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

Morphea Clinical Trial

Official title:

Evaluation of the Efficacy and Safety of Imiquimod 5% Cream in Plaque-type Morphea: A Pilot, Prospective Open-label Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00230373
• Other study ID #: 04CA05-IMIQ
• Status: Withdrawn
• Phase: Phase 3
• First received: September 28, 2005
• Last updated: April 22, 2015
• Start date: November 2005
• Est. completion date: June 2007

Study information

• Verified date: April 2015
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morphea
• Scleroderma, Localized

Intervention

Drug:
• imiquimod 5% cream (Aldara)

Locations

Country	Name	City	State
Canada	Dr. Marlene Dytoc's clinic	Edmonton	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Dr. Loretta Fiorillo's clinic	Red Deer	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	3M

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Any adverse outcome is recorded.