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Completed

NCT Number: NCT01981980

Comparison of the Effects of Carboxytherapy and Radiofrequency on Skin Rejuvenation

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.

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Key information

Conditions

Skin Aging Skin Rejuvenation

Age range

27 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Adriana Clemente Mendonça

Uberaba, Minas Gerais, 38015050, Brazil

About this study

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®.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carboxytherapy

Other

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 names: Physical Therapy treatment

Radiofrequency

Other

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 outcomes

  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 outcomes

  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 outcomes

  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®.

Sponsors and collaborators

Lead sponsor

Adriana Clemente Mendonça

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Nov 13, 2013
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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