- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00625157
Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions (2)
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 (2)
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
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Roskilde Hospital, Denmark
- Gregor Jemec
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
|
Placebo Comparator: 2
|
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASF1096-203
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
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Florida Academic Dermatology CentersUnknownDiscoid Lupus Erythematosus (DLE)United States
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LEO PharmaTerminatedDiscoid Lupus ErythematosusUnited States, France, Germany, Denmark
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Al-Azhar UniversityCompleted
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University of RochesterIncyte CorporationCompletedDiscoid Lupus ErythematosusUnited States
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Massachusetts General HospitalNovartisWithdrawnDiscoid Lupus ErythematosusUnited States
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CelgeneTerminatedDiscoid LupusUnited States
-
AmgenTerminatedSystemic Lupus Erythematosus | Cutaneous Lupus | Lupus | Discoid LupusUnited States
-
AmgenCompleted
-
NYU Langone HealthCelgene CorporationCompletedDiscoid Lupus ErythematosusUnited States
-
The Cleveland ClinicWithdrawnDiscoid Lupus Erthematosus of the ScalpUnited States
Clinical Trials on ASF 1096 0.5 % cream
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Astion Pharma A/SCompletedDiscoid Lupus ErythematosusSweden
-
GlaxoSmithKlineCompletedDermatitis, AtopicUnited States, Canada, Japan
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GlaxoSmithKlineCompletedPsoriasisUnited States, Canada, Japan
-
AstraZenecaCompleted
-
Arcutis Biotherapeutics, Inc.CompletedPsoriasisCanada, United States
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Amazentis SAproDERM GmbHCompleted
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Amazentis SAproDERM GmbHCompletedErythema | Skin Inflammation | Sun Damaged SkinGermany
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Cara Therapeutics, Inc.Terminated
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Betta Pharmaceuticals Co., Ltd.Tigermed Consulting Co., LtdCompleted
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Rabin Medical CenterUnknown