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

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ClinicalTrials.gov Identifier: NCT02996097
Recruitment Status : Completed
First Posted : December 19, 2016
Results First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Keloid
Interventions Device: The Lutronic electronic carbon dioxide (eCO2) Plus laser system
Drug: Intralesional Triamcinolone Acetonide
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide Intralesional Triamcinolone Acetonide Only
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Number of participants Number of units (lesions) Number of participants Number of units (lesions)
Started 30 30 30 30
Per Protocol Population 22 22 22 22
Completed 19 19 19 19
Not Completed 11 11 11 11
Reason Not Completed
Lost to Follow-up             11                         11            
Arm/Group Title All Participants
Hide Arm/Group Description All enrolled participants had two keloids on them, each keloid selected for an intervention arm of the study.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
29
  96.7%
>=65 years
1
   3.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
15
  50.0%
Male
15
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
  13.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
21
  70.0%
White
3
  10.0%
More than one race
0
   0.0%
Unknown or Not Reported
2
   6.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
 100.0%
1.Primary Outcome
Title Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide Intralesional Triamcinolone Acetonide Only
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 22 22
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
22 22
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-9.5
(-12.2 to -6)
-8.9
(-11.7 to -6)
2.Primary Outcome
Title Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide Intralesional Triamcinolone Acetonide Only
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 22 22
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
22 22
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-22.6
(-28.5 to -16.7)
-18.8
(-24.5 to -13.2)
Time Frame 14 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CO2 Ablative Laser +/- Intralesional Triamcinolone Acetonide
Hide Arm/Group Description 2 keloids on each patient will be selected as treatment sites. 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. The other keloid will be treated with intralesional triamcinolone acetonide only at 4 week intervals.
All-Cause Mortality
CO2 Ablative Laser +/- Intralesional Triamcinolone Acetonide
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
CO2 Ablative Laser +/- Intralesional Triamcinolone Acetonide
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CO2 Ablative Laser +/- Intralesional Triamcinolone Acetonide
Affected / at Risk (%)
Total   0/30 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ginette Okoye
Organization: Johns Hopkins School of Medicine
Phone: 9142158980
EMail: ginette.okoye@howard.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02996097     History of Changes
Other Study ID Numbers: IRB00082453
First Submitted: December 14, 2016
First Posted: December 19, 2016
Results First Submitted: April 1, 2019
Results First Posted: April 25, 2019
Last Update Posted: April 25, 2019