Aldara Cream Research Articles

Optimization of cell-wall skeleton derived from Mycobacterium bovis BCG Tokyo 172 (SMP-105) emulsion in delayed-type hypersensitivity and antitumor models

Cell-wall skeleton prepared from Mycobacterium bovis BCG (BCG-CWS) is known as a potent adjuvant and has been shown to possess antitumor activity in many non-clinical and clinical studies. As there are no approved BCG-CWS formulations for cancer therapy, we investigated the potential for cancer immunotherapy of SMP-105, our originally produced BCG-CWS. For optimizing SMP-105 emulsion, we compared the effects of drakeoland squalane-based SMP-105 emulsions on IFN-γ production in rats and evaluated their ability to induce skin reaction in guinea pigs. Both emulsions had the same activity in both experiments. We selected squalane as base material and produced two types of squalane-based formulations (vialed emulsion and pumped emulsion) that can easily be prepared as oil-in-water emulsions. Although the vialed emulsion showed the same pattern of distribution as a usual homogenized emulsion, the pumped emulsion showed more uniform distribution than the other two emulsions. Whereas both emulsions enhanced strong delayed type hypersensitivity (DTH) reaction in a mouse model, the pumped emulsion induced slightly smaller edema. Data on oil droplet size distribution suggest that few micrometer oil droplet size might be appropriate for oil-in-water microemulsion of SMP-105. The antitumor potency of SMP-105 emulsion was stronger than that of some of the launched toll-like receptor (TLR) agonists (Aldara cream, Picibanil, and Immunobladder). Aldara and Picibanil showed limited antitumor effectiveness, while Immunobladder had almost the same effect as SMP-105 at the highest dose, but needed about 10 times the amount of SMP-105. These findings first indicate that SMP-105 has great potential in cancer immunotherapy.

Efficacy of an Immune Modulator in ExperimentalChlamydia trachomatisInfection of the Female Genital Tract

Objective. The aim of this study was to determine if vaginal application of the immune response modifier imiquimod (Aldara cream, 3M Pharmaceuticals, St Paul, Minn) would alter the course and/or outcome of female genital tract infection with a human isolate of Chlamydia trachomatis in a murine model. Methods. Groups of CF-1 mice were treated with Aldara on three different schedules: (1) ongoing beginning 5 days prior to and continuing through day 5 of infection; (2) a single prophylactic dose 2 hours prior to infection; and (3) therapeutic from day 4 to day 14 of infection. Mice were infected vaginally with a serovar D strain of C trachomatis, and monitored by culture to determine the level of shedding and duration of infection. Results. We observed a significant reduction in both duration of infection and the level of shedding during the acute phase in mice treated on an ongoing basis commencing 5 days prior to infection. There was no effect with respect to the other regimens. Conclusion. These results demonstrate that ongoing Aldara treatment has efficacy and may enhance local innate immunity which reduces the duration of subsequent infection with human isolates of C trachomatis in a murine model of female genital tract infection.

A case of Bowenoid papulosis of the penis successfully treated with topical imiquimod cream 5%

Bowenoid papulosis is a pre-malignant condition affecting the ano-genital area. Pathogenesis may be associated with high-risk human papillomavirus genotypes, and sexual transmission is the most likely mode of acquisition. Risk of progression to invasive disease is low. Treatment usually involves locally destructive or ablative therapies. We report well-tolerated, successful clearance of bowenoid papulosis of the penis in a 25-year-old male, using topical Aldara (imiquimod) cream 5%, once every other day for two months.

