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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Keloid Device: The Lutronic electronic carbon dioxide (eCO2) Plus laser system Drug: Intralesional Triamcinolone Acetonide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fractional Laser Assisted Steroid Therapy vs Intralesional Steroids in the Treatment of Keloids
Actual Study Start Date : April 2016
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : June 15, 2018


Arm Intervention/treatment
Experimental: 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 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
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

Drug: Intralesional Triamcinolone Acetonide
Active Comparator: Intralesional triamcinolone acetonide alone
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



Primary Outcome Measures :
  1. Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: 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.

  2. Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996097


Locations
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United States, Maryland
Johns Hopkins School of Medicine, Department of Dermatology
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Ginette Okoye, MD Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
Study Protocol  [PDF] May 27, 2016
Statistical Analysis Plan  [PDF] May 27, 2016


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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02996097    
Other Study ID Numbers: IRB00082453
First Posted: December 19, 2016    Key Record Dates
Results First Posted: April 25, 2019
Last Update Posted: April 25, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Anesthetics
Anesthetics, Local
Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Lidocaine
Tetracaine
Triamcinolone diacetate
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors