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