Keloid
Conditions
Brief summary
1. To test whether topical rapamycin regresses established keloids in humans by measuring surface area and height changes in the scar over time (6 months) 2. To test safety of product and feasibility of conduct for future clinical trial
Detailed description
This pilot trial will use daily 0.5-1.0 ml applications of 8% RAPA (Rapamycin) in a petrolatum vehicle to treat established keloid lesions in 5 persons with at least 2 chronic keloids in similar body regions (greater than 1-year duration). Treatment will be applied once daily for 6 months. One keloid will receive 8% RAPA ointment and the other keloid will receive petrolatum-only ointment as a control. Surface areas and height of keloids will be monitored pre- and post-treatment to evaluate responses. Keloid surface area and height changes will be measured pre-treatment and thereafter on a monthly basis using standardized digital photography with a tripod-mounted 8MP Canon S5is camera and calipers to measure keloid height (37). Surface areas of all photographed lesions will be measured with Image J (http://rsbweb.nih.gov/ij/index.html), a public image-processing program that was used to analyze preliminary data and this study will use the same approach.
Interventions
DRUGPlacebo
Petrolatum ointment placebo
DRUGRapamycin 8% Ointment
A compounded ointment containing 8% rapamycin
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Study participants will serve as their own control, using intervention on one keloid and placebo on the other
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject must have at least 2 keloid scars (for at least 1 year) in similar body locations that are easy to reach to apply ointment to * Subject will be in good health with all chronic diseases (such as hypertension, coronary artery disease, etc.) clinically stable * Cognitive functioning sufficient to provide informed consent * Physically able to apply ointment to keloids daily * Able to attend monthly clinic visits for 6 months
Exclusion criteria
* Diagnosis of diabetes * Subjects taking the following medications: systemic steroid or immunosuppressant therapy within the past 6 months * Local area steroidal treatment within the past 3 months * History of allergy to rapamycin of petrolatum-based products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Keloid Surface Area | Baseline to 6 months | Measurement of surface area of keloid |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Keloid Height | Baseline to 6 months | Measurement of height of keloid |
Countries
United States
Participant flow
Recruitment details
Each subject enrolled was used as both active intervention and placebo, using 2 keloids on the same subject, color coded to have either rapamycin ointment or placebo ointment applied.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Participants Rapamycin ointment will be applied to one keloid on the subject and placebo will be applied to a second keloid.
Keloids will be color coded to match ointment applied
Rapamycin 8% Ointment: A compounded ointment containing 8% rapamycin Placebo: Petrolatum ointment | 3 |
| Overall Study Participants Rapamycin ointment will be applied to one keloid on the subject and placebo will be applied to a second keloid.
Keloids will be color coded to match ointment applied
Rapamycin 8% Ointment: A compounded ointment containing 8% rapamycin Placebo: Petrolatum ointment | 3 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Overall Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 1 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
Primary
Change in Keloid Surface Area
Measurement of surface area of keloid
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| RAPA Intervention | Change in Keloid Surface Area | 0.455 cm2 |
| Placebo | Change in Keloid Surface Area | -0.039 cm2 |
Secondary
Change in Keloid Height
Measurement of height of keloid
Time frame: Baseline to 6 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| RAPA Intervention | Change in Keloid Height | Baseline | 1.5 millimeters |
| RAPA Intervention | Change in Keloid Height | 6 months | 1.056 millimeters |
| Placebo | Change in Keloid Height | Baseline | 1.55 millimeters |
| Placebo | Change in Keloid Height | 6 months | 0.93 millimeters |