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

February 28, 2008 updated by: Astion Pharma A/S

Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Patients With Newly Developed Discoid Lupus Erythematosus (DLE) Lesions. An International Multi-Centre Clinical Phase 2, Placebo Controlled and Double Blind Proof of Concept Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Danderyd Stockholm, Sweden
        • Filippa Nyberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: ASF 1096 0.5 % cream applied twice daily
Drug: ASF 1096 0.5 % cream applied twice daily
PLACEBO_COMPARATOR: 2
Cream vehicle for ASF 1096 cream applied twice daily
Drug: Cream vehicle for ASF 1096 cream applied twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety profile, CLASI score, GIA and GPA.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astion Pharma A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

February 27, 2008

First Posted (ESTIMATE)

February 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 29, 2008

Last Update Submitted That Met QC Criteria

February 28, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASF1096-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Discoid Lupus Erythematosus

Clinical Trials on ASF 1096 0.5 % cream applied twice daily

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe