Imiquimod for Preventing Keloid Recurrence

NCT ID: NCT03760250

Last Updated: 2020-11-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-05
• Study Completion Date: 2020-09-01

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.

Conditions

Keloid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Imiquimod

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

Group Type: EXPERIMENTAL

Imiquimod 5% cream

Intervention Type: DRUG

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

Interventions

Imiquimod 5% cream

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

Intervention Type: DRUG

Other Intervention Names

Aldara

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Thomas Leung M.D., Ph.D.

Assistant Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

831625

Identifier Type: -

Identifier Source: org_study_id