Clinical Trials Directory

Trials / Completed

CompletedNCT01981980

Comparison of the Effects of Carboxytherapy and Radiofrequency on Skin Rejuvenation

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
8 (actual)
Sponsor
Adriana Clemente Mendonça · Academic / Other
Sex
Female
Age
27 Years – 60 Years
Healthy volunteers
Accepted

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®.

Conditions

Interventions

TypeNameDescription
OTHERCarboxytherapyCarboxytherapy 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.
OTHERRadiofrequencyThe 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.

Timeline

Start date
2009-10-01
Primary completion
2011-10-01
Completion
2013-10-01
First posted
2013-11-13
Last updated
2013-11-13

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01981980. Inclusion in this directory is not an endorsement.