Effect of Fractional Radiofrecuency Associated Cosmetology Derug Delivery in Treatment of Strech Marks
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Histological changes in stretch marks
Study Overview
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
- INTRODUCTION
Stretch marks are characterized by common dermatological conditions, being aesthetically unpleasant, disturbing especially women of different age groups. Analyzing the histological aspect, they present as atrophic lesions that disperse collagen and elastic tissue, in addition to reducing the presence of skin cells such as keratinocytes, melanocytes and fibroblasts.
It is noted that the striations may be distributed locally or numerously, disposed parallel to one another and perpendicular to the skin cleavage lines. At the beginning, the striae appear erythematous-violet, thin and may generate pruritus, characterizing its inflammatory phase.
When the inflammatory phase passes, the striations develop into an atrophic condition, they acquire a whitish appearance, almost pearly, becoming wider, due to the rupture of elastic and collagen fibers.
Dermatofunctional physiotherapy already has several resources to treat these effects, such as therapeutic ultrasound, cryolipolysis, radiofrequency, low intensity laser and high intensity focused ultrasound. RF heating is commonly used to cause shrinkage of dermal collagen and induce stimulation of fibroblast cells that produce a new collagen.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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).
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported