a unique mechanism of action combine to make imiquimod a reasonable first-line therapy for genital warts. The effects of imiquimod on immune function suggest several potential uses. Preclinical studies of infection with herpes simplex virus (HSV), cutaneous leishmaniasis, Rift Valley Fever virus and vesiculostomatitis virus have shown reduced viral persistence, reduced recurrence (HSV) and diminished pathology (Leishmania donovani). In a murine tumour model using the FCB bladder cancer cell line, imiquimod behaves as a potent adjuvant leading to immune-based tumour cell eradication and immunity against subsequent FCB cell challenge. The ability of imiquimod to induce significant production of interferon alpha (IFN-alpha) by monocytes/macrophages suggests that diseases responsive to recombinant interferon therapy, such as basal cell carcinoma, may be reasonable clinical targets. The induction of tumour necrosis factor alpha (TNF-alpha), interferon gamma (IFN-gamma) and interleukin-12 (IL-12) leads to inhibition of IL-5, with animal models demonstrating immune deviation away from Th2 immune responses. The observation that several patients with hepatitis C infection and eosinophilia showed normalisation of elevated eosinophil counts in association with oral imiquimod therapy encourages further exploration of the immune modifying properties of this novel molecule. This review is focused on the use of imiquimod for the treatment of external genital and perianal warts.