Keloid
Conditions
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.
Interventions
Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Keloid Recurrence | 12 weeks after surgical excision | To assess the efficacy of 5% Imiquimod cream on decreasing keloid recurrence after excision when initiated prior to excision |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability - Local Site Reaction Rated on a Scale | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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: Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Imiquimod |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Keloid Recurrence
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imiquimod | Keloid Recurrence | Recurred | 3 Participants |
| Imiquimod | Keloid Recurrence | Did not recur | 1 Participants |
Secondary
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)
Time frame: 12 weeks after surgical excision
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imiquimod | Tolerability - Local Site Reaction Rated on a Scale | local site reaction: none | 0 Participants |
| Imiquimod | Tolerability - Local Site Reaction Rated on a Scale | local site reaction: mild | 4 Participants |
| Imiquimod | Tolerability - Local Site Reaction Rated on a Scale | local site reaction: moderate | 0 Participants |
| Imiquimod | Tolerability - Local Site Reaction Rated on a Scale | local site reaction: severe | 0 Participants |