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

NCT00230373 | Withdrawn Phase 3 DMC

• 1 other identifier: 04CA05-IMIQ
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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).

Conditions

Morphea

Keywords

Localized scleroderma

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• Any adverse outcome is recorded.

Interventions

imiquimod 5% cream (Aldara) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• 3M: collaborator

Study Sites (3)

Dr. Marlene Dytoc's clinic

Edmonton, Alberta, T6G 2C8, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

Location

Dr. Loretta Fiorillo's clinic

Red Deer, Alberta, T4N 6R2, Canada

Location

MeSH Terms

Conditions

Scleroderma, Localized

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Marlene T Dytoc, MD PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 28, 2005
• First Posted: September 30, 2005
• Study Start: November 1, 2005
• Study Completion: June 1, 2007
• Last Updated: April 23, 2015

Record last verified: 2015-04

Locations

CA (3)