Efficacy Of Imiquimod Research Articles

The efficacy of imiquimod in the treatment of high-grade vulvar dysplasia: A meta-analysis (2178)

The efficacy of imiquimod in the treatment of high-grade vulvar dysplasia: A meta-analysis (2178)

Efficacy of imiquimod in the management of lentigo maligna.

Lentigo maligna (LM) is a melanocytic proliferation occurring on photo-exposed skin that may progress to LM melanoma. Surgery is recommended as first-line treatment. Excision margins of 5-10 mm remain, without international consensus. Several studies have shown that imiquimod, an immunomodulator, induces LM regression. This study investigated the effect of imiquimod versus placebo in neoadjuvant settings. We performed a prospective, randomized, multicentre, phase III clinical study. Patients were randomly assigned in 1:1 ratio to receive imiquimod or placebo for 4 weeks, followed by LM excision 4 weeks after the last application of imiquimod or placebo. The primary endpoint was extra-lesional excision, with a 5 mm margin from the residual pigmentation after imiquimod or vehicle. Secondary endpoints included the gain on the surface removed between the two groups; number of revision surgeries to obtain extra-lesional excisions; relapse-free time; and number of complete remissions after treatment. A total of 283 patients participated in this study; 247 patients, 121 patients in the placebo group and 126 in the imiquimod group, accounted for the modified ITT population. The first extralesional extirpation was performed in 116 (92%) imiquimod patients and in 102 (84%) placebo patients; the difference was not significant (p = 0.0743). Regarding the surface of LM, imiquimod reduced the LM surface (4.6-3.1 cm2 ) significantly (p < 0.001) more compared to the placebo (3.9-4.1 cm2 ). Imiquimod reduces the lentigo maligna surface after 1 month of treatment, without a higher risk of intralesional excision and with a positive aesthetic outcome.

Reflectance Confocal Microscopy Follow-up of Multifocal Superficial Basal Cell Carcinomas Treated With Imiquimod 5% Cream.

Patients with multifocal superficial basal cell carcinomas (sBCC) require a non-invasive treatment and follow-up with a non-invasive technique. Imiquimod 5% cream is a new non-invasive therapy for BCC. Reflectance confocal microscopy (RCM) is a non-invasive, real-time imaging technique. To evaluate and describe the feasibility and efficacy of imiquimod 5% cream for the treatment of multifocal sBCC using RCM. The efficacy of imiquimod 5% cream for the treatment of multifocal sBCC was evaluated, as well as the potential of RCM for assessing therapeutic effects. We reported four patients with 34 sBCC lesions were treated with imiquimod 5% cream. RCM was performed in the baseline and at 12 weeks, 24 weeks and 52 weeks after starting treatment. Of 34 lesions treated with imiquimod 5%, 32 responded to the treatment and showed complete clinical clearing. Two subclinical BCC lesions were identified by RCM. The complete tumor clearance rate was 88.2%, and the efficiency rate was 97.1%. No lesion recurred at 24-month follow-up. RCM identified previously described confocal features of BCC and was more sensitive than clinical examination. Local skin reactions were relieved after expectant treatment. Imiquimod 5% cream may be useful for the treatment of multifocal sBCC, and its side effects are easy to manage. RCM can be used for non-invasive monitoring of treatment response and improved the tumor clearance rate.

