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Completed

NCT Number: NCT01020994

Efficacy and Safety of LAS41003 in the Treatment of Superficial Infected Eczema

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.

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Key information

Conditions

Eczema Dermatitis Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site

Bochum, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LAS41003

Drug

Once daily, topically

LAS189962

Drug

Once daily, topically

LAS189961

Drug

Once daily, topically

Primary outcomes

  1. Combination of clinical and microbial treatment success

    Time frame: Day 14

Secondary outcomes

  1. Safety:Physical examination at EoT, AEs/SAEs during the entire study

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 26, 2009
Registry last updated
Jul 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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