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Comparison of the Effects of Carboxytherapy and Radiofrequency on Skin Rejuvenation

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ClinicalTrials.gov Identifier: NCT01981980
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : November 13, 2013
Sponsor:
Information provided by (Responsible Party):
Adriana Clemente Mendonça, Universidade Federal do Triangulo Mineiro

Brief Summary:
Carboxytherapy (CA) refers to the cutaneous and subcutaneous administration of carbon dioxide gas [CO2] for therapeutic purposes. Radiofrequency (RF) is a method that uses electric current to generate heat into the layers of the skin and the subcutaneous tissue. Both techniques are indicated to the treatment of skin laxity. The aim of this study was to compare the effects of CA an RF on human skin. Methods: Eight patients who underwent abdominoplasty surgery received a single procedure of both treatments. Untreated skin was used as control. In an area of 49 cm2 (7 x 7 cm) in the infra-umbilical region CA was performed on the right and RF on the left side. Sample collection period ranged from zero to 120 days. CA was administered at a velocity of 40 ml/min, and the total quantity of CO2 infused was approximately 20ml. RF was carried out in a temperature higher than 40ºC on the epidermis for 5 minutes after reaching this temperature.

Condition or disease Intervention/treatment Phase
Skin Aging Skin Rejuvenation Other: Carboxytherapy Other: Radiofrequency Not Applicable

Detailed Description:
Untreated skin was used as control. In an area of 49 cm2 (7 x 7 cm) in the infra-umbilical region CA was performed on the right side and RF on the left side. CA was administered using the beveled end of a 30G ½ needle introduced in the skin in an angle of approximately 30ºC and delivered at a velocity of 40 mL/min. The total quantity of CO2 infused was approximately 20 mL (0,3 to 0,6 mL/kg of patient's body weight) encompassing the whole delimited are. For the RF treatment, the epidermal temperature was controlled using an infrared thermometer monitored to reach 40ºC and treatment time was of five minutes starting after having reached this temperature. Sample collection varied from zero to 120 days after application. The samples were then fixed, cut in paraffin (5 µm) and stained with Picro sirus and Weigert. Morphological analyses were acquired using a Zeiss Axiophot® microscope, and they were processed using Adobe Photoshop®.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comparison of the Effects of Carboxytherapy and Radiofrequency on Skin Rejuvenation
Study Start Date : October 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: Carboxytherapy
It was administered using the beveled end of a 30G ½ needle introduced in the skin in an angle of approximately 30ºC and delivered at a velocity of 40 mL/min. The total quantity of CO2 infused was approximately 20 mL (0,3 to 0,6 mL/kg of patient's body weight) encompassing the whole delimited area.
Other: Carboxytherapy
Carboxytherapy was performed on the right side and RF on the left side. CA was administered using the beveled end of a 30G ½ needle introduced in the skin in an angle of approximately 30ºC and delivered at a velocity of 40 mL/min. The total quantity of CO2 infused was approximately 20 mL (0,3 to 0,6 mL/kg of patient's body weight) encompassing the whole delimited area.
Other Name: Physical Therapy treatment

Experimental: Radiofrequency
The epidermal temperature was controlled using an infrared thermometer monitored to reach 40ºC and treatment time was of five minutes starting after having reached this temperature.
Other: Radiofrequency
The epidermal temperature was controlled using an infrared thermometer monitored to reach 40ºC and treatment time was of five minutes starting after having reached this temperature.




Primary Outcome Measures :
  1. Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the same day of a single session [ Time Frame: same 1 day of a single session treatment ]
    Evaluation of elastic fiber and collagen remodeling from skin treated or not with Carboxytherapy and Radiofrequency. Samples were obtained from one patient who underwent abdominoplasty surgery. The samples were fixed, processed to paraffin and stained with Picro sirus and Weigert. Images were acquired using a Zeiss Axiophot® microscope, and they were processed using Adobe Photoshop®.


