Fractional Laser Assisted Steroid Therapy vs Intralesiona... | NCT02996097

NCT02996097

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CO2 ablative laser plus intralesional triamcinolone acetonide	Experimental	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 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	Device: The Lutronic electronic carbon dioxide (eCO2) Plus laser system Drug: Intralesional Triamcinolone Acetonide
Intralesional triamcinolone acetonide alone	Active Comparator	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. The other chosen lesion would be treated with intralesional triamcinolone acetonide alone at 4 week intervals.	Drug: Intralesional Triamcinolone Acetonide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The Lutronic electronic carbon dioxide (eCO2) Plus laser system	Device	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Once every 4 weeks for 16 weeks
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.	Once every 4 weeks for 16 weeks

Eligibility Module

Eligibility Criteria

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 exclusion criteria at the screening visit and/or at the baseline visit will not be included in this study:

The subject has an underlying known disease, a surgical or medical condition that in the opinion of the investigator might put the subject at risk
The subject is pregnant or breastfeeding at the time of enrollment or is planning to become pregnant at any point during the study period
The subject has a past history of coagulopathy
The subject has an underlying dermatological disease that in the opinion of the investigator could interfere with the study evaluations
The subject has used prohibited topical or systemic treatments without sufficient protocol-defined wash-out period prior to Baseline (checked at Screening and Baseline) or is unwilling to refrain from use during the study
The subject is treated with anticoagulants or antiplatelet therapies
The subject has a known allergy or sensitivity to any local anesthetic drug (e.g. EMLA or tetracaine 7%/lidocaine 23%) or a local antiseptic planned to be used for the laser.
The subject is in an exclusion period from a previous study or is participating in another clinical trial
The subject is an adult under guardianship or is hospitalized in a public or private institution, or is deprived of freedom
The subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function

Name	Affiliation	Role
Ginette Okoye, MD	Johns Hopkins University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins School of Medicine, Department of Dermatology		Baltimore	Maryland	21287	United States

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	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.

Baseline Characteristics Module

ID	Title	Description
BG000	All Participants	All enrolled participants had two keloids on them, each keloid selected for an intervention arm of the study.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

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.

Posted

Mean

95% Confidence Interval

score on a scale

Once every 4 weeks for 16 weeks

lesions

ID	Title	Description
OG000	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CO2 Ablative Laser +/- Intralesional Triamcinolone Acetonide	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 27, 2016	Mar 28, 2019	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	May 27, 2016	Mar 28, 2019	SAP_001.pdf

ID	Term
D003095	Collagen Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D002921	Cicatrix