Comparison of the Effects of Carboxytherapy and Radiofrequency on Skin Rejuvenation

NCT01981980 | Completed

• 1 other identifier: CEP1362
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Aging; Skin Rejuvenation

Keywords

Carbon dioxide; Carboxytherapy; Radiofrequency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the forth day after a single session

  4th day after a single session

Other Outcomes (6)

• Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 20th day after a single session

  20th day after a single session

• Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 28th day after a single session

  28th day after a single

• Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 44th day after a single session

  44th day after a single session

Study Arms (2)

Carboxytherapy

EXPERIMENTAL

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

Radiofrequency

EXPERIMENTAL

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

Interventions

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.

Also known as: Physical Therapy treatment

Carboxytherapy

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.

Radiofrequency

Eligibility Criteria

• Age: 27 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adriana Clemente Mendonça: lead

Study Sites (1)

Adriana Clemente Mendonça

Uberaba, Minas Gerais, 38015050, Brazil

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Adriana C Mendonça, Ph.D.

  Federal University of Triângulo Mineiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 13, 2013
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2013
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

BR (1)