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MICRONEEDLING ON CLINICAL PARAMETERS OF STRIAE ALBA AND MORPHOLOGICAL PARAMETERS OF THE FEMALE TEGUMENTARY SYSTEM

NCT06636799 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-10-15

No results posted yet for this study

Summary

Stretch marks are dermal scars of multifactorial etiology, for which several treatments have been proposed. Among these is microneedling (MN), a technique that stimulates collagen production. However, the effects of MA alone and in combination with active agents on the length and area of stretch marks and the thickness of the integumentary system are not well understood, as the literature is scarce. Therefore, the objectives of this study were: To assess the effects of MA alone and in combination with active agents (growth factors, hyaluronic acid, and Hydroxyprolisilane CN®️) on clinical parameters (area and length) of stretch marks and morphological parameters (dermal and hypodermal thickness) of the female integumentary system. The sample was randomized into a control group (G1) that did not receive treatment, G2 that received MN alone, and G3 that received MN combined with active agents. Groups G2 and G3 underwent 3 sessions of the protocol with a 4-week interval. Groups were evaluated at the beginning and 4 months after the start of the protocol. Evaluation of the area and length of stretch marks was performed through photography, dermal and hypodermal thickness was assessed via ultrasonography, and satisfaction levels were measured using the Likert scale.

Conditions

  • Striae; Atrophy

Interventions

DEVICE

Microneedling only

In this procedure, a derma roller composed of 1.5 mm microneedles from the Smart Derma Roller brand with 540 titanium needles was used. The protocol was performed by passing the derma roller ten times in the following directions: horizontal, vertical, and diagonal right and left.

OTHER

Microneedling and actives

In this procedure, a derma roller composed of 1.5 mm microneedles from the Smart Derma Roller brand with 540 titanium needles was used. The protocol was performed by passing the derma roller ten times in the following directions: horizontal, vertical, and diagonal right and left. Group G3 received microneedling associated with active ingredients. This manipulated active ingredient was composed of growth factors (EGF Factor, TGFß3 Factor, and IDP-2 Peptide), Hydroxyprolisilane, and hyaluronic acid.

Sponsors & Collaborators

  • Isabel de Almeida Paz

    lead OTHER

Principal Investigators

  • Isabel Paz, MSc · University of Vale dos Sinos

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-01-20
Primary Completion
2024-07-20
Completion
2024-09-01

Countries

  • Brazil

Study Locations

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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 NCT06636799 on ClinicalTrials.gov