Clinical trial NCT03760250: Imiquimod for Preventing Keloid Recurrence
Official title: Open-label, Single-arm Pilot Study of the Effects of Topical 5% Imiquimod Cream on Preventing Keloid Recurrence After Surgical Keloidectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Keloid
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Keloid Recurrence
timeFrame: 12 weeks after surgical excision
Secondary outcomes:
measure: Tolerability - Local Site Reaction Rated on a Scale
timeFrame: 12 weeks after surgical excision
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: