Imiquimod 5% Cream in Plaque-Type Morphea: A Pilot, Prospective Open-Label Study

This study has been withdrawn prior to enrollment.
(Study never started.)
Sponsor:
Collaborator:
3M
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00230373
First received: September 28, 2005
Last updated: June 17, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Morphea
Drug: imiquimod 5% cream (Aldara)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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:
  • Any adverse outcome is recorded.

Estimated Enrollment: 20
Study Start Date: November 2005
Estimated Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230373

Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2G3
Dr. Marlene Dytoc's clinic
Edmonton, Alberta, Canada, T6G 2C8
Dr. Loretta Fiorillo's clinic
Red Deer, Alberta, Canada, T4N 6R2
Sponsors and Collaborators
University of Alberta
3M
Investigators
Principal Investigator: Marlene T Dytoc, MD PhD University of Alberta
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00230373     History of Changes
Other Study ID Numbers: 04CA05-IMIQ
Study First Received: September 28, 2005
Last Updated: June 17, 2008
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Localized scleroderma

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

ClinicalTrials.gov processed this record on August 28, 2014