Secondary Outcome Measures :
  1. Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the forth day after a single session [ Time Frame: 4th day after a single session ]
    Evaluation of elastic fiber and collagen remodeling from skin treated or not with Carboxytherapy and Radiofrequency. Samples were obtained from one patient who underwent abdominoplasty surgery. The samples were fixed, processed to paraffin and stained with Picro sirus and Weigert. Images were acquired using a Zeiss Axiophot® microscope, and they were processed using Adobe Photoshop®.


Other Outcome Measures:
  1. Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 20th day after a single session [ Time Frame: 20th day after a single session ]
    Evaluation of elastic fiber and collagen remodeling from skin treated or not with Carboxytherapy and Radiofrequency. Samples were obtained from one patient who underwent abdominoplasty surgery. The samples were fixed, processed to paraffin and stained with Picro sirus and Weigert. Images were acquired using a Zeiss Axiophot® microscope, and they were processed using Adobe Photoshop®.

  2. Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 28th day after a single session [ Time Frame: 28th day after a single ]
    Evaluation of elastic fiber and collagen remodeling from skin treated or not with Carboxytherapy and Radiofrequency. Samples were obtained from one patient who underwent abdominoplasty surgery. The samples were fixed, processed to paraffin and stained with Picro sirus and Weigert. Images were acquired using a Zeiss Axiophot® microscope, and they were processed using Adobe Photoshop®.

  3. Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 44th day after a single session [ Time Frame: 44th day after a single session ]
    Evaluation of elastic fiber and collagen remodeling from skin treated or not with Carboxytherapy and Radiofrequency. Samples were obtained from one patient who underwent abdominoplasty surgery. The samples were fixed, processed to paraffin and stained with Picro sirus and Weigert. Images were acquired using a Zeiss Axiophot® microscope, and they were processed using Adobe Photoshop®.

  4. Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 61th day after a single session [ Time Frame: 61th day after a single session ]
    Evaluation of elastic fiber and collagen remodeling from skin treated or not with Carboxytherapy and Radiofrequency. Samples were obtained from one patient who underwent abdominoplasty surgery. The samples were fixed, processed to paraffin and stained with Picro sirus and Weigert. Images were acquired using a Zeiss Axiophot® microscope, and they were processed using Adobe Photoshop®.

  5. Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 117th day after a single session [ Time Frame: 117th day after a single session ]
    Evaluation of elastic fiber and collagen remodeling from skin treated or not with Carboxytherapy and Radiofrequency. Samples were obtained from one patient who underwent abdominoplasty surgery. The samples were fixed, processed to paraffin and stained with Picro sirus and Weigert. Images were acquired using a Zeiss Axiophot® microscope, and they were processed using Adobe Photoshop®.

  6. Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 120th day after a single session [ Time Frame: 120th day after a single session ]
    Evaluation of elastic fiber and collagen remodeling from skin treated or not with Carboxytherapy and Radiofrequency. Samples were obtained from one patient who underwent abdominoplasty surgery. The samples were fixed, processed to paraffin and stained with Picro sirus and Weigert. Images were acquired using a Zeiss Axiophot® microscope, and they were processed using Adobe Photoshop®.



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Ages Eligible for Study:   27 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients who underwent abdominoplasty surgery and agree to participate to this study

Exclusion Criteria:

  • patients been treated with corticosteroids or anti-inflammatory during the period of the protocol, with cancer or other change that contraindicated the application of carboxytherapy and radiofrequency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981980


Locations
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Brazil
Adriana Clemente Mendonça
Uberaba, MG, Brazil, 38015050
Sponsors and Collaborators
Adriana Clemente Mendonça
Investigators
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Principal Investigator: Adriana C Mendonça, Ph.D. Federal University of Triângulo Mineiro

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Responsible Party: Adriana Clemente Mendonça, Professor, Universidade Federal do Triangulo Mineiro
ClinicalTrials.gov Identifier: NCT01981980     History of Changes
Other Study ID Numbers: CEP1362
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013
Keywords provided by Adriana Clemente Mendonça, Universidade Federal do Triangulo Mineiro:
Carbon dioxide
Carboxytherapy
Radiofrequency