Abstract | BACKGROUND: OBJECTIVES: To evaluate imiquimod vs. vehicle applied three times a week for 4 weeks in one or two courses of treatment for AK on the face or balding scalp. PATIENTS AND METHODS: Patients diagnosed with AK were enrolled in this multicentre, vehicle-controlled, double-blind study conducted in Europe. Twenty study centres enrolled a total of 259 patients in this study. Patients applied the study drug for 4 weeks, entered a 4-week rest period and if they did not have complete clearance, they then entered a second course of treatment. RESULTS: Patients in the imiquimod group had an overall complete clearance rate of 55.0% (71/129) vs. a rate of 2.3% (3/130) for the vehicle group. There was a high rate of agreement between the clinical assessment and histological findings with respect to AK lesion clearance. At both 8-week post-treatment visits, the negative predictive value of the investigator assessment was 92.2% for clinical assessments vs. histological results. CONCLUSIONS: A 4-week course of treatment with three times weekly dosing of imiquimod 5% cream, with a repeated course of treatment for those patients who fail to clear after the first course of treatment, is a safe and effective treatment for AK. The overall complete clearance rate (complete clearance after either course 1 or course 2) is comparable to the 16-week treatment regimen, while decreasing drug exposure to the patient and decreasing the overall treatment time.
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Authors | A Alomar, J Bichel, S McRae |
Journal | The British journal of dermatology
(Br J Dermatol)
Vol. 157
Issue 1
Pg. 133-41
(Jul 2007)
ISSN: 0007-0963 [Print] England |
PMID | 17501955
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Aminoquinolines
- Interferon Inducers
- Ointments
- Imiquimod
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Topics |
- Aged
- Aged, 80 and over
- Aminoquinolines
(administration & dosage, adverse effects)
- Double-Blind Method
- Female
- Humans
- Imiquimod
- Interferon Inducers
(administration & dosage, adverse effects)
- Keratosis
(drug therapy)
- Male
- Middle Aged
- Ointments
- Photosensitivity Disorders
(drug therapy)
- Scalp Dermatoses
(drug therapy)
- Skin Neoplasms
(chemically induced)
- Sunlight
(adverse effects)
- Treatment Outcome
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