At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 320 enrolled
Drug / intervention
LEO 43204 Formulation 1 +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of Escalating Doses of Two LEO 43204 Formulations Applied Once Daily for Two Consecutive Days on Full Face or Approximately 250 cm2 (40 in2) on the Chest in Subjects With Actinic Keratosis
In Brief
A Phase 2 clinical trial evaluating LEO 43204 Formulation 1, LEO 43204 Formulation 2, and 6 other interventions for Actinic Keratosis. Completed, enrolled 320 participants across 25 sites in 2 countries.
Detailed Summary
Part 1: To identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once daily treatment for two consecutive days Part 2: To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulations
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 2013
Enrollment StartOct 2013
Primary CompletionNov 2014
TodayJul 2026
First PostedAug 14, 2013
Enrollment StartOct 1, 2013
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.9 years ago
Interventions
LEO 43204 Formulation 1drug
LEO 43204 Formulation 2drug
LEO 43204 Formulation 1 Dose Xdrug
LEO 43204 Formulation 1 Dose Ydrug
LEO 43204 Formulation 2 Dose XXdrug
LEO 43204 Formulation 2 Dose YYdrug
Placebo Formulation 1drug
Placebo Formulation 2drug