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

NCT07455669 | Completed

• 1 other identifier: UFVJM-STRIAEALBAE-RCT-2024-01
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

White Stretch Marks (Striae Albae)

Keywords

Microgalvanic current; Striae albae; Body satisfaction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Clinical Improvement of Striae Alba Assessed by Ordinal Photographic Scale (GAIS)

  Baseline (before the first treatment session) and after completion of the 10th treatment session (approximately 10 weeks).

Other Outcomes (2)

• Variability Related to Skin Phototype

  Baseline (before the first treatment session) and post-intervention (after completion of 10 treatment sessions, approximately 10 weeks).

• Pain Perception During Treatment Sessions

  During each of the 10 treatment sessions (weekly sessions for approximately 10 weeks).

Study Arms (2)

Sham Microgalvanic Current

PLACEBO COMPARATOR

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

Microgalvanic Current

EXPERIMENTAL

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

Interventions

Control group placebo PROCEDURE

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.

Also known as: Microneedling (Device Off)

Sham Microgalvanic Current

Microneedling + Microgalvanic Current PROCEDURE

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.

Also known as: Active Microgalvanopuncture

Microgalvanic Current

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: Participants must be biologically female and self-identify as women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Federal University of Jequitinhonha and Mucuri Valleys

Diamantina, Minas Gerais, 39100000, Brazil

Location

MeSH Terms

Interventions

Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a parallel assignment randomized clinical trial design. Participants are randomly assigned to one of two groups: the control group, receiving only the microneedling effect with the device turned off, and the intervention group, receiving both microneedling and microgalvanic current effects. The two groups are treated simultaneously over 10 weekly sessions of approximately 50 minutes each. Pre- and post-intervention assessments will be conducted to evaluate 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 to monitor changes.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: March 6, 2026
• Study Start: April 8, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)