Imiquimod for Preventing Keloid Recurrence
Condition: Keloid
MeSH terms: Keloid; Recurrence
Intervention: Imiquimod 5% cream
Intervention description: Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision
Intervention MeSH terms: Imiquimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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