Efficacy and Safety Study of LAS41007 in the Treatment of Actinic Keratosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Actinic Keratosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LAS41007 o.d.

Once daily

Group Type EXPERIMENTAL

LAS41007 o.d.

Intervention Type DRUG

Once daily, topical application

LAS41007 b.i.d.

Twice daily

Group Type EXPERIMENTAL

LAS41007 b.i.d.

Intervention Type DRUG

Twice daily, topical application

LAS106521

Group Type ACTIVE_COMPARATOR

LAS106521

Intervention Type DRUG

Twice daily, topical application

Interventions

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LAS41007 o.d.

Once daily, topical application

Intervention Type DRUG

LAS41007 b.i.d.

Twice daily, topical application

Intervention Type DRUG

LAS106521

Twice daily, topical application

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No