Double-blind, Randomized, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Topically Applied LAS41007 Once Daily and LAS41007 Twice Daily Versus LAS106521 Gel Twice Daily in the Treatment of Actinic Keratosis Grade I to II

Almirall, S.A.1 site in 1 country100 target enrollmentAugust 2009

ConditionsActinic Keratosis

InterventionsLAS41007 o.d.LAS41007 b.i.d.LAS106521

DrugsLAS41007 o.d.LAS41007 b.i.d.LAS106521

Overview

Phase: Phase 2
Intervention: LAS41007 o.d.
Conditions: Actinic Keratosis
Sponsor: Almirall, S.A.
Enrollment: 100
Locations: 1
Primary Endpoint: Histological clearance of one pre-selected target lesion
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to determine the efficacy, safety and tolerability of either a once or twice daily topical application of LAS41007 compared to a twice daily application of LAS106521 in the treatment of actinic keratosis.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

February 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Almirall, S.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•At least 4-10 clinically assessed actinic keratosis grade I to II (according to Olsen et al, 1991) in the face/forehead and/or on the bald scalp
•The diameter of each AK target lesion is not less than 0.5 cm and not greater than 1.5 cm
•The target lesions must be located in overall 2 treatment areas with a size of 25 cm2 per treatment area

Exclusion Criteria

•Have evidence of clinically significant or unstable medical conditions such as:
•metastatic tumor or tumor with high probability of metastatic spread
•heart failure (NYHA class III or higher)
•immunosuppressive disorder (e.g. HIV)
•hematologic, hepatic, renal, neurologic or endocrine disorder.
•collagen-vascular disorder (e.g. cerebrovascular disorder or other bleedings).
•gastrointestinal disorder (e.g. active ulcera or history of recurrent peptic ulcera or hemorrhage)
•Suffer from paresthesia in the treatment areas
•Show Cornu cutaneum of the skin and/or hypertrophic AK lesions in the treatment areas