Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-31 @ 10:44 PM
Study NCT ID:
NCT03760250
Status:
TERMINATED
Last Update Posted:
2020-11-19
First Post:
2018-11-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Imiquimod for Preventing Keloid Recurrence
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Open-label, Single-arm Pilot Study of the Effects of Topical 5% Imiquimod Cream on Preventing Keloid Recurrence After Surgical Keloidectomy
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label, single-arm, pilot study on the effects of topical imiquimod treatment in preventing keloid recurrence after surgical excision. Keloids are abnormal scars that form in certain genetically predisposed individuals following trauma to the skin. They can be physically disabling and cause social impairment. Many therapies have been proposed and trialed for the permanent removal of keloids, but they all have limited efficacy. Topical imiquimod therapy has been reported to decrease keloid recurrence following keloidectomy in human patients. Given all previous reports of adjuvant imiquimod therapy to keloidectomy initiated imiquimod therapy after keloidectomy, the investigators would like to test the efficacy of topical imiquimod pre-treatment in preventing keloid recurrence after surgical excision. Therefore, the investigators are initiating an open-label pilot study of 10 patients age 18 or greater with keloids on the trunk and extremities excluding the groin and hands and feet who present to the dermatology clinic for standard of care keloid excision. Key exclusion criteria include vulnerable populations, immunocompromised state, hypersensitivity to study drug components, and keloids outside of specified areas. The main study intervention will be 6 weeks of treatment with topical 5% imiquimod cream, starting 1 week prior to surgical excision.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: