drugset / Trial / NCT02404389
Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized, vehicle controlled, active comparator, parallel group, study with a total duration of 24 weeks including screening and follow-up. Study drug is applied topically for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. Assessors of study endpoints are blinded to treatment allocation.
Timeline
- Start
- 2015-03-05
- Primary completion
- 2016-01-27
- Completion
- 2016-01-27
Outcome
Missed primary endpoint
registry LFX453 0.1% NMC vs Combined Vehicle; p = 0.515; Mean Difference (Net) 0.00 (90% CI -0.12 to 0.12) NCT02404389 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Imiquimod | Other / unclassified | — | Topical |
| Subject | LFX453 | Unknown | 0.1 % | Topical |
| Subject | LFX453 | Unknown | 0.15 % | Topical |