NCT01020994

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 9, 2010

Status Verified

July 1, 2010

Enrollment Period

7 months

First QC Date

November 24, 2009

Last Update Submit

July 8, 2010

Conditions

Eczema

Keywords

Superficial infected eczemaSuperinfected eczema

Outcome Measures

Primary Outcomes (1)

  • Combination of clinical and microbial treatment success

    Day 14

Secondary Outcomes (1)

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

    2 weeks

Study Arms (3)

LAS41003

EXPERIMENTAL
Drug: LAS41003

LAS189962

ACTIVE COMPARATOR
Drug: LAS189962

LAS189961

ACTIVE COMPARATOR
Drug: LAS189961

Interventions

LAS41003DRUG

Once daily, topically

LAS41003
LAS189962DRUG

Once daily, topically

LAS189962
LAS189961DRUG

Once daily, topically

LAS189961

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically diagnosed super-infected or impetiginized eczema

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site

Bochum, Germany

Location

MeSH Terms

Conditions

Eczema

Interventions

octenidine

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Christoph Willers, MD, MBA

    Almirall Hermal GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 26, 2009

Study Start

November 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 9, 2010

Record last verified: 2010-07

Locations

DE(1)