Imiquimod 5% Cream in Plaque-type Morphea: A Pilot, Prospective Open-label Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00230373
Recruitment Status : Withdrawn (Study never started.)
First Posted : September 30, 2005
Last Update Posted : April 23, 2015
Information provided by:
University of Alberta

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).

Condition or disease Intervention/treatment Phase
Morphea Drug: imiquimod 5% cream (Aldara) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Imiquimod 5% Cream in Plaque-type Morphea: A Pilot, Prospective Open-label Study
Study Start Date : November 2005
Estimated Study Completion Date : June 2007

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Any adverse outcome is recorded.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00230373

Canada, Alberta
Dr. Marlene Dytoc's clinic
Edmonton, Alberta, Canada, T6G 2C8
University of Alberta
Edmonton, Alberta, Canada, T6G 2G3
Dr. Loretta Fiorillo's clinic
Red Deer, Alberta, Canada, T4N 6R2
Sponsors and Collaborators
University of Alberta
Principal Investigator: Marlene T Dytoc, MD PhD University of Alberta Identifier: NCT00230373     History of Changes
Other Study ID Numbers: 04CA05-IMIQ
First Posted: September 30, 2005    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: April 2015

Keywords provided by University of Alberta:
Localized scleroderma

Additional relevant MeSH terms:
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers