Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147771
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2005-09-02
Brief Title:
Imiquimod in Children With Plaque Morphea
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None