MedTrace Logo

Effect of Radiofrecuency on Stretch Marks

NCT03931525 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-06-17

No results posted yet for this study

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

Interventions

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

DEVICE

Fractitional Radiofrecuency

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

Sponsors & Collaborators

  • Quiropraxia y Equilibrio

    lead OTHER

Principal Investigators

  • Patricia Froes Meyer, PhD · Universidade Pontiguar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2019-11-01
Completion
2025-05-01

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03931525 on ClinicalTrials.gov