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22-10-2020

Clinical Trials Experience: External Genital Warts

In controlled clinical trials for genital warts, the most frequently reported adverse reactions were local skin and application site reactions.

Some subjects also reported systemic reactions. Overall, 1.2% (4/327) of the subjects discontinued due to local skin/application site reactions. Here you can buy imiquimod 5% cream low price The incidence and severity of local skin reactions during controlled clinical trials are shown in Table 8.

Remote site skin reactions were also reported. The severe remote site skin reactions reported for females were erythema (3%), ulceration (2%), and edema (1%); and for males, erosion (2%), and erythema, edema, induration, and excoriation/flaking (each 1%).

Selected adverse reactions judged to be probably or possibly related to ALDARA Cream are listed in Table 9.

Application Site Disorders: Application Site Reactions; Adverse reactions judged to be possibly or probably related to ALDARA Cream and reported by more than 1% of subjects included: Application Site Disorders: burning, hypopigmentation, irritation, itching, pain, rash, sensitivity, soreness, stinging, tenderness; Remote Site Reactions: bleeding, burning, itching, pain, tenderness, tinea cruris; Body as a Whole: fatigue, fever, influenza-like symptoms; Central and Peripheral Nervous System Disorders: headache; Gastrointestinal System Disorders: diarrhea. Musculoskeletal System Disorders: myalgia.

Cryotherapy

Cryotherapy involves freezing the spots with liquid nitrogen to remove them. Each spot is frozen for 5-10 seconds, so that a layer of ice forms over the spot and surrounding skin.

You may need several sessions of cryotherapy before each spot clears completely. You'll need to wait 2 to 3 weeks between each treatment session.

How Supplied/Storage and Handling

Imiquimod Cream, 3.75% is white to faintly yellow in color and supplied as white plastic 30 mL pump bottles, equipped with a white cap. The 7.5 g pump delivers no fewer than 28 full actuations.

7.5 g of the 3.75% cream, NDC 0093-3133-31.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Avoid freezing.

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