Topical 5% Imiquimod as Monotherapy for Primary Cutaneous and Cutaneous Metastatic Melanoma: Systematic Review of the Literature

Background: Surgery is the gold standard treatment for primary cutaneous melanoma but may not be suitable given some comorbiditiies, lesion size or location, or anticipated functional impairment. Imiquimod (IMQ) is a topical immunotherapy infrequently used for melanoma, often in combination with other treatments. Objective: The present work aims to review the available literature on the safety and efficacy of imiquimod in the treatment of cutaneous primary and metastatic melanoma. Methods: We systematically reviewed the literature on topical imiquimod as monotherapy for melanoma, excluding in situ disease. MEDLINE, EMBASE, and CINAHL searches were conducted using terms related to imiquimod and melanoma, results summarized according to the PRISMA Guidelines and quality of evidence assessed using the GRADE tool. Results: Of 559 citations identified, 14 case reports and series with 38 patients with 95 lesions met inclusion criteria. There was heterogeneity in treatment regimens, including the number of applications and treatment length. Complete clearance was observed in 39% of cases, while the stable or progressive disease was seen in 42% of cases; treatment efficacy was limited in cases with prior metastatic disease. Conclusion: The current literature for the use of imiquimod in cutaneous primary and metastatic melanoma remains scarce, with most evidence derived from case reports and series likely to be influenced by selection bias for positive treatment results. Nevertheless, imiquimod remains a relatively well-tolerated treatment for cutaneous primary and metastatic melanoma that may be used in selected cases.

Efficacy of imiquimod 5% cream as first-line management in cutaneous leishmaniasis caused by Leishmania mexicana

Cutaneous leishmaniasis (CL) involves several differential diagnoses as it lacks a gold standard diagnostic test. Its diagnosis is easier in endemic regions; however, many cases come from travelers to endemic areas. A 22-year-old patient, who had recently visited Oaxaca, Mexico, developed two asymptomatic ulcers weeks later on the left auricle and the nose. Leishmania mexicana was identified using polymerase chain reaction. The patient was treated with imiquimod 5% cream three times/week, providing favorable results after 12 weeks, without relapse 2 months after therapy. To our knowledge, this is the first case of CL due to L. mexicana effectively treated with imiquimod.

Safety and Efficacy of Imiquimod in the Treatment of Infantile Hemangioma; a Systematic Review and Meta-Analysis

Objective: To study the safety and efficacy of imiquimod in the treatment of infantile hemangioma (IH).&#x0D; Method: Systematic search was conducted in nine electronic databases for selecting relevant articles reporting the safety and efficacy of imiquimod as a therapeutic agent for treatment of IH. Meta-analysis was used to pool the results.&#x0D; Results: Of total 180 records screened, we included 9 studies for this systematic review and meta-analysis. About one-fifth of the patients (20.9%) have showed clinical resolution with 95% confidence interval (CI) of 11.8% to 34.1%. Regarding IH type, superficial type showed the highest rates of both clinical resolution and excellent response rates with 31.2% (95% CI= 16.6% to 50.8%) and 26.5% (95% CI= 11.6% to 49.6%), respectively. A relatively high prevalence of any side effects with 63.1% (95% CI= 47.6% to 76.3%) has been reported. The highest reported side effect was crustation (44.1%; 95% CI= 27.8% to 61.8%).&#x0D; Conclusion: Imiquimod is effective in the treatment of superficial IH and it is associated with local side effects.

Treatment of Residual or Recurrent CIN with Topical Imiquimod: a Retrospective Study

Abstract Objective In this retrospective case study, we determine the results, side effects and long-term outcome features of treatment with imiquimod 5% in women with recurrent or residual cervical intraepithelial neoplasia (rrCIN). Methods The study was set in three outpatient clinics of hospitals in the Netherlands. Women diagnosed with rrCIN and treated with imiquimod 5% intravaginally between 2010 and up to and including 2017 were included. Data were extracted from medical records. The main outcome measures were complete regression or partial regression of SIL (squamous intraepithelial lesions) (cytology) or CIN (histology), side effects and long-term outcome in terms of the need for further excisional treatment during the follow-up period. Outcomes were assessed using descriptive statistics. Results The 18 studied women tolerated imiquimod well: all completed the treatment, with a temporary stop or dose reduction in two. The treatment was successful in 11 women overall (61%) of whom 8 women (80%) with high grade CIN (grades II-III). Of these 11 women, 4 women developed a recurrence of which 3 women were treated successfully with imiquimod or a LLETZ procedure. One woman died in the follow up without treatment of the CIN lesion. Of the remaining seven women with unsuccessful treatment, four patients underwent additional therapy. Two women underwent a hysterectomy, one woman underwent multiple procedures and the last woman underwent laser therapy and imiquimod, but died in the follow up. Of the remaining three out of those 7 women with unsuccessful treatment, two women refused further therapy and one woman required no further therapy since she cleared HPV and showed no dysplasia in the follow-up period. Conclusions In studied population, imiquimod treatment was well tolerated and associated with resolution or regression of SIL/CIN in 61% of women. We have started a randomized controlled trial to compare the efficacy of imiquimod with that of LLETZ in recurrent or residual CIN.

