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

Primary Purpose

Discoid Lupus Erythematosus

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
ASF 1096 0.5 % cream applied twice daily
Cream vehicle for ASF 1096 cream applied twice daily
Sponsored by
Astion Pharma A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Discoid Lupus Erythematosus focused on measuring Discoid lupus erythematosus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Filippa Nyberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Drug: ASF 1096 0.5 % cream applied twice daily

Cream vehicle for ASF 1096 cream applied twice daily

Outcomes

Primary Outcome Measures

Safety profile, CLASI score, GIA and GPA.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2008
Last Updated
February 28, 2008
Sponsor
Astion Pharma A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00625521
Brief Title
Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Astion Pharma A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discoid Lupus Erythematosus
Keywords
Discoid lupus erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Drug: ASF 1096 0.5 % cream applied twice daily
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Cream vehicle for ASF 1096 cream applied twice daily
Intervention Type
Drug
Intervention Name(s)
ASF 1096 0.5 % cream applied twice daily
Intervention Type
Drug
Intervention Name(s)
Cream vehicle for ASF 1096 cream applied twice daily
Primary Outcome Measure Information:
Title
Safety profile, CLASI score, GIA and GPA.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Filippa Nyberg
City
Danderyd Stockholm
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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