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Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions

NCT ID: NCT00625521

Last Updated: 2008-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Discoid Lupus Erythematosus

Keywords

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Discoid lupus erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Drug: ASF 1096 0.5 % cream applied twice daily

Group Type EXPERIMENTAL

ASF 1096 0.5 % cream applied twice daily

Intervention Type DRUG

2

Cream vehicle for ASF 1096 cream applied twice daily

Group Type PLACEBO_COMPARATOR

Cream vehicle for ASF 1096 cream applied twice daily

Intervention Type DRUG

Interventions

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ASF 1096 0.5 % cream applied twice daily

Intervention Type DRUG

Cream vehicle for ASF 1096 cream applied twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astion Pharma A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Astion Pharma A/S

Locations

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Filippa Nyberg

Danderyd Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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ASF1096-201

Identifier Type: -

Identifier Source: org_study_id