Effect of Radiofrecuency on Stretch Marks

NCT03931525 | Suspended DMC

• 1 other identifier: 8042019
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stretch Marks

Keywords

Stretch Marks; Skin Disease; Diathermy; Drug Delivery Systems

Outcome Measures

Primary Outcomes (1)

• Histological changes in stretch marks

  Analysis with electronic microscopy of the percentage increase or decrease in the type and amount of collagen, as well as circulatory changes.

  a period of 30 days or 15 days post intervention

Study Arms (4)

Radiofrequency therapy with drug delivery 30 days interval

EXPERIMENTAL

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

Radiofrequency Therapy without drug delivery 30 days interval

ACTIVE COMPARATOR

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

Radiofrequency therapy with drug delivery 15 days

EXPERIMENTAL

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

Radiofrequency therapy without drug delivery 15 days

ACTIVE COMPARATOR

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

Interventions

Fractitional Radiofrecuency with Drug Delivery DEVICE

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

Radiofrequency therapy with drug delivery 15 days; Radiofrequency therapy with drug delivery 30 days interval

Fractitional Radiofrecuency DEVICE

Electromagnetic energy within the spectrum of radio frequencies applied to the skin whose purpose is to generate thermal effects

Radiofrequency Therapy without drug delivery 30 days interval; Radiofrequency therapy without drug delivery 15 days

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Quiropraxia y Equilibrio: lead

Study Sites (1)

Universidade Potiguar

Natal, Lagoa Nova, 59056-000, Brazil

Location

Related Publications (11)

• Chandrashekar BS, Sriram R, Mysore R, Bhaskar S, Shetty A. Evaluation of microneedling fractional radiofrequency device for treatment of acne scars. J Cutan Aesthet Surg. 2014 Apr;7(2):93-7. doi: 10.4103/0974-2077.138328.

  PMID: 25136209 BACKGROUND

• Fistonic I, Sorta Bilajac Turina I, Fistonic N, Marton I. Short time efficacy and safety of focused monopolar radiofrequency device for labial laxity improvement-noninvasive labia tissue tightening. A prospective cohort study. Lasers Surg Med. 2016 Mar;48(3):254-9. doi: 10.1002/lsm.22450. Epub 2016 Jan 8.

  PMID: 26748986 BACKGROUND

• Gonzalez-Suarez A, Gutierrez-Herrera E, Berjano E, Jimenez Lozano JN, Franco W. Thermal and elastic response of subcutaneous tissue with different fibrous septa architectures to RF heating: numerical study. Lasers Surg Med. 2015 Feb;47(2):183-95. doi: 10.1002/lsm.22301. Epub 2015 Feb 4.

  PMID: 25651998 BACKGROUND

• Jimenez Lozano JN, Vacas-Jacques P, Anderson RR, Franco W. Effect of fibrous septa in radiofrequency heating of cutaneous and subcutaneous tissues: computational study. Lasers Surg Med. 2013 Jul;45(5):326-38. doi: 10.1002/lsm.22146. Epub 2013 Jun 3.

  PMID: 23733512 BACKGROUND

• Key DJ. A Preliminary Study of a Transdermal Radiofrequency Device for Body Slimming. J Drugs Dermatol. 2015 Nov;14(11):1272-8.

  PMID: 26580877 BACKGROUND

• Caruth JC. Evaluation of the Safety and Efficacy of a Novel Radiofrequency Device for Vaginal Treatment. Surg Technol Int. 2018 Jun 1;32:145-149.

  PMID: 29791707 BACKGROUND

• Le Louarn C. [Midface region: functional anatomy, ageing process, indications and concentric malar lift]. Ann Chir Plast Esthet. 2009 Oct;54(5):411-20. doi: 10.1016/j.anplas.2009.04.003. Epub 2009 Aug 19. French.

  PMID: 19695761 BACKGROUND

• Sadick NS, Makino Y. Selective electro-thermolysis in aesthetic medicine: a review. Lasers Surg Med. 2004;34(2):91-7. doi: 10.1002/lsm.20013.

  PMID: 15004818 BACKGROUND

• Weiss RA. Noninvasive radio frequency for skin tightening and body contouring. Semin Cutan Med Surg. 2013 Mar;32(1):9-17.

  PMID: 24049924 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Striae Distensae; Skin Diseases; Fever

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Body Temperature Changes

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Patricia Froes Meyer, PhD

  Universidade Pontiguar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 30, 2019
• Study Start: June 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: May 1, 2025
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)