FDA Approval for Aldara Cream for Superficial Basal Cell Carcinoma

FDA Approval for Aldara Cream for Superficial Basal Cell Carcinoma

Percutaneous penetration of Aldara™ cream, 5% during the topical treatment of genital and perianal warts

Objective: The objective of this single-center, open-label trial was to evaluate the percutaneous penetration of Aldara™ (imiquimod) cream, 5% when applied topically to patients with anogenital warts using a more frequent/aggressive dosing regimen. Methods: Ten otherwise healthy males and six otherwise healthy, nonpregnant, nonlactating females with histology results suggestive of, or diagnostic of, human papilloma virus/condyloma acuminata were enrolled. Females were required to be practicing an acceptable form of contraception control. Patients applied cream daily (8 ± 2 hours) until complete wart clearance, or for a maximum of 16 weeks. Following the initial dose, at approximately week 4, and at the end-of-treatment, patients were confined for 42 hours in order to obtain a series of blood and urine samples. These samples were analyzed for levels of imiquimod and two metabolites, S-26704 and S-27700. Biological marker levels were not included as a part of this trial. Results: No quantifiable (≥5 ng/mL) levels of imiquimod or the two metabolites were observed in any of the serum samples collected. Five patients had quantifiable (≥10 ng/mL) imiquimod, S-26704, or both in urine. No quantifiable levels of S-27700 were observed. Complete clearance of warts occurred in 40% of male patients and 83% of female patients. Erythema was the most frequently observed local skin reaction and was moderate in intensity, although 6 of 16 patients reported a severe erythema reaction at some point in the study. Application site reactions (itching, burning and pain) were the most frequently reported adverse events. Conclusion: The lack of quantifiable levels of imiquimod or metabolites in serum, together with sporadically occurring quantifiable but low levels in urine, indicate that systemic exposure, after daily application of Aldara cream to genital/perianal skin, may occur but is minimal; however, pharmacological (immune marker) effects were not evaluated because cytokine measurements were not obtained. A future trial assessing cytokine levels after topical Aldara therapy with minimal systemic levels of imiquimod would help assess systemic drug and pharmacological effects and utility of this product in pregnant women.

New treatments for genital warts less than ideal: abstract and commentary.

Objective:To compare the safety and effectiveness of 5% and 1% imiquimod cream with vehicle cream in the treatment of external anogenital warts.Design:Randomized, double-blind, placebo-controlled comparison that evaluated patients for total clearance of their warts. Patients who experienced total clearance were evaluated for recurrence in a 12-week follow-up.Setting:Eleven ambulatory offices, including both private physician offices and referral medical centers.Patients:Three hundred eleven healthy men and women aged 18 years or older with 2 to 50 external anogenital warts were recruited from the practices of investigators, referring physicians, and advertisements. Eighty-two additional patients were screened but did not qualify. Four patients discontinued use of the medication because of adverse effects.Interventions:Five percent imiquimod (Aldara) cream, 1% imiquimod cream, or vehicle cream was applied to all external warts overnight 3 times each week for 16 weeks, or until all treated warts disappeared, whichever occurred first.Main Outcome Measurements:The number of patients experiencing the elimination of all baseline warts and the recurrence rate of these warts. In addition, the reduction in baseline wart area, the duration of therapy required to eliminate warts, and the frequency and severity of adverse reactions were principal measurements.Results:In the intent-to-treat analysis, 54 (50%) of 109 patients who received 5% imiquimod cream, 21 (21%) of 102 of those who received 1% imiquimod cream, and 11 (11%) of 100 patients treated with vehicle cream experienced eradication of all treated baseline warts. The difference between the effectiveness of 5% imiquimod cream and the vehicle cream was statistically significant (P<.001). Of those patients whose warts cleared during therapy, 13% of patients who received 5% imiquimod experienced a recurrence of at least 1 wart. Recurrences occurred in none of the patients who used 1% imiquimod cream and in 10% of patients who used the vehicle cream. Local erythema was the most common adverse reaction, but the majority of patients in each group experienced no or only mild local inflammatory reactions. There were no differences in incidences of flulike symptoms among treatment groups.Conclusions:Five percent imiquimod cream is an effective and safe self-administered therapy for external anogenital warts when applied 3 times a week overnight for up to 16 weeks. The recurrence rate is low.