- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03760250
Imiquimod for Preventing Keloid Recurrence
November 16, 2020 updated by: Thomas Leung M.D., Ph.D., University of Pennsylvania
Open-label, Single-arm Pilot Study of the Effects of Topical 5% Imiquimod Cream on Preventing Keloid Recurrence After Surgical Keloidectomy
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks after surgical excision
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
12 weeks after surgical excision
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2019
Primary Completion (Actual)
September 5, 2019
Study Completion (Actual)
September 1, 2020
Study Registration Dates
First Submitted
November 28, 2018
First Submitted That Met QC Criteria
November 28, 2018
First Posted (Actual)
November 30, 2018
Study Record Updates
Last Update Posted (Actual)
November 19, 2020
Last Update Submitted That Met QC Criteria
November 16, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 831625
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Keloid
-
CHA UniversityCompletedHypertrophic or Keloid ScarsKorea, Republic of
-
NYU Langone HealthCompleted
-
Northwestern UniversityCompleted
-
Queen Mary University of LondonWithdrawn
-
SolitonEmergent Clinical Consulting, LLCCompleted
-
Sensus HealthcareUnknownKeloid ScarUnited States
-
Sensus HealthcareUnknown
-
University of UlmCompleted
-
Next Science TMJacksonville Center For Clinical ResearchWithdrawnKeloid Scar Following SurgeryUnited States
-
Our Lady of the Lake HospitalLouisiana State University Health Sciences Center in New OrleansCompletedPost-Surgical Injection With Triamcinolone Versus Triamcinolone/Fluorouracil in Treatment of KeloidsKeloid | Keloid Scar Following SurgeryUnited States
Clinical Trials on Imiquimod 5% cream
-
Graceway Pharmaceuticals, LLCCompletedActinic KeratosisUnited States
-
Graceway Pharmaceuticals, LLCCompletedSuperficial Basal Cell CarcinomaAustralia, New Zealand
-
Graceway Pharmaceuticals, LLCCompletedKeratosisUnited States
-
Graceway Pharmaceuticals, LLCCompletedGenital WartsUnited States
-
St. Justine's HospitalGraceway Pharmaceuticals, LLCCompletedHemangioma, CapillaryCanada
-
Medical University of ViennaTerminatedActinic KeratosesAustria
-
Medical University InnsbruckNot yet recruitingAnogenital Human Papillomavirus Infection | Condyloma AnalAustria
-
Graceway Pharmaceuticals, LLCCompletedGenital WartsUnited States
-
VA Office of Research and DevelopmentNot yet recruiting