Comparison of the Effects of Carboxytherapy and Radiofrequency on Skin Rejuvenation

Skin Aging Clinical Trial

Official title:

Comparison of the Effects of Carboxytherapy and Radiofrequency on Skin Rejuvenation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01981980
• Other study ID #: CEP1362
• Status: Completed
• Phase: N/A
• First received: October 29, 2013
• Last updated: November 12, 2013
• Start date: October 2009
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Universidade Federal do Triangulo Mineiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2013
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 27 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Skin Aging
• Skin Rejuvenation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Adriana Clemente Mendonça	Uberaba	MG

Sponsors (1)

Lead Sponsor	Collaborator
Adriana Clemente Mendonça

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Other	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	Yes
Other	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	Yes
Other	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	Yes
Other	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	Yes
Other	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	Yes
Primary	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	Yes
Secondary	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	Yes