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

Almirall

Status and phase

Completed

Phase 3

Conditions

Actinic Keratosis

Treatments

Drug: Placebo Gel

Drug: LAS106521

Drug: LAS41005

Study type

Interventional

Funder types

Industry

Identifiers

H 1005 6002 - 0702

EudraCT: 2007-003889-18

Details and patient eligibility

About

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

Full 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

Enrollment

470 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

Have at least 4 but not more than 10 clinically confirmed AK target lesions of mild to moderate intensity within the face/forehead or bald scalp (excluding eyelids, lips, and mucosa), i.e. actinic keratosis grade I and II according to Olsen EA et al. 1991
Woman of childbearing potential are allowed to participate in this study only if they use a highly effective method of contraception

Main Exclusion Criteria:

Have received effective treatment of AK in the three months preceding this clinical trial
Have known hypersensitivity to LAS41005 or LAS106521
Have currently other malignant or benign tumors of the skin within the treatment area (e.g. malignant melanoma, basal cell carcinoma, squamous cell carcinoma)
Patient's taking phenytoin
Show cornu cutaneum like alterations of the skin in the face or the bald scalp (target area)