Imiquimod for Preventing Keloid Recurrence

Phase 2

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

Age 18 or greater
Men and women who present clinically with keloids requesting excision
Any number of keloids
Keloid no larger than 5cm in diameter at the base
Clinical findings consistent with keloid formation
Location of keloid in low-risk areas - areas other than above the neck, hands, feet, or groin
Able and willing to give informed consent

Exclusion Criteria

Age < 18
Hypersensitivity to Imiquimod or to any of the excipients (methylhydroxybenzoate, propylhydroxybenzoate, cetyl alcohol, and stearyl alcohol)
Involvement in a trial of another experimental intervention within 30 days
Life threatening disease
Use of immunosuppressive medications such as oral corticosteroids
Bleeding disorders
Not available for follow-up for 10 weeks
Pregnant, intention to become pregnant during treatment phase of trial, or breastfeeding

Arm && Interventions

Group	Intervention	Description
Imiquimod	Imiquimod 5% cream	5% Imiquimod cream once daily to keloid area 5-times a week for 6 weeks, starting 1-week prior to keloid excision

Primary Outcome Measures

Name	Time	Method
Keloid Recurrence	12 weeks after surgical excision	To assess the efficacy of 5% Imiquimod cream on decreasing keloid recurrence after excision when initiated prior to excision

Secondary Outcome Measures

Name	Time	Method
Tolerability - Local Site Reaction Rated on a Scale	12 weeks after surgical excision	tolerability of 5% imiquimod cream - clinical evaluation of local site reactions by clinicians for symptoms such as redness, discomfort, swelling, and ulceration at the site of drug application on the following scale with none being the best and severe the worst: none (no reaction in application site), mild (slight redness in application site), moderate (redness with swelling and pain in application site), severe (redness, swelling, ulceration in application site)

Locations (1): University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial