NCT03760250

Imiquimod for Preventing Keloid Recurrence

Open-label, Single-arm Pilot Study of the Effects of Topical 5% Imiquimod Cream on Preventing Keloid Recurrence After Surgical Keloidectomy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Keloid

Interventions

Type	Name	Description
DRUG	Imiquimod 5% cream	Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision

Timeline

• Start date: 2019-02-05
• Primary completion: 2019-09-05
• Completion: 2020-09-01
• First posted: 2018-11-30
• Last updated: 2020-11-19
• Results posted: 2020-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study