Scleroderma, LocalizedPhase 3NCT00147771
Imiquimod in Children With Plaque Morphea
A Phase 3 study testing Imiquimod 5% cream in people with Scleroderma, Localized, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Morphea is very hard to treat. In a small number of adult patients, Imiquimod has proven to be beneficial in decreasing the thickness of the morphea plaques , while improving their appearance. There are no studies to date proving its safety and efficacy in children with this disease. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Scleroderma, Localized
- What is being tested?
- Imiquimod 5% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Sep 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age at diagnosis 6 to 18 years of age
- Morphea plaques
- Female subjects of childbearing potential must have a negative urine pregnancy test
- Signed consent/assent form
Who cannot join
- Children who received topical corticosteroids, tacrolimus, vitamin D derivatives (calcipotriol, calcipotriol-betamethasone dipropionate) to the affected area in the previous four weeks
- Children who were previously treated with Imiquimod on the affected areas
- Children with no demonstrable ultrasonographic changes at the baseline evaluation
- Children with evidence of skin breakdown on the proposed area to be treated at the time of enrollment due to potential increased absorption of the medication through impaired skin barrier
- Female subjects of childbearing potential who do not agree to practice effective birth control methods for the duration of the study
- Children who are/were (in the past 6 months) treated with systemic medications such as methotrexate and/or systemic corticosteroids
- Co-morbidities: systemic sclerosis, juvenile rheumatoid arthritis, other systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of the Imiquimod 5% Topical Cream in Plaque Morphea: A Prospective, Multiple Baseline, Open Label Pilot Study
Morphea is very hard to treat. In a small number of adult patients, Imiquimod has proven to be beneficial in decreasing the thickness of the morphea plaques , while improving their appearance. There are no studies to date proving its safety and efficacy in children with this disease. We propose to conduct a pilot study to assess to potential efficacy and relative safety of Imiquimod in children with plaque morphea.
Read the detailed description
Design: Prospective, open label, pilot study
Settings: The Hospital for Sick Children, Specialized Morphea Clinic
Study population:
- Children 6-18 years of age
- Plaque morphea measuring less than 10 cm2 in diameter ( for children with multiple lesions, only one will be treated)
Intervention: Topical imiquimod applied 3-5 times a week for 6 months
Outcome measures: Decrease in the thickness of the skin by clinical scores and ultrasonography
Duration of the study: 12 months ( 2 baseline visits, 1 intervention visit, 5 follow-up visits)
- Conditions
- Scleroderma, Localized
- Being tested
- Imiquimod 5% cream
- Keywords
- localized scleroderma, morphea, imiquimod, pediatrics
- Medical subject headings
- Scleroderma, Localized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imiquimod 5% creamDrug
Treatment will last for 36 weeks. Patients will be instructed to apply Imiquimod three times per week for 4 weeks. If no local side effects are noted at the 4 week- follow-up visit, the frequency of the application will be increased to 5 weekly applications.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Imiquimod 5% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent improvement in the thickness of the skin
Measured: 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks
Secondary outcomes (1)
Frequency of side-effects
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma, LocalizedStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Pope, The Hospital for Sick Children
- Investigators
- Elena Pope, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147771
- Sponsor's protocol ID
- 1000007595
- Status last verified
- Aug 2013
- First submitted
- 2 Sep 2005
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of the Imiquimod 5% Topical Cream in Plaque Morphea: A Prospective, Multiple Baseline, Open Label Pilot Study
- ClinicalTrials.gov ID
- NCT00147771
- Acronym / sponsor ID
- 1000007595
- Conditions
- Scleroderma, Localized
- Keywords
- localized scleroderma, morphea, imiquimod, pediatrics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Morphea is very hard to treat. In a small number of adult patients, Imiquimod has proven to be beneficial in decreasing the thickness of the morphea plaques , while improving their appearance. There are no studies to date proving its safety and efficacy in children with this disease. We propose to conduct a pilot study to assess to potential efficacy and relative safety of Imiquimod in children with plaque morphea.
Detailed description
Design: Prospective, open label, pilot study
Settings: The Hospital for Sick Children, Specialized Morphea Clinic
Study population:
- Children 6-18 years of age
- Plaque morphea measuring less than 10 cm2 in diameter ( for children with multiple lesions, only one will be treated)
Intervention: Topical imiquimod applied 3-5 times a week for 6 months
Outcome measures: Decrease in the thickness of the skin by clinical scores and ultrasonography
Duration of the study: 12 months ( 2 baseline visits, 1 intervention visit, 5 follow-up visits)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Imiquimod 5% cream |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age at diagnosis 6 to 18 years of age
- Morphea plaques
- Female subjects of childbearing potential must have a negative urine pregnancy test
- Signed consent/assent form
Key exclusion criteria (7 listed)
- Children who received topical corticosteroids, tacrolimus, vitamin D derivatives (calcipotriol, calcipotriol-betamethasone dipropionate) to the affected area in the previous four weeks
- Children who were previously treated with Imiquimod on the affected areas
- Children with no demonstrable ultrasonographic changes at the baseline evaluation
- Children with evidence of skin breakdown on the proposed area to be treated at the time of enrollment due to potential increased absorption of the medication through impaired skin barrier
- Female subjects of childbearing potential who do not agree to practice effective birth control methods for the duration of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imiquimod 5% creamTreatment will last for 36 weeks. Patients will be instructed to apply Imiquimod three times per week for 4 weeks. If no local side effects are noted at the 4 week- follow-up visit, the frequency of the application will be increased to 5 weekly applications. | Drug | 1 |
Primary outcome
Percent improvement in the thickness of the skin
Time frame: 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks
1 secondary outcome
Frequency of side-effects
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
Related trials for Scleroderma, Localized
Active, not recruitingObservational study
Cross-cultural Adaptation and Validation of the Localised Scleroderma Quality of Life Instrument (LoSQI) in Juvenile Localised Scleroderma (JLS)
Scleroderma
Active, not recruiting
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Scleroderma, Systemic, Morphea
RecruitingObservational study
Morphea in Adults and Children (MAC) Cohort Study: A Morphea Registry and DNA Repository
Scleroderma, Localized, Morphea
Enrolling by invitationObservational study
Elastography Ultrasound in Localized Scleroderma (Morphea) Study
Scleroderma
Active, not recruiting
Brain Boost Program to Improve Cognitive Function in People With Systemic Sclerosis
Scleroderma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Pope, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imiquimod 5% cream in people with Scleroderma, Localized, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent improvement in the thickness of the skin (time frame: 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.