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

Phase 2

Completed

• Conditions: Eczema
• Interventions: Drug: LAS41003; Drug: LAS189962; Drug: LAS189961

• Registration Number: NCT01020994
• Lead Sponsor: Almirall, S.A.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-25
• Study First Posted: 2009-11-26
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-08
• Last Update Posted: 2010-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Clinically diagnosed super-infected or impetiginized eczema

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAS41003	LAS41003	-
LAS189962	LAS189962	-
LAS189961	LAS189961	-

Primary Outcome Measures

Name	Time	Method
Combination of clinical and microbial treatment success	Day 14

Secondary Outcome Measures

Name	Time	Method
Safety:Physical examination at EoT, AEs/SAEs during the entire study	2 weeks

Trial Locations

Locations (1)

Investigational Site; 🇩🇪 Bochum, Germany