Effects of Microgalvanic Current on Body Satisfaction and Quality of Life in Women With Striae Alba

Effects of Microgalvanic Current as an Adjunct Intervention on Body Satisfaction and Quality of Life in Women With Striae Alba: a Randomized Clinical Trial.

The purpose of this randomized clinical trial is to determine whether microgalvanic current can improve quality of life and body satisfaction in women aged 20 to 35 years with striae albae (white stretch marks).

The primary research question is: Does microgalvanic current improve body satisfaction or quality of life? The secondary research question is: Does microgalvanic current lead to clinical improvement of striae albae? Participants will be randomly assigned to one of two groups: Control group: device turned off, receiving microneedling only; and Intervention group: active device, receiving microneedling combined with microgalvanic current.

All participants will undergo 10 weekly treatment sessions, each lasting approximately 50 minutes. Baseline and post-intervention assessments will be conducted to evaluate primary and secondary outcomes. Standardized photographs of the affected areas will be obtained to assess clinical improvement.

Study Overview

• Status: Completed
• Conditions: White Stretch Marks (Striae Albae)
• Intervention / Treatment: Procedure: Control group placebo; Procedure: Microneedling + Microgalvanic Current

Detailed Description

This randomized clinical trial will use a controlled parallel-arm design to evaluate the effects of microgalvanic current combined with microneedling on striae albae in women aged 20 to 35 years. Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive microgalvanic current delivered through a specialized device simultaneously with microneedling. The control group will receive microneedling only, with the device turned off. Each participant will undergo 10 weekly treatment sessions, each lasting approximately 50 minutes. The treated area will be standardized across participants. Standardized digital photographs will be obtained at baseline and after completion of the 10th treatment session using consistent positioning and lighting conditions (no flash, no filters, no image editing). Images will be stored securely. Pain perception will be assessed at each session using the Visual Analog Scale (VAS). The Fitzpatrick Skin Phototype Scale will be applied at baseline to classify skin type and explore its potential influence on treatment response.

Standardized safety and hygiene protocols will be implemented, including the use of disposable or sterilized microneedling devices, appropriate disinfection of the treatment area, and monitoring for adverse events such as erythema, bleeding, or infection. Any complications will be documented and managed according to clinical protocols.

All collected data, including photographic records, questionnaire responses, and VAS scores, will be stored in password-protected systems accessible only to the research team. Data analysis will focus on changes in body satisfaction, quality of life, and clinical improvement of striae albae, as well as exploratory analyses of skin phototype and treatment tolerability.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Diamantina, Minas Gerais, Brazil, 39100000
      • Federal University of Jequitinhonha and Mucuri Valleys

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Biologically female individuals
• Age between 20 and 35 years
• Presence of white stretch marks (striae albae)
• Availability to participate for the entire duration of the study
• Properly and completely signed Informed Consent Form, Image Use Agreement and all study questionnaires

Exclusion Criteria:

