Study on the Efficacy of LAS41005 Compared to Placebo and to LAS106521 in the Treatment of Actinic Keratosis Grade I to II
18 Years
85 Years
Both
Actinic Keratosis
Trial Information
Study on the Efficacy of LAS41005 Compared to Placebo and to LAS106521 in the Treatment of Actinic Keratosis Grade I to II
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
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Histological status of AK target lesion
Outcome Time Frame:
Day 140
Safety Issue:
No
Principal Investigator
Christoph Willers, MD, MBA
Investigator Role:
Study Director
Investigator Affiliation:
Almirall Hermal GmbH
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
H 1005 6002 - 0702
NCT ID:
NCT00987246
Start Date:
June 2008
Completion Date:
June 2009
Related Keywords:
- Actinic Keratosis
- Actinic Keratosis
- AK
- NMSC
- Combination
- Keratosis
- Keratosis, Actinic
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