Trial Outcomes & Findings for Fractional Laser Assisted Steroid Therapy vs Intralesional Steroids in the Treatment of Keloids (NCT NCT02996097)

NCT ID: NCT02996097

Last Updated: 2020-12-17

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Once every 4 weeks for 16 weeks
• Results posted on: 2020-12-17

Participant Flow

Unit of analysis: lesions

Participant milestones

Measure	CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide A topical eutectic mixture of local anesthetics (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 Lutronic electronic carbon dioxide (eCO2) Plus fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide at 4 weeks intervals.	Intralesional Triamcinolone Acetonide Only A topical eutectic mixture of local anesthetics (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 intralesional triamcinolone acetonide only at 4 week intervals.
Overall Study STARTED	30 30	30 30
Overall Study Per Protocol Population	22 22	22 22
Overall Study COMPLETED	19 19	19 19
Overall Study NOT COMPLETED	11 11	11 11

Reasons for withdrawal

Measure	CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide A topical eutectic mixture of local anesthetics (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 Lutronic electronic carbon dioxide (eCO2) Plus fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide at 4 weeks intervals.	Intralesional Triamcinolone Acetonide Only A topical eutectic mixture of local anesthetics (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 intralesional triamcinolone acetonide only at 4 week intervals.
Overall Study Lost to Follow-up	11	11

Baseline Characteristics

Fractional Laser Assisted Steroid Therapy vs Intralesional Steroids in the Treatment of Keloids

Baseline characteristics by cohort

Measure	All Participants n=30 Participants All enrolled participants had two keloids on them, each keloid selected for an intervention arm of the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide n=22 lesions A topical eutectic mixture of local anesthetics (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 Lutronic electronic carbon dioxide (eCO2) Plus fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide at 4 weeks intervals.	Intralesional Triamcinolone Acetonide Only n=22 lesions A topical eutectic mixture of local anesthetics (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 intralesional triamcinolone acetonide only at 4 week intervals.
Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS)	-9.5 score on a scale Interval -12.2 to -6.0	-8.9 score on a scale Interval -11.7 to -6.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide n=22 lesions A topical eutectic mixture of local anesthetics (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 Lutronic electronic carbon dioxide (eCO2) Plus fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide at 4 weeks intervals.	Intralesional Triamcinolone Acetonide Only n=22 lesions A topical eutectic mixture of local anesthetics (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 intralesional triamcinolone acetonide only at 4 week intervals.
Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)	-22.6 score on a scale Interval -28.5 to -16.7	-18.8 score on a scale Interval -24.5 to -13.2

Adverse Events

CO2 Ablative Laser +/- Intralesional Triamcinolone Acetonide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ginette Okoye

Johns Hopkins School of Medicine

Phone: 9142158980

Email: ginette.okoye@howard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place