• Cardiac arrhythmia or pacemaker
• Hemophilia
• Uncontrolled arterial hypertension
• Diabetes mellitus
• Predisposition to keloid formation
• Hypersensitivity to electrical current stimulation
• Pregnancy
• Any abnormalities or diseases (e.g., Cushing's syndrome) that impair skin healing
• Open wounds
• Current or recent use of corticosteroids, steroids or anti-inflammatory medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sham Microgalvanic Current; Participants in this group will receive microneedling treatment only, using the device turned off. This allows evaluation of the effects of microneedling without the microgalvanic current. Pre- and post-intervention assessments will be conducted to measure body satisfaction, quality of life, and clinical improvement of white stretch marks (striae albae). Photographs of the affected areas will be taken during each session.	Procedure: Control group placebo; Participants in this group will receive microneedling treatment with the device turned off, providing only the mechanical stimulation of microneedling without the microgalvanic current. This allows evaluation of the effects of microneedling alone. The procedure consists of 10 weekly sessions lasting approximately 50 minutes each. Photographs of the affected areas will be taken during each session.; Other Names: Microneedling (Device Off)
Experimental: Microgalvanic Current; Participants in this group will receive microneedling combined with active microgalvanic current using the device. This allows evaluation of the combined effects of microneedling and microgalvanic current on body satisfaction, quality of life, and clinical improvement of white stretch marks (striae albae). Pre- and post-intervention assessments and photographs will be collected in each session.	Procedure: Microneedling + Microgalvanic Current; Participants in this group will receive microneedling combined with active microgalvanic current using the same device. This procedure aims to evaluate the combined effects of microneedling and galvanic current on body satisfaction, quality of life, and the clinical appearance of white stretch marks (striae albae). The procedure consists of 10 weekly sessions lasting approximately 50 minutes each. Photographs of the treated areas will be taken during each session.; Other Names: Active Microgalvanopuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Assessed by Dermatology Life Quality Index (DLQI)	Change in quality of life assessed using the Dermatology Life Quality Index (DLQI), Brazilian validated version (DLQI-BRA), developed by Finlay and Khan (1994). The DLQI is a 10-item questionnaire covering six domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Total scores range from 0 to 30, with higher scores indicating greater impairment in quality of life.	Baseline (before the first treatment session) and post-intervention (after 10 treatment sessions, approximately 10 weeks).
Impact of Stretch Marks on Quality of Life Assessed by Structured Interview	Change in stretch mark-specific quality of life assessed using the Structured Interview on the Impact of Stretch Marks on Quality of Life, developed for this study. The instrument consists of 9 Likert-scale questions (0-4 per item), evaluating the impact of stretch marks on self-image, self-esteem, and social behavior. Total scores range from 0 to 36, with higher scores indicating greater perceived negative impact.	Baseline (before the first treatment session) and post-intervention (after 10 treatment sessions, approximately 10 weeks).
Body Satisfaction	Change in participants' body satisfaction, assessed using the Body Shape Questionnaire (BSQ) developed by Cooper et al. (1987) and adapted for the Brazilian population by Di Pietro et al. (2009). The BSQ consists of 34 self-administered items rated on a 6-point scale (1 = never to 6 = always), with a total score of up to 204 points. Higher scores indicate greater body dissatisfaction. The questionnaire will be administered before the beginning of the intervention and after the last session to assess possible changes in body satisfaction levels following the treatment.	Baseline, pre- (before the first session) and post-intervention (after 10 treatment sessions, approximately 10 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Improvement of Striae Alba Assessed by Ordinal Photographic Scale (GAIS)	Clinical improvement of striae alba will be evaluated using standardized photographs obtained before the initiation of treatment (baseline) and after completion of the 10th treatment session. Images will be assessed by independent, blinded raters using a 5-point Global Aesthetic Improvement Scale (GAIS), ranging from 0 (no improvement or worsening) to 4 (marked improvement). Ratings will be based on comparison between baseline and post-intervention photographs. The distribution of ordinal improvement scores will be compared between intervention and control groups using appropriate statistical methods for ordinal data. Inter-rater reliability will be assessed.	Baseline (before the first treatment session) and after completion of the 10th treatment session (approximately 10 weeks).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variability Related to Skin Phototype	Assessment of whether the skin phototype influences treatment outcomes. The Fitzpatrick Skin Phototype Scale (1975) will be applied before the intervention to classify each participant's skin type (I-VI). After completion of the 10 treatment sessions, a comparative analysis will be performed between the photographic records (pre- and post-intervention) and each participant's skin phototype to identify whether specific skin tones demonstrate greater clinical improvement of striae alba.	Baseline (before the first treatment session) and post-intervention (after completion of 10 treatment sessions, approximately 10 weeks).
Pain Perception During Treatment Sessions	Evaluation of pain intensity experienced during each treatment session using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). Participants will be asked to report pain levels at the end of each of the 10 treatment sessions, specifying whether the pain occurred at the beginning, intermittently, throughout, or at the end of the session. The data will allow assessment of tolerance and pain variation across sessions.	During each of the 10 treatment sessions (weekly sessions for approximately 10 weeks).

Collaborators and Investigators

• Sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): November 1, 2025

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Microgalvanic current; Striae albae; Body satisfaction
• Additional Relevant MeSH Terms: Therapeutics; Punctures; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Percutaneous Collagen Induction
• Other Study ID Numbers: UFVJM-STRIAEALBAE-RCT-2024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be publicly shared due to privacy and ethical considerations related to clinical and photographic data. De-identified data underlying the results may be made available upon reasonable request to the corresponding author, subject to institutional approval and compliance with ethical and data protection regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No