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Imiquimod for Preventing Keloid Recurrence

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ClinicalTrials.gov Identifier: NCT03760250
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : February 12, 2019
Sponsor:
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. In the laboratory, the investigators observed that topical imiquimod pre-treatment (imiquimod initiated prior to onset of trauma) improves wound closure and decreases scar formation in mouse ear-punch models of wound healing. 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)
Estimated Enrollment : 10 participants
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
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 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 on the following scale: none, mild (slight redness), moderate (redness with swelling and pain), severe (redness, swelling, ulceration)



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

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 ClinicalTrials.gov identifier (NCT number): NCT03760250


Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jenny Wei    215-662-2737    jenny.wei@pennmedicine.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania

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Responsible Party: Thomas Leung M.D., Ph.D., Assistant Professor of Dermatology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03760250     History of Changes
Other Study ID Numbers: 831625
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

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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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Recurrence
Keloid
Disease Attributes
Pathologic Processes
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers