Efficacy and Safety Study of LAS41007 in the Treatment of Actinic Keratosis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Actinic Keratosis	Drug: LAS41007 o.d. Drug: LAS41007 b.i.d. Drug: LAS106521	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Further study details as provided by Almirall, S.A.:

Primary Outcome Measures:

Histological clearance of one pre-selected target lesion [ Time Frame: Day 120 ] [ Designated as safety issue: No ]
Complete clinical clearance of all target lesions in the treatment areas [ Time Frame: Day 120 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physician's Global Tolerability Assessment (PGT) [ Time Frame: Day 120 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	August 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LAS41007 o.d. Once daily	Drug: LAS41007 o.d. Once daily, topical application
Experimental: LAS41007 b.i.d. Twice daily	Drug: LAS41007 b.i.d. Twice daily, topical application
Active Comparator: LAS106521	Drug: LAS106521 Twice daily, topical application

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991861

Locations

Germany
Investigational Site
Hamburg, Germany

Sponsors and Collaborators

Almirall, S.A.

Investigators

Study Director:

Christoph Willers, MD, MBA

Almirall Hermal GmbH

More Information

Additional Information:

Almirall Corporate Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Head of Global Clinical Development, Almirall Hermal GmbH, Germany
ClinicalTrials.gov Identifier:	NCT00991861 History of Changes
Other Study ID Numbers:	H 569 000 - 0908, EudraCT: 2009-012063-33
Study First Received:	October 7, 2009
Last Updated:	July 9, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Almirall, S.A.:

Actinic Keratosis
AK
NMSC

Additional relevant MeSH terms:

Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013