Imiquimod for Preventing Keloid Recurrence

Keloid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03760250
• Other study ID #: 831625
• Status: Terminated
• Phase: Phase 2
• Start date: February 5, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: November 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 1, 2020
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Keloid
• Recurrence

Intervention

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

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Keloid Recurrence	To assess the efficacy of 5% Imiquimod cream on decreasing keloid recurrence after excision when initiated prior to excision	12 weeks after surgical excision
Secondary	Tolerability - Local Site Reaction Rated on a Scale	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)	12 weeks after surgical excision