Conditions: Actinic Keratosis
Keywords: Actinic keratosis, patients, topical, lesion count, clearance rate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 82
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications arm 2: LFX453 0.15% liquid crystal cream (LCC) Twice daily applications arm 3: Vehicle to nanomedicinal cream (NMC) Twice daily applications arm 4: Vehicle to liquid crystal cream (LCC) Twice daily applications arm 5: Aldara cream 3 applications per week

Interventions: intervention 1: Investigational Treatment intervention 2: Active comparator
Intervention descriptions: intervention 1: Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up. intervention 2: Topical treatment with Aldara 3 times per week. The group will be open-label, but however blinded to the efficacy assessor, and followed by 8 week treatment free follow-up.

Protocol document: