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Imiquimod for Preventing Keloid Recurrence

Primary Purpose

Keloid

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Imiquimod 5% cream
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Keloid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imiquimod

Arm Description

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

Outcomes

Primary Outcome Measures

Keloid Recurrence
To assess the efficacy of 5% Imiquimod cream on decreasing keloid recurrence after excision when initiated prior to excision

Secondary Outcome Measures

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)

Full Information

First Posted
November 28, 2018
Last Updated
November 16, 2020
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03760250
Brief Title
Imiquimod for Preventing Keloid Recurrence
Official Title
Open-label, Single-arm Pilot Study of the Effects of Topical 5% Imiquimod Cream on Preventing Keloid Recurrence After Surgical Keloidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Investigator decision
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imiquimod
Arm Type
Experimental
Arm Description
5% Imiquimod cream once daily to keloid area 5-times a week for 6 weeks, starting 1-week prior to keloid excision
Intervention Type
Drug
Intervention Name(s)
Imiquimod 5% cream
Other Intervention Name(s)
Aldara
Intervention Description
Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision
Primary Outcome Measure Information:
Title
Keloid Recurrence
Description
To assess the efficacy of 5% Imiquimod cream on decreasing keloid recurrence after excision when initiated prior to excision
Time Frame
12 weeks after surgical excision
Secondary Outcome Measure Information:
Title
Tolerability - Local Site Reaction Rated on a Scale
Description
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)
Time Frame
12 weeks after surgical excision

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Imiquimod for Preventing Keloid Recurrence

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