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

October 8, 2024 updated by: Isabel de Almeida Paz

EFFECTS OF MICRONEEDLING ON CLINICAL PARAMETERS OF STRIAE ALBA AND MORPHOLOGICAL PARAMETERS OF THE FEMALE TEGUMENTARY SYSTEM: A RANDOMIZED CLINICAL TRIAL

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was a randomized clinical trial in blocks with a 1:1 allocation, stratified by weight. The study was duly adapted to resolution 466/12 of the National Health Council on research involving human beings and to the Declaration of Helsinki. The evaluations and treatment protocols were carried out at the Physiotherapy Clinic of a Private Higher Education Institution.. The sample was characterized by convenience and healthy women who met the inclusion criteria were recruited, mainly via social networks. To calculate the sample size, the G-Power software (version 3.1.3; University of Trier, Trier, Germany) was used and the significance level adopted was α = 0.05 and power (1-β) = 0.80. No similar studies were found, so f 0.30 was used as the effect size. Therefore, the minimum number of participants required for the study was estimated at 24 participants. Considering possible losses during the protocol, 26 participants (+10%) were recruited. Randomization was performed by stratifying by weight. The randomization list was kept in opaque and sealed envelopes, ensuring that the allocation was hidden and random and that the therapist responsible for applying the microneedling had contact with the randomization only on the day of the protocol application. In the present study, the sample of 26 participants was divided into three groups. Group one (G1), control, composed of eight people, underwent all the evaluations, but did not receive the microneedling protocol or actives. Group two (G2), composed of nine people, underwent all the proposed evaluations and the isolated microneedling procedure. Group three (G3), composed of nine people, underwent all the proposed evaluations and the microneedling procedure associated with actives. 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.This study adopted the intention-to-treat approach. Therefore, participants who did not attend the scheduled sessions were rescheduled, allowing all sessions planned to be carried out. When the decision was made to withdraw, the data collected up until the end were used for analysis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • São Leopoldo, Rio Grande Do Sul, Brazil, 93.022-750
        • Universidade do Vale do Rio dos Sinos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy women (self-declaration of no diseases)
  • Age between 18 and 35 years
  • Presence of striae alba in the gluteal region

Exclusion Criteria:

  • Health problems (cardiovascular, neurological, or musculoskeletal impairment)
  • History of keloids
  • Allergic disorders
  • Skin cancer
  • Systemic disease
  • Diabetes mellitus
  • Pregnant women
  • Lactating women
  • Psoriasis sufferers
  • Hypersensitivity
  • Use of peels, lasers, or any similar treatment in the last three months or any contraindication for performing microneedling.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Microneedling only
In this procedure, only the derma roller composed of 1.5 mm microneedles from the Smart Derma Roller brand with 540 titanium needles was used.
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.
Active Comparator: Microneedling associated with actives
In this procedure, a derma roller composed of 1.5 mm microneedles from the Smart Derma Roller brand with 540 titanium needles associated with active ingredients were used.
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.
No Intervention: Control
This group did not receive intervention but participated in pre- and post-protocol assessments.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The area of stretch marks
Time Frame: 30 minutes
Photographic image analysis was performed before and after the protocol.These images will be analyzed later by tracing the area of the entire stria.
30 minutes
The thickness of stretch marks
Time Frame: 30 minutes
Photographic image analysis was performed before and after the protocol. These images will be analyzed later by drawing a line between the upper and lower edges of the stria.
30 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Skin thickness
Time Frame: 30 minutes
Ultrasound images collected before the first session and 30 days after the last session were analyzed. These images will be examined later, and the thickness of the skin will be evaluated.
30 minutes
Likert scale of patient satisfaction
Time Frame: 20 minutes
A questionnaire was used to assess the level of satisfaction through non-standardized questions. Therefore, for adequate evaluation, in this study, patients undergoing microneedling post-treatment were asked about their level of satisfaction with the color, length and width of stretch marks, final skin quality, time of treatment and quality of care.
20 minutes
Hypodermis thickness
Time Frame: 30 minutes
Ultrasound images collected before the first session and 30 days after the last session were analyzed. These images will be examined later, and the thickness of the hypodermis will be evaluated.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Isabel de Almeida Paz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Isabel Paz, MSc, University of Vale dos Sinos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6.584.696

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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