Keloid
Conditions
Brief summary
The purpose of this study is to compare the effects of fractional carbon dioxide (CO2) laser therapy immediately followed by intralesional steroid therapy against intralesional steroid therapy alone for the treatment of keloids.
Detailed description
Intralesional corticosteroids remain the gold standard treatment for keloids. However, more effective therapies are desperately desired. Ablative fractional laser (AFL) treatment facilitates delivery of intralesional steroid more deeply and uniformly into the skin by creating vertical channels. Recent studies have showed that fractional laser assisted steroid therapy can be effective in the treatment of keloids. However the studies are lacking in comparing this treatment modality to the gold standard of intralesional steroids.
Interventions
DEVICEThe Lutronic electronic carbon dioxide (eCO2) Plus laser system
CO2 ablative laser plus intralesional triamcinolone acetonide A topical EMLA cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide. One lesion would be treated with fractional CO2 ablative laser followed with intralesional triamcinolone acetonide at 4 weeks intervals
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female older than 17 at the screening visit; * The subject is healthy, as determined by the investigator based on a medical evaluation including medical history; * The subject has at least two keloids of comparative size and texture located on the same general anatomic location (trunk or back); * The subject is willing and able to comply with the requirements of the protocol. In particular, subject must adhere to the visits schedule and concomitant therapy. The subject is willing to comply with the 4 week washout period; * The subject has understood and signed an Informed Consent Form approved by the Institutional Review Board (IRB) prior to any investigational procedure
Exclusion criteria
Any subject who is meeting one or more of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS) | Once every 4 weeks for 16 weeks | Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score. |
| Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS) | Once every 4 weeks for 16 weeks | Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All enrolled participants had two keloids on them, each keloid selected for an intervention arm of the study. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 11 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 21 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 | 2 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS)
Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.
Time frame: Once every 4 weeks for 16 weeks
Population: Analyzed 19 participants who completed the study (5 visits) in addition to the 3 participants who completed 3 of 5 visits to provide enough data for this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide | Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS) | -9.5 score on a scale |
| Intralesional Triamcinolone Acetonide Only | Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS) | -8.9 score on a scale |
Primary
Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)
Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.
Time frame: Once every 4 weeks for 16 weeks
Population: Analyzed 19 participants who completed the study (5 visits) in addition to the 3 participants who completed 3 of 5 visits to provide enough data for this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide | Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS) | -22.6 score on a scale |
| Intralesional Triamcinolone Acetonide Only | Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS) | -18.8 score on a scale |