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Home » Drug Information » FDA Approved Drugs » 2010
Medical Areas: Dermatology

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Zyclara (imiquimod)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Graceway
Approval Status: Approved March 2010
Treatment Area: actinic keratoses

General Information

Zyclara contains the active ingredient imiquimod, which belongs to a class of drugs called immune response modifiers (IRM's). IRM's have shown both antitumor and antiviral activity in vivo. The exact mechanism of action in which imiquimod activates the immune system is not yet known. However, it is known that imiquimod activates immune cells through the toll-like receptor 7, commonly involved in pathogen recognition, on the cell surface.

Zyclara is specifically approved for the topical treatment of clinically typical visible or palpable actinic keratoses of the full face or balding scalp in immunocompetent adults.

Zyclara is supplied as a cream 3.75% designed for topical administration. Zyclara cream should be applied once daily before bedtime to the skin of the affected area (either the face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period. The cream should be applied as a thin film to the entire treatment area and rubbed in until the cream is no longer visible. Up to 2 packets of Zyclara Cream may be applied to the treatment area at each application. It should be left on the skin for approximately 8 hours, after which time the cream should be removed by washing the area with mild soap and water.

Clinical Results

FDA Approval
The FDA approval of Zyclara Cream was based on two double-blind, randomized, vehicle-controlled clinical studies. The studies enrolled 319 adults subjects with 5-20 typical visible or palpable AK lesions of the face or scalp. Zyclara Cream was applied to either the entire face (excluding ears) or balding scalp once daily for two 2-week treatment cycles separated by a 2-week no-treatment period. On a scheduled dosing day, up to two packets of the study cream were applied to the entire treatment area prior to normal sleeping hours and left on for approximately 8 hours. The subjects continued in the study for an 8- week follow-up period during which they returned for clinical observations and safety monitoring. Efficacy was assessed by AK lesion counts at the 8-week post-treatment visit. All AKs in the treatment area were counted, including baseline lesions as well as lesions which appeared during therapy. Complete clearance required absence of any lesions including those that appeared during therapy in the treatment area while partial clearance was defined as the percentage of subjects in whom the number of baseline AKs was reduced by 75% or more. The results are as follows:
Rates of Subject with Complete Clearance at 8 Weeks Post Treatment
Study One: Zyclara Cream: 25.9% vs. placebo: 2.5%. Study Two: Zyclara Cream: 45.6% vs. placebo: 10.1%.
Rate of Subjects with Partial Clearance (>75%) at 8 Weeks Post Treatment:
Study One: Zyclara Cream: 45.7% vs. placebo 18.8%. Study Two: Zyclara Cream: 73.4% vs. placebo: 26.6%.

Ongoing Study Commitments

  • Graceway has agreed to conduct a randomized crossover clinical trial (Zyclara Cream, 3.75% vs. vehicle) in patients with actinic keratosis to detect treatment-related change in atrial ectopy.
    Final Protocol Submission: September 2010
    Trial Completion Date: September 2011
    Final Report Submission: March 2012

Side Effects

Adverse events associated with Zyclara Cream may include, but are not limited to, the following:

  • local skin reactions
  • erythema
  • edema weeping/exudate
  • flaking/scaling/dryness
  • scabbing/crusting
  • erosion/ulceration

Mechanism of Action

Zyclara contains the active ingredient imiquimod, which belongs to a class of drugs called immune response modifiers (IRM's). IRM's have shown both antitumor and antiviral activity in vivo. The exact mechanism of action in which imiquimod activates the immune system is not yet known. However, it is known that imiquimod activates immune cells through the toll-like receptor 7, commonly involved in pathogen recognition, on the cell surface.

Additional Information

For additional information regarding Zyclara Cream or actinic keratoses, please visit the Zyclara web page.