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

Primary Purpose

Keloid

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Lutronic electronic carbon dioxide (eCO2) Plus laser system
Intralesional Triamcinolone Acetonide
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins School of Medicine, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CO2 ablative laser plus intralesional triamcinolone acetonide

Intralesional triamcinolone acetonide alone

Arm 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 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

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2016
Last Updated
December 14, 2020
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02996097
Brief Title
Fractional Laser Assisted Steroid Therapy vs Intralesional Steroids in the Treatment of Keloids
Official Title
Fractional Laser Assisted Steroid Therapy vs Intralesional Steroids in the Treatment of Keloids
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
June 15, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CO2 ablative laser plus intralesional triamcinolone acetonide
Arm Type
Experimental
Arm 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 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
Arm Title
Intralesional triamcinolone acetonide alone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
The Lutronic electronic carbon dioxide (eCO2) Plus laser system
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Intralesional Triamcinolone Acetonide
Primary Outcome Measure Information:
Title
Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS)
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
Title
Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ginette Okoye, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Medicine, Department of Dermatology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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

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