ArticleThe Journal of clinical and aesthetic dermatology2009
Safety and Efficacy of Multiple 16-week Courses of Topical Imiquimod for the Treatment of Large Areas of Skin Involved with Actinic Keratoses.
Article in The Journal of clinical and aesthetic dermatology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00116649 (Open-Label Safety and Pharmacokinetic Study of AldaraTM), which is not on this map. Cited by 6 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
6 citing papers in PubMed, 7 citations in OpenAlex.
- Topical TLR7 agonist imiquimod can induce immune-mediated rejection of skin metastases in patients with breast cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2012Trial
- Imiquimod - A toll like receptor 7 agonist - Is an ideal option for management of COVID 19.Environmental research · 2020Article
- Therapeutic Effects of Methanol Extract fromJournal of immunology research · 2017Article
- Comprehensive management of actinic keratoses: practical integration of available therapies with a review of a newer treatment approach.The Journal of clinical and aesthetic dermatology · 2014Article
- Trial watch: FDA-approved Toll-like receptor agonists for cancer therapy.Oncoimmunology · 2012Article
- Histologic Clearance of a Giant Cutaneous Squamous Cell Carcinoma with Imiquimod 5% Cream: A Case Report.Case reports in dermatologyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveSafety of multiple 16-week courses of imiquimod applied to large areas (>25 cm(2)) of skin with actinic keratoses.
designSubjects applied 1 to 6 packets two times per week for 16 weeks; if actinic keratoses were persistent at two months post-treatment, up to two additional courses could be administered within the 18-month study period.
settingMulticenter, outpatient.
participantsAdults with >/=4 actinic keratoses on the head, torso, and/or extremities. MEASUREMENTS: Treatment discontinuations, adverse events, lesion counts.
resultsSafety analyses included 551 subjects. At baseline, mean overall treatment area was 625+/-1114cm(2). Overall, the mean days on study was 467+/-157, and the mean exposure 215+/-133 packets with 155, 150, and 250 subjects receiving 1, 2, or 3 treatment courses, respectively. Of the 155 subjects (28.1%) who did not complete the study, 20 (3.6%) and 9 (1.6%) were discontinued for adverse events and local skin reactions, respectively. Adverse events related to study drug were reported by 40.5 percent of subjects. The local skin reactions rated as severe reported by the most subjects were erythema (31.4%), flaking/scaling/drying (23.8%), and scabbing/crusting (22.0%). For 525 subjects with analyzable lesion data, the mean baseline lesion count was 45.5+/-2.4. Overall reduction in target lesion count was 80.2 percent (p<0.0001, 95% CI 77.2-83.3%), with overall complete clearance rate of 36.4 percent and partial clearance rate (>/=75% reduction) of 68.6 percent.
conclusionMultiple 16-week courses of imiquimod to treat actinic keratoses were well tolerated and significantly decreased lesions in subjects with extensive actinic keratoses.
Identifiers
20729935PMC2923947W2186565633What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.