Condition or disease | Intervention/treatment | Phase |
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Stretch Marks | Device: Fractitional Radiofrecuency with Drug Delivery Device: Fractitional Radiofrecuency | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual 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 |
Actual Study Completion Date : | May 1, 2020 |
Arm | Intervention/treatment |
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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.
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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
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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.
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Device: Fractitional Radiofrecuency
Electromagnetic energy within the spectrum of radio frequencies applied to the skin whose purpose is to generate thermal effects
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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.
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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
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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.
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Device: Fractitional Radiofrecuency
Electromagnetic energy within the spectrum of radio frequencies applied to the skin whose purpose is to generate thermal effects
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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Elimination Criteria
Brazil | |
Universidade Potiguar | |
Natal, Lagoa Nova, Brazil, 59056-000 |
Principal Investigator: | Patricia Froes Meyer, PhD | Universidade Pontiguar |
Tracking Information | |||||
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First Submitted Date ICMJE | April 25, 2019 | ||||
First Posted Date ICMJE | April 30, 2019 | ||||
Last Update Posted Date | June 9, 2020 | ||||
Actual Study Start Date ICMJE | June 1, 2019 | ||||
Actual Primary Completion Date | November 1, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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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Original Primary Outcome Measures ICMJE |
Histological changes in stretch marks [ Time Frame: a period of 30 days or 15 days post intervention ] histological changes in striae associated with increased collagen deposition, more vascularization and more fibroblasts.
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Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effect of Radiofrecuency on Stretch Marks | ||||
Official Title ICMJE | Effect of Fractional Radiofrecuency Associated Cosmetology Derug Delivery in Treatment of Strech Marks | ||||
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. | ||||
Detailed Description |
It is expected at the end of the study that the differentiated effects for conventional and Radiofrequency equipment in the dermal tissue will be demonstrated. This study intends to evaluate the Fractional Radiofrequency effects as well as the parameters to be used, seeking to confirm what the literature cites in relation to its physiological effects. A more detailed analysis of the whole process after the application is sought, not yet clearly described by scientific studies. Fractional Radiofrequency is expected to increase the increase of collagen fibers, preventing the process of natural skin aging and improving the appearance of stretch marks. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Care Provider) Primary Purpose: Treatment |
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Condition ICMJE | Stretch Marks | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
32 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | May 1, 2020 | ||||
Actual Primary Completion Date | November 1, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
Elimination Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 45 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Brazil | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03931525 | ||||
Other Study ID Numbers ICMJE | 8042019 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Hernán Andrés de la Barra Ortiz, Quiropraxia y Equilibrio | ||||
Study Sponsor ICMJE | Quiropraxia y Equilibrio | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Quiropraxia y Equilibrio | ||||
Verification Date | June 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |