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

NCT06636799 | Completed DMC

• 1 other identifier: 6.584.696
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• The area of stretch marks

  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

  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 Outcomes (3)

• Skin thickness

  30 minutes

• Likert scale of patient satisfaction

  20 minutes

• Hypodermis thickness

  30 minutes

Study Arms (3)

Microneedling only

EXPERIMENTAL

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

Microneedling associated with actives

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

This group did not receive intervention but participated in pre- and post-protocol assessments.

Interventions

Microneedling only DEVICE

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.

Microneedling only

Microneedling and actives OTHER

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.

Microneedling associated with actives

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Isabel de Almeida Paz: lead

Study Sites (1)

Universidade do Vale do Rio dos Sinos

São Leopoldo, Rio Grande do Sul, 93.022-750, Brazil

Location

MeSH Terms

Conditions

Striae Distensae; Atrophy

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• Isabel Paz, MSc

  University of Vale dos Sinos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 15, 2024
• Study Start: January 20, 2024
• Primary Completion: July 20, 2024
• Study Completion: September 1, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

BR (1)