Status:
TERMINATED
Imiquimod for Preventing Keloid Recurrence
Lead Sponsor:
University of Pennsylvania
Conditions:
Keloid
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ge...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03760250
Start Date
February 5 2019
End Date
September 1 2020
Last Update
November 19 2020
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104