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Effect of Radiofrecuency on Stretch Marks (FRF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931525
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Hernán Andrés de la Barra Ortiz, Quiropraxia y Equilibrio

Brief Summary:
This study aims to explore the effects of fractional Radiofrecuency (RF), as well as demonstrate the performance of the new semi-ablative radiofrequency model in the treatment of stretch marks. This research is a randomized, controlled clinical trial where 32 female patients complaining of glutes and / or abdomen striations. The participants were divided into two equal groups, G1 and G2. G1 will be treated at 30-day intervals, and subdivided into 2 subgroups: G1A, 8 patients with striations in the abdomen; and G1B, 8 patients with gluteal striations. The G1A and G1B groups will be divided into 2 subgroups of 4 people each, where one group will be treated with Fractional RF associated to drug delivery, and the other group, with only Fractional RF, without the application of drug delivery. The same rule of subdivisions will occur in G2, G2A and G2B, however, the interval between applications will be every 15 days. The treatment area will be divided into a rectangle 10cm high by 10cm wide. For evaluation, the contralateral side will be used as a control, using Photogrammetry and histological analysis as a resource, which will be collected through the punch skin fragment of the infraumbilical and gluteal region, performed by a specialized physician.

Condition or disease Intervention/treatment Phase
Stretch Marks Device: Fractitional Radiofrecuency with Drug Delivery Device: Fractitional Radiofrecuency Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Fractional Radiofrecuency Associated Cosmetology Derug Delivery in Treatment of Strech Marks
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : November 1, 2019
Estimated Study Completion Date : May 1, 2020

Arm Intervention/treatment
Experimental: Radiofrequency therapy with drug delivery 30 days interval
Group that will be treated with Fractional Radiofrequency plus a regerative drug at the Gluteus or Abdomen level during 4 sessions with an interval of 30 days.
Device: Fractitional Radiofrecuency with Drug Delivery
Electromagnetic energy within the spectrum of radio frequencies applied to the skin whose purpose is to generate thermal effects and which will be complemented with a skin drug

Active Comparator: Radiofrequency Therapy without drug delivery 30 days interval
Group that will be treated with Fractional Radiofrequency at the Gluteus or Abdomen level during 4 sessions with an interval of 30 days.
Device: Fractitional Radiofrecuency
Electromagnetic energy within the spectrum of radio frequencies applied to the skin whose purpose is to generate thermal effects

Experimental: Radiofrequency therapy with drug delivery 15 days
Group that will be treated with Fractional Radiofrequency plus a regerative drug at the Gluteus or Abdomen level during 4 sessions with an interval of 15 days.
Device: Fractitional Radiofrecuency with Drug Delivery
Electromagnetic energy within the spectrum of radio frequencies applied to the skin whose purpose is to generate thermal effects and which will be complemented with a skin drug

Active Comparator: Radiofrequency therapy without drug delivery 15 days
Group that will be treated with Fractional Radiofrequency at the Gluteus or Abdomen level during 4 sessions with an interval of 15 days.
Device: Fractitional Radiofrecuency
Electromagnetic energy within the spectrum of radio frequencies applied to the skin whose purpose is to generate thermal effects




Primary Outcome Measures :
  1. Histological changes in stretch marks [ Time Frame: a period of 30 days or 15 days post intervention ]
    Analysis with electronic microscopy of the percentage increase or decrease in the type and amount of collagen, as well as circulatory changes.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women over 18 and not older than 45 years
  • Presence Gluteal and Abdominal Striae.
  • Stretch marks aesthetic discomfort

Exclusion Criteria:

  • Malignancy.
  • Metal implants or abdominal or pelvic stents
  • Presence of collagen diseases.
  • Alteration in the synthesis of proteins.
  • Alterations of the integrity of the skin such as burns, wounds, keloids, hypertrophic scars or dermatitis.
  • Intake of steroidal and nonsteroidal anti-inflammatory drugs.
  • Hypocaloric diet indicated by nutritionist.
  • Do not agree with the intervention protocol.

Elimination Criteria

  • Non-tolerance of the intervention with electrotherapy that requires the suspension of treatment.
  • Non-completion of the evaluation protocol (Attendance at all scheduled sessions).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931525


Contacts
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Contact: Julio D Costa e Silva +55 84 999090888 juliocostaa@outlook.com
Contact: Hernán A de la Barra, Mg. +56 9 84706322 hdelabarra@unab.cl

Locations
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Brazil
Universidade Potiguar Recruiting
Natal, Lagoa Nova, Brazil, 59056-000
Contact: Julio D Costa e Silva    +55 84 999090888    juliocostaa@outlook.com   
Contact: Hernán A de la Barra, Mg.    +56 984706322    hdelabarra@unab.cl   
Principal Investigator: Julio D Costa e Silva, Mg.         
Principal Investigator: Patricia Froes Meyer, PhD         
Sub-Investigator: Hernán A de la Barra, Mg.         
Sponsors and Collaborators
Quiropraxia y Equilibrio
Investigators
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Principal Investigator: Patricia Froes Meyer, PhD Universidade Pontiguar

Publications:
Casabona G et al. Radiofrequência ablativa fracionada: um estudo piloto com 20 casos para rejuvenescimento da pálpebra inferior. Surg Cosmet Dermatol 2014;6(1):505.
Crocco, E.I.; Mantovani, P. A.;Volpini, B.M.F. Em Busca Dos Tratamentos Para Striae Rubra E Striae Alba: O Desafio Do Dermatologista. Surgical & Cosmetic Dermatology, V.4, N.4, P.332-337, 2012.

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Responsible Party: Hernán Andrés de la Barra Ortiz, Clinical Professor, Quiropraxia y Equilibrio
ClinicalTrials.gov Identifier: NCT03931525    
Other Study ID Numbers: 8042019
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hernán Andrés de la Barra Ortiz, Quiropraxia y Equilibrio:
Stretch Marks
Skin Disease
Diathermy
Drug Delivery Systems
Additional relevant MeSH terms:
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Striae Distensae
Skin Manifestations
Signs and Symptoms