Imiquimod for Preventing Keloid Recurrence

NCT03760250 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 831625
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Tolerability - Local Site Reaction Rated on a Scale

  12 weeks after surgical excision

Study Arms (1)

Imiquimod

EXPERIMENTAL

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

Drug: Imiquimod 5% cream

Interventions

Imiquimod 5% cream DRUG

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

Also known as: Aldara

Imiquimod

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Keloid

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jenny Wei
• Organization: University of Pennsylvania

jenny.wei@pennmedicine.upenn.edu

2153165151

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: November 30, 2018
• Study Start: February 5, 2019
• Primary Completion: September 5, 2019
• Study Completion: September 1, 2020
• Last Updated: November 19, 2020
• Results First Posted: November 19, 2020

Record last verified: 2020-11

Locations

US (1)