NCT00625521

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

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2006

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, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
8 months until next milestone

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

Keywords

Discoid lupus erythematosus

Outcome Measures

Primary Outcomes (1)

  • Safety profile, CLASI score, GIA and GPA.

Study Arms (2)

1

EXPERIMENTAL

Drug: ASF 1096 0.5 % cream applied twice daily

Drug: ASF 1096 0.5 % cream applied twice daily

2

PLACEBO COMPARATOR

Cream vehicle for ASF 1096 cream applied twice daily

Drug: Cream vehicle for ASF 1096 cream applied twice daily

Interventions

ASF 1096 0.5 % cream applied twice dailyDRUG
1
Cream vehicle for ASF 1096 cream applied twice dailyDRUG
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)

Filippa Nyberg

Danderyd Stockholm, Sweden

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
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 20, 2008

First Posted

February 28, 2008

Study Start

November 1, 2006

Study Completion

July 1, 2007

Last Updated

February 29, 2008

Record last verified: 2008-02

Locations

SE(1)