EFFICACY OF IMIQUIMOD 5% AND PODOPHYLLIN 25% IN TREATMENT OF GENITAL WARTS: A COMPARATIVE STUDY

Introduction and Purpose: Warts are a viral contagious disease that cause concern and result in cosmetic problems. There are several treatments for warts, but none of them is effective, simple, fast and universally applicable to all patients. Due to the high prevalence of warts especially among young adults, finding a low-cost method to effectively treat them without complications seems necessary. Therefore, the purpose of this research was to compare the efficacy of imiquimod 5% and podophyllin 25% in the treatment of warts. Method: This research is a single-blind clinical trial involving 280 individuals diagnosed with warts who visited women's clinic of Imam Khomeini Hospital of Sari in 2017. The Patients were randomly divided into two groups. One group were treated with imiquimod 5%, and the other group were treated with podophyllin 25% lotion three times a week for 8 consecutive weeks. Assessment of the treatment response and examination of drug complications were made four times a week for 8 weeks. In each session, the condition of patients was compared to that of the previous session in order to examine the response to treatment. Treatment complications were also assessed at the end of the treatment. The data were statistically assessed by SPSS. Findings: The statistical population were women with an average age of 29 ± 7.23 (12-47). Results revealed that there was not a significant relationship between the number of lesions, the size of them, the patients’ age, duration of warts, and their location on the body (p>0.05). Podophyllin lotion also had partial response in 52.5% of patients but complete treatment of warts was observed in 44% of them. In the imiquimod group, the response to the treatment was 52.4% and the partial response was %46.1; the number and size of the warts decreased significantly by the end of the treatment. The results of the treatment response assessment showed no significant differences between the two groups (P=0.559); the side effects (itching, erythema and ulcer) was significant in the patients of the podophyllin group (P<0.05). Conclusion: The results of this study showed that application of the imiquimod gel had fewer complications, and its results was the same as those of podophyllin. Given that the former can be applied by the patients at home, it is given priority over podophyllin.

Imiquimod inhibits growth and induces differentiation of myeloid leukemia cell lines

BackgroundThe antitumoral effects of different Toll-like receptor (TLRs) agonists is mediated by activating immune responses to suppress tumors growth, although TLR ligands may also have a direct effect on tumoral cells. Given that TLR signaling induces hematopoietic cell differentiations this may serve as a novel differentiation therapeutic approach for AML.MethodsWe investigated the effects of agonists for the ten human TLRs on the proliferation, apoptosis, cell cycle and differentiation of ten different types of myeloid leukemia cell lines (HL-60, U-937, KG-1, KG-1a, K-562, Kasumi-1, EOL-1, NB4, MOLM-13 and HEL). Proliferation was measured using the CellTiter 96® Aqueous One Solution Cell Proliferation Assay (Promega). Staining and analysis with a flow cytometer was used to identify cell cycle progression and apoptosis. Differentiation was measured by staining cells with the EuroFlow™ antibody panel for AML and analyzed by flow cytometry. FlowJo software was used to analyze the cytometric data. In all experiments, statistical significance was determined by a two-tailed t test.ResultsThe activation of particular TLRs on some cell lines can induce growth inhibition and Imiquimod (a TLR 7 agonist) was the most effective agonist in all leukemic cell lines examined. Imiquimod was able to induce apoptosis, as well as to induce cell cycle alteration and upregulation of myeloid differentiation markers on some of the cell lines tested.ConclusionsOur results, together with the known efficacy of Imiquimod against many tumor entities, suggest that Imiquimod can be a potential alternative therapy to AML. This drug has a direct cytotoxic effect on leukemic cells, has the potential to induce differentiation, and can also stimulate the activation of cellular immune responses anti-AML.

