Carboxytherapy Versus Short-pulsed Nd Yag Laser in Cellulite

Not Applicable

• Conditions: Efficacy of Treatment of Cellulite Using Carboxy Therapy
• Interventions: Device: Carboxytherapy, short pulsed 1064 Nd Yag laser and subcision

• Registration Number: NCT05405062
• Lead Sponsor: Cairo University

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:

1. Females between 18 and 60 years

2. Females with cellulite; stage 2 or 3 according to Nurnberger-Muller Scale

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

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:

1. Standardized photography (posterior and side view)

2. Photonumeric cellulite severity scale (Hexsel et al., 2009)

3. 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)

4. 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:

1. Ecchymosis

2. Pain

3. Burning sensation

3- Secondary infection at injection site

Study outcomes:

1. Assessment of efficacy of carboxytherapy in the treatment of cellulite (clinically by photography and photonumeric severity scale).

2. 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.

Study Timeline

• Study First Submitted: 2022-01-07
• Status Verified: 2022-06
• Study Start: 2022-06-01
• Study First Submitted QC: 2022-06-02
• Last Update Submitted: 2022-06-02
• Study First Posted: 2022-06-03
• Last Update Posted: 2022-06-03
• Primary Completion: 2022-09-15
• Study Completion: 2022-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carboxytherapy	Carboxytherapy, short pulsed 1064 Nd Yag laser and subcision	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.
Short pulsed 1064 nm Nd-YAG laser combined with subcision	Carboxytherapy, short pulsed 1064 Nd Yag laser and subcision	Twenty-five joules/cm2, 2.2Hz combined with subcision with an interval of 1 month.

Primary Outcome Measures

Name	Time	Method
Photonumeric cellulite severity scale	Change from baseline at 3 months

Secondary Outcome Measures

Name	Time	Method
Ultrasound imaging	Change from baseline at 3 months	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)