NCT00987246

Study on the Efficacy of LAS41005 in the Treatment of Actinic Keratosis

Study on the Efficacy of LAS41005 Compared to Placebo and to LAS106521 in the Treatment of Actinic Keratosis Grade I to II

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 470 (actual)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo and to LAS106521 in actinic keratosis (AK).

Detailed description

To investigate as primary objective: * Superiority to placebo and non-inferiority to LAS106521 measured by histological clearance of one predefined target lesion; To investigate as secondary objective: * Superiority to LAS106521 * Improvement of treated lesions (lesion response) * Assessment of tolerability and safety by physicians global assessment score (PGA, PGT) * Patient's assessment of tolerability and efficacy and patient's compliance

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Placebo Gel	Topical
DRUG	LAS41005	Topical
DRUG	LAS106521	Topical

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2009-09-30
• Last updated: 2015-07-28

Locations

40 sites across 1 country: Germany