We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Efficacy Endpoints in Clinical Trials in Actinic Keratosis.
- Authors
Skov, Torsten; Stockfleth, Eggert; Szeimies, Rolf-Markus; Berman, Brian
- Abstract
Introduction: Actinic keratosis is regarded as a chronic disease of the skin and, although fluctuating, is chronically progressive. Approval of new products for the treatment of actinic keratosis requires the use of a standard methodology in clinical trials which emphasize complete clearance of all actinic keratoses in a treatment field in a defined time span and the evaluation of long-term efficacy in terms of recurrence rate among completely cleared patients.Methods: Analysis of data from six previously published clinical trials in patients with actinic keratosis.Results: There was poor agreement over a period of 1 month in the complete clearance endpoint. This variation in assessment renders recurrence in cleared patients invalid as the estimate of long-term efficacy. Furthermore, complete clearance was shown to depend heavily on the number of baseline actinic keratoses.Conclusion: The main endpoints presently in use for the assessment of short- and long-term efficacy of actinic keratosis field-directed therapy, namely, complete clearance and recurrence rate, are obsolete and should be replaced by the percentage reduction in actinic keratosis count or the absolute actinic keratosis count.Funding: LEO Pharma A/S.
- Subjects
ACTINIC keratosis; DRUG approval; CLINICAL trials; TREATMENT effectiveness; DISEASE relapse; THERAPEUTICS
- Publication
Dermatology & Therapy, 2018, Vol 8, Issue 3, p425
- ISSN
2193-8210
- Publication type
Article
- DOI
10.1007/s13555-018-0247-0