Imiquimod for Preventing Keloid Recurrence

University of Pennsylvania

Status and phase: Terminated; Phase 2

Conditions: Keloid

Treatments: Drug: Imiquimod 5% cream

Study type: Interventional

Funder types: Other

Identifiers

NCT03760250

831625

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Imiquimod

Experimental group

Description:

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

Treatment:

Drug: Imiquimod 5% cream