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Comparison of the Effects of Carboxytherapy and Radiofrequency on Skin Rejuvenation

NCT ID: NCT01981980

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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®.

Conditions

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Skin Aging Skin Rejuvenation

Keywords

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Carbon dioxide Carboxytherapy Radiofrequency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Carboxytherapy

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Radiofrequency

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Physical Therapy treatment

Eligibility Criteria

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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
Minimum Eligible Age

27 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Adriana Clemente Mendonça

OTHER

Sponsor Role lead

Responsible Party

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Adriana Clemente Mendonça

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Adriana C Mendonça, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Federal University of Triângulo Mineiro

Locations

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Adriana Clemente Mendonça

Uberaba, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CEP1362

Identifier Type: -

Identifier Source: org_study_id