Overview

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

Status:
Completed

Trial end date:
2009-06-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Almirall, S.A.

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)