Last reviewed · How we verify
Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2 trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel
Details
| Lead sponsor | LEO Pharma |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 266 |
| Start date | 2014-01 |
| Completion | 2014-07 |
Conditions
- Actinic Keratosis
Interventions
- ingenol mebutate
- Placebo
Primary outcomes
- Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs) — At Week 8
Complete clearance of AKs at Week 8 was defined as a 100% reduction from baseline in number of AKs. The table presents the mean across 1000 multiple imputations. Missing values for AK count were imputed sequentially from a negative binomial regression model with treatment group, AK counts at the previous visit, and analysis site as covariates and log baseline AK count as offset.
Countries
United States