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Carboxytherapy in the Treatment of Atrophic Scars

Primary Purpose

Atrophic Scar

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carboxytherapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophic Scar

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: traumatic and surgical scar Exclusion Criteria: active infections

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Carboxytherapy

    Fractional CO2 laser

    Platelet rich plasma

    Arm Description

    Device

    Device

    platelet rich plasma

    Outcomes

    Primary Outcome Measures

    Modified Vancouver score

    Secondary Outcome Measures

    Full Information

    First Posted
    January 13, 2023
    Last Updated
    January 13, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05695807
    Brief Title
    Carboxytherapy in the Treatment of Atrophic Scars
    Official Title
    Efficacy of Carboxy Therapy Versus Fractional Laser CO2 Versus Platelet Rich Plasma in Atrophic Scars, a Comparative Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2023 (Anticipated)
    Study Completion Date
    July 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To evaluate the efficacy of CO2 versus fractional CO2 laser versus platelet rich plasma in treatment of atrophic scars using clinical assessment and ultrasonography

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Carboxytherapy
    Arm Type
    Experimental
    Arm Description
    Device
    Arm Title
    Fractional CO2 laser
    Arm Type
    Active Comparator
    Arm Description
    Device
    Arm Title
    Platelet rich plasma
    Arm Type
    Active Comparator
    Arm Description
    platelet rich plasma
    Intervention Type
    Device
    Intervention Name(s)
    Carboxytherapy
    Intervention Description
    Device generating CO2 gas
    Primary Outcome Measure Information:
    Title
    Modified Vancouver score
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: traumatic and surgical scar Exclusion Criteria: active infections

    12. IPD Sharing Statement

    Learn more about this trial

    Carboxytherapy in the Treatment of Atrophic Scars

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