Association between the clinical and histopathological classifications of actinic keratosis and the efficacy of topical imiquimod treatment

We investigated the association between the clinical and histopathological classifications of actinic keratosis (AK) and the efficacy of topical imiquimod treatment. Forty patients (55 lesions) with AK were treated with topical 5% imiquimod and the efficacy of imiquimod for AK was evaluated based on the clinical/histopathological changes. The complete remission (CR) rates in patients with the different clinical classifications of AK were 85.4% (erythematous type) and 46.2% (hyperkeratotic type). The CR rates in the different histopathological classifications of AK were 80% (hypertrophic type), 81.8% (atrophic type) and 42.9% (bowenoid type). The results revealed that determining the clinical and histopathological type of AK was important for selecting a therapeutic method. The topical imiquimod treatment could be expected to be more effective for AK clinically classified as the erythematous type, or histopathologically classified as the atrophic or hypertrophic type. However, it would be expected to be less effective for the treatment of AK clinically classified as the hyperkeratotic type or histopathologically classified as the bowenoid type. Our observations suggest that we can predict the efficacy of topical imiquimod therapy in AK by determining its clinical and histopathological type.

Twelve-week Treatment of Lentigo Maligna with Imiquimod Results in a High and Sustained Clearance Rate

Topical imiquimod cream is increasingly applied in the treatment of lentigo maligna (LM), in particular for large lesions where surgery may lead to disfiguring scars. Published studies suggest that more frequent and prolonged treatment with topical imiquimod is associated with higher efficacy. In this study we prospectively treated 27 patients suffering from LM on the face with imiquimod 5% cream using an intensive treatment regimen consisting of daily applications for 12 weeks inducing skin inflammation for at least 10 weeks. Twenty-four patients completed the treatment as recommended, 23 were available for follow-up (mean 39 months). Clinical and histo-pathological clearance was observed in 20 patients after a mean of 14 weeks of treatment. Notably, histopathological examination of a skin biopsy showed clearance of the LM in all 24 patients, including those who still showed some hyperpigmentation at 4 weeks off treatment. A clinical recurrence occurred in only 1 of the 23 patients available at follow-up. These findings suggest that the efficacy of imiquimod can be improved by implementing a more intensive treatment regimen. Randomized controlled trials are needed to confirm our results and establish the role of topical imiquimod in the treatment of LM.

Imiquimod in the treatment of cutaneous warts: an evidence-based review.

