- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00230373
Imiquimod 5% Cream in Plaque-type Morphea: A Pilot, Prospective Open-label Study
April 22, 2015 updated by: University of Alberta
Evaluation of the Efficacy and Safety of Imiquimod 5% Cream in Plaque-type Morphea: A Pilot, Prospective Open-label Study
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).
Study Overview
Study Type
Interventional
Phase
- Phase 3
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
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Alberta
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Edmonton, Alberta, Canada, T6G 2G3
- University of Alberta
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Edmonton, Alberta, Canada, T6G 2C8
- Dr. Marlene Dytoc's clinic
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Red Deer, Alberta, Canada, T4N 6R2
- Dr. Loretta Fiorillo's clinic
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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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults and children > 6 years with plaque-type morphea
- Subject has not participated in previous study involving imiquimod for three months
- In the investigator's judgement, imiquimod treatment may benefit the patient over conventional treatment
- Subject has provided informed written consent
- Female subjects of childbearing potential have a pregnancy urine test that is negative prior to treatment
- Sexually active subjects agree to practice effective birth control throughout the duration of the study
Exclusion Criteria:
- Patients with a non-morphea skin disorder in the region of interest
- Subjects previously undergoing morphea therapy within four weeks of the study
- Subjects have a known hypersensitivity to imiquimod or component of the cream preparation
- Subjects who are pregnant or nursing
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The main outcome of this study is to evaluate the efficacy of imiquimod cream in improving morphea plaques. Improvement of skin induration will be measured by percent improvement in the skin induration as assessed radiologically by ultrasonography score.
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Secondary Outcome Measures
Outcome Measure |
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Any adverse outcome is recorded.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marlene T Dytoc, MD PhD, University of Alberta
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, 2005
Study Completion (Anticipated)
June 1, 2007
Study Registration Dates
First Submitted
September 28, 2005
First Submitted That Met QC Criteria
September 28, 2005
First Posted (Estimate)
September 30, 2005
Study Record Updates
Last Update Posted (Estimate)
April 23, 2015
Last Update Submitted That Met QC Criteria
April 22, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04CA05-IMIQ
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.
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