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

Almirall

Status and phase: Completed; Phase 2

Conditions: Eczema

Treatments: Drug: LAS189962; Drug: LAS41003; Drug: LAS189961

Study type: Interventional

Funder types: Industry

Identifiers

NCT01020994

H 552 000 - 0911

EudraCT: 2009-011931-11

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups

LAS41003

Experimental group

Treatment:

Drug: LAS41003

LAS189962

Active Comparator group

Treatment:

Drug: LAS189962

LAS189961

Active Comparator group

Treatment:

Drug: LAS189961