NCT00625157

Brief Summary

Lupus Erythematosus (LE) is an autoimmune disorder that includes a broad spectrum of clinical forms. One of these forms, Discoid Lupus Erythematosus (DLE) is a chronic disfiguring disease confined to the skin. The aim of this pivotal trial is to investigate the efficacy and safety of ASF-1096 cream 0.5% in the treatment of patients with DLE or SLE presenting newly developed discoid lesions.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
Last Updated

February 29, 2008

Status Verified

February 1, 2008

First QC Date

February 20, 2008

Last Update Submit

February 28, 2008

Conditions

Discoid Lupus Erythematosus

Study Arms (2)

1

EXPERIMENTAL
Drug: ASF 1096 0.5 % cream

2

PLACEBO COMPARATOR
Drug: ASF 1096 placebo cream

Interventions

ASF 1096 0.5 % creamDRUG
1
ASF 1096 placebo creamDRUG
2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A clinical diagnosis of either DLE or SLE
  • Histological results from biopsy confirming the diagnosis (biopsy can be taken at screening)
  • Is prepared to grant authorised persons access to the medical records
  • Has signed informed consent

You may not qualify if:

  • Has an active skin disease other than DLE or another progressive or serious disease that interferes with the study outcome
  • Has scarring at the target lesion
  • Systemic treatment of SLE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gregor Jemec

Roskilde Hospital, Denmark

Location

MeSH Terms

Conditions

Lupus Erythematosus, Discoid

Condition Hierarchy (Ancestors)

Lupus Erythematosus, CutaneousConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 20, 2008

First Posted

February 28, 2008

Last Updated

February 29, 2008

Record last verified: 2008-02

Locations

DK(1)