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.

Study Overview

• Status: Completed
• Conditions: Skin Aging; Skin Rejuvenation
• Intervention / Treatment: Other: Carboxytherapy; Other: Radiofrequency

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®.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • MG
    • Uberaba, MG, Brazil, 38015050
      • Adriana Clemente Mendonça

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 27 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the same day of 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®.	same 1 day of a single session treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the forth 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®.	4th day after a single session

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 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®.	20th day after a single session
Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 28th 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®.	28th day after a single
Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 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®.	44th day after a single session
Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 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®.	61th day after a single session
Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 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®.	117th day after a single session
Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 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®.	120th day after a single session

Collaborators and Investigators

• Sponsor: Adriana Clemente Mendonça
• Investigators: Principal Investigator: Adriana C Mendonça, Ph.D., Federal University of Triângulo Mineiro

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: October 29, 2013
• First Submitted That Met QC Criteria: November 12, 2013
• First Posted (Estimate): November 13, 2013

Study Record Updates

• Last Update Posted (Estimate): November 13, 2013
• Last Update Submitted That Met QC Criteria: November 12, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Radiofrequency; Carbon dioxide; Carboxytherapy
• Other Study ID Numbers: CEP1362