Cutaneous warts are highly prevalent lesions caused by the infection of keratinocytes by different types of human papillomaviruses. Although cutaneous warts are capable of resolving spontaneously, these infections can persist for long periods of time by evading the host immune system, and, as a result, many patients choose to seek treatment. Imiquimod is an immune response modifier that is approved as a topical cream for the treatment of anogenital warts by the US Food and Drug Administration. However, the efficacy of imiquimod in the treatment of cutaneous warts has not been well established. The purpose of this article is to systematically review the published literature regarding the efficacy of imiquimod in the treatment of cutaneous warts, and to evaluate the quality and outcomes of these studies. A literature search was performed through clinical queries PubMed (National Library of Medicine) database and the Cochrane database. All completed studies written in English and published through May 2014 were considered. Studies evaluating the use of imiquimod for anogenital warts were excluded. There were no other restrictions based on patient age, sex, ethnicity, or skin type. The studies were evaluated and assessed based on study design, patient population, treatment regimen, clinical outcome, and adverse events. A total of 393 records were identified in the initial search; 23 full-text articles were assessed for eligibility and included in the review. Of these studies, six publications reported on immunocompromised individuals only. The highest quality study identified was a grade B, level 3 case-control cohort study in which patients with multiple warts had certain warts treated with imiquimod and others left untreated to serve as a control. The remaining studies identified were level 4 non-controlled case series (grade C) and level 5 case reports (grade D). In immunocompetent patients enrolled in non-controlled studies, the combined rate of patients achieving complete response to therapy was 44%, ranging from 27 to 89%. However, there was variation in the dose frequency and application among these studies. In immunosuppressed patients, two studies and four case reports were identified. Clinical improvement was seen in 33-50% of patients, with no patients experiencing complete clinical clearance. There have been several studies demonstrating the successful use of imiquimod to treat recalcitrant cutaneous warts, either alone or as combination therapy. However, these studies are limited in number, include small populations, and are non-controlled. Further studies are needed to determine the efficacy of imiquimod, dose frequency and application, and optimal combination with other therapeutic measures such as paring, salicylic acid, or other destructive procedures.

An investigator-initiated study to assess the safety and efficacy of imiquimod 3.75% cream when used after cryotherapy in the treatment of hypertrophic actinic keratoses on dorsal hands and forearms

To evaluate the efficacy of combination cryotherapy and imiquimod 3.75% cream versus cryotherapy alone in the treatment of hypertrophic actinic keratosis on the dorsal hand and forearm.Twenty subjects with at least three hypertrophic actinic keratoses on each dorsal hand or forearm underwent cryotherapy treatment to hypertrophic actinic keratoses. Following cryotherapy, subjects were randomized to have either their right or left dorsal hand or forearm treated with imiquimod 3.75% cream to begin on the same day as cryotherapy treatment. Subjects then utilized the two weeks on, two weeks off, two weeks on regimen of imiquimod 3.75% cream application. Local skin reactions were also assessed.For the cryotherapy/imiquimod 3.75% arm, the median total hypertrophic actinic keratosis reduction was -5.12 and for the cryotherapy alone arm, the median total hypertrophic actinic keratosis reduction was -2.24 (P<0.0094).Local skin reactions unbind the investigator.Cryotherapy plus imiquimod 3.75% cream resulted in a statistically significant improvement in the reduction of hypertrophic actinic keratoses than cryotherapy alone at 14 weeks.

New Alternative Combination Therapy for Recalcitrant Common Warts: The Efficacy of Imiquimod 5% Cream and Duct Tape Combination Therapy

New Alternative Combination Therapy for Recalcitrant Common Warts: The Efficacy of Imiquimod 5% Cream and Duct Tape Combination Therapy

