Clinical trial NCT01981980: Comparison of the Effects of Carboxytherapy and Radiofrequency on Skin Rejuvenation
Official title: Comparison of the Effects of Carboxytherapy and Radiofrequency on Skin Rejuvenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Skin Rejuvenation
Keywords: Carbon dioxide
Carboxytherapy
Radiofrequency
Lead sponsor: Universidade Federal do Triangulo Mineiro
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 8
Sex: FEMALE
Minimum age (years): 27
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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®.

Eligibility criteria: 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

Primary outcomes:
measure: Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the same day of a single session
timeFrame: same 1 day of a single session treatment
Secondary outcomes:
measure: Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the forth day after a single session
timeFrame: 4th day after a single session
Other outcomes:
measure: Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 20th day after a single session
timeFrame: 20th day after a single session
measure: Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 28th day after a single session
timeFrame: 28th day after a single
measure: Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 44th day after a single session
timeFrame: 44th day after a single session
measure: Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 61th day after a single session
timeFrame: 61th day after a single session
measure: Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 117th day after a single session
timeFrame: 117th day after a single session
measure: Effect on Skin morphology treatment with Carboxytherapy and Radiofrequency at the 120th day after a single session
timeFrame: 120th day after a single session
Locations:
city: Uberaba
country: Brazil
facility: Adriana Clemente Mendonça
state: MG
Study officials:
affiliation: Federal University of Triângulo Mineiro
name: Adriana C Mendonça, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: