Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Chiari Malformation Type 2

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Imiquimod

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

Aldara® (imiquimod) cream, 5% supplied in 250 mg single-use packets.

imiquimod 5% cream applied in doses ranging from one packet (12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles

imiquimod cream

Sharon Levy, MD

Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso, and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The secondary objective is to evaluate the effectiveness of treatment with imiquimod in people with large surface areas of AK.

This was a Phase 4, open-label, single-arm, multicenter study in male and female subjects aged 18 years or older with clinically diagnosed AK lesions, conducted at 31 investigational sites in the United States.

This study assessed the safety of imiquimod as a treatment for AK applied in doses ranging from one packet 12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles, depending upon treatment success and AK lesion recurrence. Eligible subjects applied imiquimod 5% cream prior to normal sleeping hours 2 days per week to at least 4 clinically typical, visible, discrete, nonhypertrophic AK lesions in contiguous or noncontiguous treatment areas totaling greater than 25 cm2 at baseline. Multiple treatment areas could be exposed (i.e., head, torso and/or extremities), with the number of packets determined by the investigator but not to exceed one packet for each 25 cm2 treatment area, up to a maximum of 6 packets per dose. In each treatment cycle, dosing was to continue for 16 weeks (approximately 4 months), as instructed by the investigator, followed by a 2-month, treatment-free follow-up period.

Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis

Open-Label Safety and Pharmacokinetic Study of AldaraTM (Imiquimod) Cream, 5% for One, Two, or Three Treatment Cycles to Surface Areas Greater Than 25 cm2 With Actinic Keratosis

Adverse events that occurred between the first day of exposure to the study cream and study discharge were summarized. Adverse events - any untoward medical occurrence in a subject that is temporally related to protocol procedures, including the administration of a pharmaceutical product at any dose, but which does not necessarily have a causal relationship with the treatment.

Percent reduction = (total baseline AK lesion count - total final lesion count)x100/ total baseline AK lesion count

Graceway Pharmaceuticals, LLC

Sharon Levy, MD VP Product Development

Reporting of AEs by subjects was recorded. Local skin reactions (LSRs) in the treatment areas were also evaluated. These were erythema, edema, weeping/ exudate, vesicles, erosion/ulceration, flaking/scaling/dryness, and scabbing/crusting. Other skin-related reactions not listed, such as burning, itching, bleeding, etc., were documented as AEs.

Aldara (Imiquimod) Cream

Age, Categorical

Age Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Baseline actinic keratosis lesion count

There were 551 subjects in the Safety population, which consisted of the enrolled subjects who received at least one dose of study medication.

Number of Participants Who Experienced an Adverse Event

The ITT population (n=526) consisted of the Safety population who had at least one scheduled primary efficacy assessment at a post-baseline visit

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis	NCT00116649	Keratosis	imiquimod cream	18 Years -	Graceway Pharmaceuticals, LLC
Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis	NCT00116649	Keratosis	imiquimod cream	18 Years -	Graceway Pharmaceuticals, LLC

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