Treatment of Cervical Intraepithelial Neoplasia With Topical Imiquimod

Cervical intraepithelial neoplasia (CIN) is a common disease among women of reproductive age. High-grade CIN lesions (CIN 2–3) are precancerous and can progress to cervical cancer. The most important risk factor for the development of CIN and progression to cervical cancer is persistent high-risk human papillomavirus (HPV) infection. The preferred treatment in most countries is surgical excision using conization. There is high need for a medical treatment alternative to surgical therapy for CIN 2–3 largely because of the risk of preterm birth and other long-term sequelae of cervical conization in future pregnancies. No medical therapy has been established in clinical practice for patients with CIN 2–3. In 2008, a study reported on the efficacy of imiquimod, a topical immune response modulator, against HPV-related vulvar intraepithelial neoplasia. Earlier this year, a randomized controlled trial found that combined use of imiquimod and conization did not improve CIN 2–3 recurrence rates compared with use of conization alone. However, the study had a number of design flaws. A major problem was the application of imiquimod only 5 times before surgery, an uncommon and short treatment regimen. The aim of the present randomized, double-blind, placebo-controlled phase 2 trial was to estimate the therapeutic efficacy of vaginal, self-applied imiquimod in women with high-risk HPV-positive CIN 2–3. Study subjects were 59 patients with untreated, histologically proven, high-risk, HPV-positive, and newly diagnosed CIN 2–3. Eligible women were randomized to receive either treatment with self-applied vaginal suppositories containing imiquimod or placebo for 16 weeks. The primary study outcome was efficacy, defined as histologic regression to CIN 1 or less following treatment. Secondary outcomes included complete histologic remission, HPV clearance, and treatment tolerability. A sample size of 24 patients per group was calculated to detect a 35% absolute increase in CIN 2–3 regression (imiquimod vs. placebo), assuming a 2-sided 5% significance level and a power of 80%. All patients tested positive for high-risk HPV at baseline. After 16 weeks of treatment, histologic regression to CIN 1 or less was achieved in 73% in the imiquimod group compared with 39% in the placebo group (P = 0.009). There was a higher complete histologic remission in the imiquimod group (47%) than in the placebo group (14%) (P = 0.008). Human papillomavirus clearance rates after treatment were 60% in the imiquimod group and 14% in the placebo group (P < 0.001). Complete remission rates among patients with HPV-16 infection were 47% in the imiquimod group and 0% in the placebo group (P = 0.003). Three of the 59 patients (5%), all within the placebo group, were found to have microinvasive cervical cancer after treatment. Topical imiquimod had no high-grade adverse effects; treatment was well tolerated. These findings suggest that vaginal imiquimod therapy is an efficacious, feasible, and well-tolerated medical treatment for patients with CIN 2–3.

Efficacy and Safety of Imiquimod Versus Podophyllotoxin in the Treatment of Anogenital Warts

Anogenital warts are a common sexually transmitted disease caused by human papillomaviruses. Despite the fact, that imiquimod and podophyllotoxin represent common topical agents, direct comparative studies lack. This work compares the effectiveness and safety of self-applied imiquimod 5% cream and podophyllotoxin 0.5% solution. Within 2 years, consecutive patients presenting with untreated anogenital warts were included in a randomized, open label trial. The primary endpoint was complete clearance at the end of treatment (4 weeks after the start with podophyllotoxin, 16 weeks after the start of imiquimod therapy). Side effects were evaluated as a secondary endpoint. A total of 45 patients, 7 women and 35 men, of whom 5 were circumcised, concluded the treatment and were eligible for evaluation. The rates of clearance of baseline warts among treatment groups were 72% (95% confidence interval [CI], 52%-86%) in the podophyllotoxin group and 75% (95% CI, 53%-98%) in the imiquimod group. Statistically, clearance rates were identical (P=1). The differences in side effects between treatment groups were statistically not significant (P=0.24). The current study, a direct comparison of both, confirms the previously obtained mathematical data, that imiquimod 5% cream and podophyllotoxin 0.5% solution have an identical beneficial effect on anogenital warts and are associated with identical and acceptable side effects. Both substances constitute effective and safe treatments of untreated anogenital warts in immunocompetent individuals.

Effect of dosing frequency on the safety and efficacy of imiquimod 5% cream for treatment of actinic keratosis on the forearms and hands: a phase II, randomized placebo-controlled trial

Effect of dosing frequency on the safety and efficacy of imiquimod 5% cream for treatment of actinic keratosis on the forearms and hands: a phase II, randomized placebo-controlled trial

Imiquimod 5% Cream: A Review of Its Safety and Efficacy in the Management of Superficial Basal Cell Carcinoma

