Carboxytherapy Versus Short-pulsed Nd Yag Laser in Cellulite

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Carboxytherapy Versus Short-pulsed 1064 nm Nd-YAG Laser Combined With Subcision in Treatment of Cellulite

Conditions
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Efficacy of Treatment of Cellulite Using Carboxy Therapy

Intervention / Treatment
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* Device: Carboxytherapy, short pulsed 1064 Nd Yag laser and subcision


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carboxytherapy<br>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. | Device: Carboxytherapy, short pulsed 1064 Nd Yag laser and subcision<br>* 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).<br>|
| Active Comparator: Short pulsed 1064 nm Nd-YAG laser combined with subcision<br>Twenty-five joules/cm2, 2.2Hz combined with subcision with an interval of 1 month. | Device: Carboxytherapy, short pulsed 1064 Nd Yag laser and subcision<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photonumeric cellulite severity scale |  | Change from baseline at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Change from baseline at 3 months |