Imiquimod for Preventing Keloid Recurrence



Status:Recruiting
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:2/14/2019
Start Date:February 5, 2019
End Date:January 1, 2020

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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. 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.


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
We found this trial at
1
site
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-662-2737
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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