Comparison of the Effects of Carboxytherapy and Radiofrequency on Skin Rejuvenation

Not Applicable

Completed

• Conditions: Skin Rejuvenation; Skin Aging
• Interventions: Other: Carboxytherapy; Other: Radiofrequency

• Registration Number: NCT01981980
• Lead Sponsor: Adriana Clemente Mendonça

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.

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 Timeline

• Study Start: 2009-10
• Primary Completion: 2011-10
• Study Completion: 2013-10
• Study First Submitted: 2013-10-29
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-12
• Last Update Submitted: 2013-11-12
• Study First Posted: 2013-11-13
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carboxytherapy	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.
Radiofrequency	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

Name	Time	Method
Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the same day of a single session	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

Name	Time	Method
Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the forth day after a single session	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®.

Trial Locations

Locations (1)

Adriana Clemente Mendonça; 🇧🇷 Uberaba, MG, Brazil