At a glance
ClinicalIndex Comparison Record- ✓Age at least 18 years
- ✓Treatment area greater than 25 cm² containing at least 4 actinic keratosis lesions
- ✕Any skin condition in the treatment area that may be worsened by imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema)
- ✕Prior specific treatments/medications in the treatment area(s) within the designated time period before study initiation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating imiquimod cream for Keratosis. Completed, enrolled 551 participants across 32 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
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