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Carboxytherapy Versus Short-pulsed Nd Yag Laser in Cellulite

Primary Purpose

Efficacy of Treatment of Cellulite Using Carboxy Therapy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carboxytherapy, short pulsed 1064 Nd Yag laser and subcision
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Efficacy of Treatment of Cellulite Using Carboxy Therapy

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Females between 18 and 60 years
  2. Females with cellulite; stage 2 or 3 according to Nurnberger-Muller Scale (Nurnberger and Muller, 1978)

Exclusion Criteria:

  1. Subjects that have had liposuction or surgical procedures to remove fat in the past 6 months
  2. Personal or family history of keloid formation or scarring
  3. Pregnant or lactating females
  4. Significant concomitant illness (e.g. renal, cardiac, hepatic, autoimmune conditions)
  5. Known history of bleeding tendency or receiving antiplatelet or anticoagulant therapy
  6. History of uncontrolled diabetes
  7. History of thrombophlebitis within the last 2 years
  8. Subjects with active infections
  9. Subjects on long term corticosteroid or immunosuppressive therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Carboxytherapy

    Short pulsed 1064 nm Nd-YAG laser combined with subcision

    Arm Description

    Six carboxytherapy sessions with an interval of 2 weeks. Five ccs will be injected at each point with a depth of 7mm. Between each point and the other is 5 cm.

    Twenty-five joules/cm2, 2.2Hz combined with subcision with an interval of 1 month.

    Outcomes

    Primary Outcome Measures

    Photonumeric cellulite severity scale

    Secondary Outcome Measures

    Ultrasound imaging
    The device used is Toshiba with high frequency probes: probe 18-20 MHz (for measuring skin dermal thickness) and probe 7-9MHz (for measuring subcutaneous fat thickness)

    Full Information

    First Posted
    January 7, 2022
    Last Updated
    June 2, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05405062
    Brief Title
    Carboxytherapy Versus Short-pulsed Nd Yag Laser in Cellulite
    Official Title
    Efficacy of Carboxytherapy Versus Short-pulsed 1064 nm Nd-YAG Laser Combined With Subcision in Treatment of Cellulite
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2022 (Anticipated)
    Primary Completion Date
    September 15, 2022 (Anticipated)
    Study Completion Date
    September 15, 2022 (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 carboxytherapy versus short-pulsed 1064 nm Nd-YAG laser combined with subcision in treatment of cellulite using clinical assessment and ultrasound imaging.
    Detailed Description
    Study Design: Randomized Clinical Trial Study Methods: The population of study: Thirty females aged from 18 to 60 years with cellulite Study location: Dermatology outpatient clinic, Faculty of Medicine, Cairo University Inclusion criteria: Females between 18 and 60 years Females with cellulite; stage 2 or 3 according to Nurnberger-Muller Scale Exclusion criteria: Subjects that have had liposuction or surgical procedures to remove fat in the past 6 months Personal or family history of keloid formation or scarring Pregnant or lactating females Significant concomitant illness (e.g. renal, cardiac, hepatic, autoimmune conditions) Known history of bleeding tendency or receiving antiplatelet or anticoagulant therapy History of uncontrolled diabetes History of thrombophlebitis within the last 2 years Subjects with active infections Subjects on long term corticosteroid or immunosuppressive therapy All patients will be subjected to the following: An informed written consent will be obtained from all the patients. Patients will be examined to assess site, stage and severity of cellulite. Depressed areas on gluteal region and posterolateral thighs will be selected and marked while the patient is standing. One side will be randomized to receive 6 carboxytherapy sessions with an interval of 2 weeks. The other side will receive 3 sessions of short pulsed 1064 nm Nd-YAG laser (25 joules/cm2, 2.2Hz) combined with subcision with an interval of 1 month. In carboxytherapy, 5 cc will be injected in each point with depth of 7mm. Between each point and the other is 5 cm. Subcision will be done in the center of the selected dimples. Systemic antibiotics will be prescribed for 5 days after subcision session. The whole duration of the sessions is 3 months. Patients will be advised to maintain a healthy diet throughout the study. Evaluation of patients' response: A complete physical examination and history taking before treatment Evaluation will be carried out for each patient at the beginning of the study, and at the end of the study 2 weeks following the final session by: Standardized photography (posterior and side view) Photonumeric cellulite severity scale (Hexsel et al., 2009) Ultrasound imaging that measures percentage of reduction of subcutaneous fat and dermal thickness. The device used is Toshiba with high frequency probes: probe 18-20 MHz (for measuring skin dermal thickness) and probe 7-9MHz (for measuring subcutaneous fat thickness) Patient satisfaction scoring will be reported at the end of the study by patient satisfaction score (excellent, very good, good, bad, very bad) and DLQI score (Finlay and Khan, 1994). Potential risks: Ecchymosis Pain Burning sensation 3- Secondary infection at injection site Study outcomes: Assessment of efficacy of carboxytherapy in the treatment of cellulite (clinically by photography and photonumeric severity scale). Evaluating possible synergistic effect of short pulsed Nd-YAG laser combined with subcision in treatment of cellulite (clinically by photography and photonumeric severity scale). Secondary outcome: Comparing the reduction in subcutaneous fat and change in dermal thickness between the 2 methods by ultrasound imaging.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Efficacy of Treatment of Cellulite Using Carboxy Therapy

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Carboxytherapy
    Arm Type
    Active Comparator
    Arm Description
    Six carboxytherapy sessions with an interval of 2 weeks. Five ccs will be injected at each point with a depth of 7mm. Between each point and the other is 5 cm.
    Arm Title
    Short pulsed 1064 nm Nd-YAG laser combined with subcision
    Arm Type
    Active Comparator
    Arm Description
    Twenty-five joules/cm2, 2.2Hz combined with subcision with an interval of 1 month.
    Intervention Type
    Device
    Intervention Name(s)
    Carboxytherapy, short pulsed 1064 Nd Yag laser and subcision
    Intervention Description
    Carboxytherapy is involves the injection of carbon dioxide into the subcutaneous tissue, with the goal of affecting the adipose tissue and circulation. Its mechanism of action is through an increase in capillary blood flow induced by hypercapnia and a decrease in cutaneous oxygen consumption (Pianez et al., 2016).
    Primary Outcome Measure Information:
    Title
    Photonumeric cellulite severity scale
    Time Frame
    Change from baseline at 3 months
    Secondary Outcome Measure Information:
    Title
    Ultrasound imaging
    Description
    The device used is Toshiba with high frequency probes: probe 18-20 MHz (for measuring skin dermal thickness) and probe 7-9MHz (for measuring subcutaneous fat thickness)
    Time Frame
    Change from baseline at 3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Females between 18 and 60 years Females with cellulite; stage 2 or 3 according to Nurnberger-Muller Scale (Nurnberger and Muller, 1978) Exclusion Criteria: Subjects that have had liposuction or surgical procedures to remove fat in the past 6 months Personal or family history of keloid formation or scarring Pregnant or lactating females Significant concomitant illness (e.g. renal, cardiac, hepatic, autoimmune conditions) Known history of bleeding tendency or receiving antiplatelet or anticoagulant therapy History of uncontrolled diabetes History of thrombophlebitis within the last 2 years Subjects with active infections Subjects on long term corticosteroid or immunosuppressive therapy

    12. IPD Sharing Statement

    Learn more about this trial

    Carboxytherapy Versus Short-pulsed Nd Yag Laser in Cellulite

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