ZYCLARA (imiquimod) Cream, 2.5% or 3.75% is intended for topical administration. Each gram contains 25 mg or 37.5 mg of imiquimod, respectively, in a white to faintly yellow oil-in-water cream base consisting of isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben.
ZYCLARA Cream, 2.5% and 3.75% are indicated for the topical treatment of clinically typical visible or palpable, actinic keratoses (AK), of the full face or balding scalp in immunocompetent adults.
External Genital Warts
ZYCLARA Cream, 3.75% is indicated for the treatment of external genital and perianal warts (EGW)/condyloma acuminata in patients 12 years or older.
Limitations of Use
Imiquimod cream has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy [see Use in Specific Populations].
Treatment with ZYCLARA Cream has not been studied for prevention or transmission of HPV.
The safety and efficacy of ZYCLARA Cream have not been established in the treatment of:
urethral, intra-vaginal, cervical, rectal or intra-anal human papilloma viral disease.
actinic keratosis when treated with more than one 2-cycle treatment course in the same area.
patients with xeroderma pigmentosum.
superficial basal cell carcinoma.
Published Studies Related to Zyclara (Imiquimod)
Comparison of imiquimod 5% cream versus radiotherapy as treatment for eyelid basal cell carcinoma. [2011.10]
BACKGROUND: To compare the efficacy, cosmesis and tolerance of two non-surgical treatments-imiquimod (IMQ) 5% cream and radiotherapy (RT)-to combat periocular nodular basal cell carcinoma (BCC)... CONCLUSIONS: IMQ and RT therapies are effective for treating eyelid nodular BCCs. Cosmesis and functional results were better with IMQ, while tolerability was higher with RT.
Comparison of topical 3% diclofenac sodium gel and 5% imiquimod cream for the treatment of actinic keratoses. [2011.07]
BACKGROUND: There is a wide spectrum of treatments available for actinic keratosis (AK). Topical diclofenac sodium and imiquimod are two topical treatments, which are noninvasive, easily applied, well-tolerated and effective. AIM: To compare the effects of topical 3% diclofenac sodium plus hyaluranon (DFS) gel, 5% imiquimod (IMQ) cream, and base cream (BC) in patients with AK... CONCLUSIONS: Although DFS and IMQ each had considerable efficacy in the treatment of AK, the efficacy of DFS seemed to decrease after cessation of treatment. (c) The Author(s). CED (c) 2011 British Association of Dermatologists.
Treatment of vulvar intraepithelial neoplasia with topical imiquimod: seven years median follow-up of a randomized clinical trial. [2011.04]
OBJECTIVE: Recently we reported on the efficacy of imiquimod for treating vulvar intraepithelial neoplasia (VIN) in a placebo-controlled, double-blinded randomized clinical trial (RCT). Four weeks after treatment, a complete response was observed in 35% of patients and a partial response in 46%. All complete responders remained disease-free at 12 months follow-up. In the current investigations, we assessed long-term follow-up at least 5 years after the initial RCT... CONCLUSIONS: In case of a complete response, imiquimod is effective in the long-term. Furthermore, patients with a long-term complete response had a significantly better global quality of life than patients who recurred after imiquimod treatment. Copyright (c) 2010 Elsevier Inc. All rights reserved.
Efficacy and safety of imiquimod versus podophyllotoxin in the treatment of anogenital warts. [2011.03]
BACKGROUND: 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... CONCLUSIONS: 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.
Complete clearance is sustained for at least 12 months after treatment of actinic keratoses of the face or balding scalp via daily dosing with imiquimod 3.75% or 2.5% cream. [2011.02]
OBJECTIVE: Assess long-term, sustained, complete clearance of actinic keratoses after treatment with imiquimod 3.75% or 2.5% cream using two two-week or three-week cycles of daily dosing... CONCLUSION: In subjects with a median of eight to nine baseline actinic keratoses who achieved complete clearance after treatment of the full face or balding scalp with topical imiquimod 3.75% cream, complete clearance of all lesions (baseline, recurrent or new) was sustained in >/= 40 percent of subjects for at least 14 months after the last dose. Clinicaltrials.gov identifier NCT00668733.
Clinical Trials Related to Zyclara (Imiquimod)
Study Comparing Imiquimod Cream, 3.75% to Zyclara� (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis [Recruiting]
To determine the comparability of the safety and efficacy of Imiquimod Cream, 3. 75% and
Zyclara (imiquimod) Cream, 3. 75% (the reference listed drug) in subjects with actinic
keratosis (AK) of the face or balding scalp. It will also be determined whether the
efficacy of each of the two active treatments is superior to that of the Vehicle cream.
Combination Therapy of Topical Imiquimod Plus Multipeptide Vaccination for Cutaneous Metastases of Melanoma [Recruiting]
The purpose of the study is to determine 1) the safety of administration of topical 5%
imiquimod cream with or without administration of a peptide-based vaccine in patients with
cutaneous metastases of melanoma and 2) evaluate whether topical imiquimod at sites of
melanoma metastasis, with or without vaccine, increases a) endothelial expression of
E-selectin and b) T cell infiltration.
Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy [Recruiting]
The purpose of this study is to explore the effect of treating actinic keratoses of the face
with imiquimod 3. 75% cream followed by photodynamic therapy in comparison to treatment with
Topical Imiquimod and Abraxane in Treating Patients With Advanced Breast Cancer [Recruiting]
This phase II trial is studying the side effects of giving topical imiquimod together with
Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) to see how well it works
in treating patients with advanced breast cancer. Biological therapies, such as imiquimod,
may stimulate the immune system to kill tumor cells. Drugs used in chemotherapy, such as
Abraxane, work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing. Giving imiquimod together with Abraxane may kill
more tumor cells.
Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy [Recruiting]
Actinic cheilitis is a common precancerous lesion of the lip. The purpose of this study is
to compare imiquimod 5% therapy and photodynamic therapy. The data will include effect data,
histology (skin analysis), epidemiological data and follow-up data.
Reports of Suspected Zyclara (Imiquimod) Side Effects
Influenza Like Illness (4),
DRY Skin (2),
Application Site Discolouration (1),
Oral Herpes (1),
Basal Cell Carcinoma (1), more >>
Page last updated: 2011-12-09