Imiquimod 5% cream (Aldara) was approved by the Food and Drug Administration for the treatment of non-facial superficial basal cell carcinomas (sBCC) in 2004 and has become one of the most commonly used topical treatments for this variant of basal cell carcinoma. Application of the cream once a day, 5 days per week for 6 weeks has demonstrated a clinical and histological cure rate approximating 80% for non-facial sBCCs. Erythema, erosions, and crusting are common local adverse events; but systemic side effects are much less common. The clinical use of imiqimod for nodular or facial basal cell carcinomas, particularly on the nose, has not been as successful. Cure rates range from 42%–76%, depending on the frequency and duration of use. Several reports have described the usefulness of imiquimod cream as an adjunctive therapy of basal cell carcinomas when combined with a surgical modality. However, most of these “adjunctive” studies were neither blinded nor controlled. We review the safety and efficacy of imiquimod 5% cream in the treatment of sBCC, report on its effectiveness in the treatment of nodular and facial basal cell carcinomas, and comment on its role as an adjunctive therapy.

Effect of dosing frequency on the safety and efficacy of imiquimod 5% cream for treatment of actinic keratosis on the forearms and hands: a phase II, randomized placebo-controlled trial

Clinical studies in cutaneous conditions other than actinic keratosis (AK) have revealed that the safety and efficacy profile of imiquimod is influenced by dosing frequency. To evaluate dosing frequency response of imiquimod 5% for treatment of AK. This was a phase II, multicentre, randomized, double-blind, placebo-controlled study. Adults with > or = 10 but < or = 50 clinical AKs, one of which was histologically confirmed, were randomized (4:1) to 2-6 packets of imiquimod or placebo cream applied to the dorsum of the forearms and hands once daily 2, 3, 5 or 7 times per week for 8 weeks. The primary endpoint was complete clearance of AKs in the treatment area at 8 weeks post-treatment. One hundred and forty-nine (94 men and 54 women) white subjects, with a mean +/- SD age of 71 +/- 10.2 years, were enrolled. Twenty-eight subjects (18.8%) discontinued from study: 0%, 3.1%, 6.9%, 30.0% and 33.3% withdrew for local skin reactions or adverse events in the combined placebo, and in the imiquimod 2, 3, 5 or 7 times per week groups, respectively. Seven serious adverse events occurred; none was related to the study drug. Median baseline lesions ranged from 38 to 40 for the treatment groups. Complete clearance was achieved in 0%, 3.2%, 6.9%, 3.3% and 6.7% of subjects, and partial clearance (> or = 75% lesion reduction) in 0%, 22.6%, 24.1%, 20.0% and 36.7% of subjects for the placebo and imiquimod 2, 3, 5 or 7 times per week regimens, respectively. Imiquimod 5% applied more frequently than 3 times per week to AKs was not well tolerated. Complete clearance rates were low; however, partial clearance rates increased with increased dosing frequency (P = 0.002).

Treatment of multiple, multiform actinic keratoses on the head with imiquimod 5% cream

The objective of this non-controlled interventional clinical study was to evaluate the efficacy of imiquimod in the treatment of fields with multiple, multiform AK. 180 office-based dermatological practices in Germany participated. Patients with clinically typical, visible AK lesions on the head were treated with 5% imiquimod cream 3 times per week for 4 weeks followed by a 4 week treatment pause. If lesions were still present, a second treatment course of treatment (COT) was given. Complete clearance rate, i.e. no clinically visible AK lesions in the treatment area, was the main outcome measure. 829 patients were enrolled. The complete clearance rate was 40.5% after the first COT and 68.9% overall. Altogether, 85.4% of the 7,427 baseline lesions were cleared. Patients with hyperkeratotic/hypertrophic lesions showed comparable responses. Local skin reactions were the most commonly reported adverse effects, causing discontinuation in only 4 patients. Severity of the local skin reactions was a strong predictor of the outcome. Patients with multiple multiform AK on the head can be successfully and safely treated with topical imiquimod in daily practice. Assurance of patient understanding that treatment success is closely correlated to proper drug administration is important.