Efficacy and Safety of LAS41003 in the Treatment of Superficial Infected Eczema - Full Text View

Purpose

The aim of the study is to determine the efficacy and safety of topical application of LAS41003 in comparison to LAS189962 and LAS189961 in the treatment of superinfected eczema.

Condition	Intervention	Phase
Eczema	Drug: LAS41003 Drug: LAS189962 Drug: LAS189961	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Explorative, Double-blind, Randomized, Controlled Multi-center Phase II Study to Evaluate the Efficacy and Safety of Topically Applied LAS41003 Once Daily Versus LAS189962 and LAS189961 in the Treatment of Superficial Infected Eczema

Resource links provided by NLM:

MedlinePlus related topics: Eczema

U.S. FDA Resources

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

Primary Outcome Measures:

Combination of clinical and microbial treatment success [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety:Physical examination at EoT, AEs/SAEs during the entire study [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	150
Study Start Date:	November 2009
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LAS41003	Drug: LAS41003 Once daily, topically
Active Comparator: LAS189962	Drug: LAS189962 Once daily, topically
Active Comparator: LAS189961	Drug: LAS189961 Once daily, topically

Eligibility


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

Criteria

Inclusion Criteria:

Clinically diagnosed super-infected or impetiginized eczema

Exclusion Criteria:

Patients who have general signs of systemic infections like fever, malaise, lymphangitis or swollen lymph nodes and / or need systemic antibiotic treatment
Patients who have a bacterial skin infection which, due to depth and severity, could not be appropriately treated with a topical antimicrobial or antiseptic medication
Diagnose of the following disease:
- Known active tuberculosis or any history of past tuberculosis of skin
- Suspected or proven parasitic infection of the treatment site (e.g. scabies)
- Psoriasis
- Suspected or proven viral infection of skin (e.g. Herpes)
Localization of the superficial infected eczema:
- Palms of the hands
- Sole of a foot
- Face
Have received any topical treatment with antibiotics, antimycotics, immunomodulators and corticosteroid preparations within the last 2 weeks before treatment with IMP

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020994

Locations


Germany
Investigational Site
Bochum, Germany

Sponsors and Collaborators

Almirall, S.A.

Investigators


Study Director:	Christoph Willers, MD, MBA	Almirall Hermal GmbH

More Information

No publications provided


Responsible Party:	Head of Global Clinical Development, Almirall Hermal GmbH
ClinicalTrials.gov Identifier:	NCT01020994 History of Changes
Other Study ID Numbers:	H 552 000 - 0911, EudraCT: 2009-011931-11
Study First Received:	November 24, 2009
Last Updated:	July 8, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Almirall, S.A.:


Superficial infected eczema Superinfected eczema

Additional relevant MeSH terms:


Eczema Dermatitis Skin Diseases Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on February 27, 2015