Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230373
Status:
WITHDRAWN
Last Update Posted:
2015-04-23
First Post:
2005-09-28
Brief Title:
Imiquimod 5 Cream in Plaque-type Morphea A Pilot Prospective Open-label Study
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Evaluation of the Efficacy and Safety of Imiquimod 5 Cream in Plaque-type Morphea A Pilot Prospective Open-label Study
Status:
WITHDRAWN
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study never started
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Localized scleroderma or morphea is a fibrotic disease imiquimod induces cytokines which inhibit fibrotic activity We propose that topical imiquimod 5 cream is efficacious and safe in treating plaque-type morphea Twenty adults will be enrolled for a pilot study A screening and baseline clinic visit will be required for each patient enrolled in the study Each visit will involve completing a medical history skin examination digital pictures histologic examination if the patient consents and an ultrasonographic score One morphea plaque will be treated with topical imiquimod 5 cream and another morphea lesion with vehicle cream Patients will be asked about side effects local and systemic Patients will be followed up in the clinic at 3 6 and 9 months of therapy and 3 months following end of treatment period month 12
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None