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Status unknownNCT05405062Updated Jun 3, 2022

Carboxytherapy Versus Short-pulsed Nd Yag Laser in Cellulite

An interventional study of Carboxytherapy, short pulsed 1064 Nd Yag laser and subcision in Efficacy of Treatment of Cellulite Using Carboxy Therapy, sponsored by Cairo University. Status unknown. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-06-03.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Efficacy of Treatment of Cellulite Using Carboxy Therapy

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03

In context

Cellulite

71 studies on the registry are indexed under Cellulite; 3 are open to participants now.

This study's planned enrollment of 30 is below the median of 34 across 65 interventional studies indexed under Cellulite.

Browse Cellulite studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, 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 or therapy
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Carboxytherapy

    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

  • Active comparator
    Short pulsed 1064 nm Nd-YAG laser combined with subcision

    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

Interventions

  • DeviceCarboxytherapy, short pulsed 1064 Nd Yag laser and subcision

    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).

06

What researchers measure

Primary outcomes

  1. Photonumeric cellulite severity scale

    Time frame: Change from baseline at 3 months

Secondary outcomes

  1. 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)

    Time frame: Change from baseline at 3 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2022; primary completion for Sep 2022, 3 months later.

Of 20 interventional studies with no phase under Cellulite, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's planned 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2022
First posted
Jun 3, 2022
StartEst.
Jun 1, 2022
Primary completionEst.
Sep 15, 2022
CompletionEst.
Sep 15, 2022
Last update
Jun 3, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05405062
Lead sponsor
Cairo University
Responsible party
Hagar El Sayed (Dr, Cairo University) — Principal investigator
First posted
Jun 3, 2022
Start date
Jun 1, 2022 (estimated)
Primary completion
Sep 15, 2022 (estimated)
Completion
Sep 15, 2022 (estimated)
Last update
Jun 3, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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