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Imiquimod for Preventing Keloid Recurrence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03760250
Recruitment Status : Terminated (Investigator decision)
First Posted : November 30, 2018
Results First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Information provided by (Responsible Party):
Thomas Leung M.D., Ph.D., University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Keloid Drug: Imiquimod 5% cream Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Open-label, Single-arm Pilot Study of the Effects of Topical 5% Imiquimod Cream on Preventing Keloid Recurrence After Surgical Keloidectomy
Actual Study Start Date : February 5, 2019
Actual Primary Completion Date : September 5, 2019
Actual Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Arm Intervention/treatment
Experimental: Imiquimod
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
Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision
Other Name: Aldara

Primary Outcome Measures :
  1. Keloid Recurrence [ Time Frame: 12 weeks after surgical excision ]
    To assess the efficacy of 5% Imiquimod cream on decreasing keloid recurrence after excision when initiated prior to excision

Secondary Outcome Measures :
  1. Tolerability - Local Site Reaction Rated on a Scale [ Time Frame: 12 weeks after surgical excision ]
    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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03760250

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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by Thomas Leung M.D., Ph.D., University of Pennsylvania:
Informed Consent Form  [PDF] March 18, 2019

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Responsible Party: Thomas Leung M.D., Ph.D., Assistant Professor of Dermatology, University of Pennsylvania Identifier: NCT03760250    
Other Study ID Numbers: 831625
First Posted: November 30, 2018    Key Record Dates
Results First Posted: November 19, 2020
Last Update Posted: November 19, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes
Collagen Diseases
Connective Tissue Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers