Efficacy and Safety of LAS41003 in the Treatment of Super... | NCT01020994

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

NCT01020994

Sponsor

Almirall, S.A.

Status

Completed

Last Update Posted

Jul 9, 2010Estimated

Enrollment

150Estimated

Phase

Phase 2

Conditions

Eczema

Interventions

LAS41003
LAS189962
LAS189961

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT: 2009-011931-11

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Nov 24, 2009

First Submission Date that Met QC Criteria

Nov 25, 2009

First Posted Date

Nov 26, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2010

Last Update Posted Date

Jul 9, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
LAS41003	Experimental	Drug: LAS41003
LAS189962	Active Comparator	Drug: LAS189962
LAS189961	Active Comparator	Drug: LAS189961

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LAS41003	Drug	Once daily, topically	LAS41003
LAS189962

Measure	Description	Time Frame
Combination of clinical and microbial treatment success		Day 14

Measure	Description	Time Frame
Safety:Physical examination at EoT, AEs/SAEs during the entire study		2 weeks

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous