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.
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.