NCT07455669

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• White Stretch Marks (Striae Albae)

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-04-08
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: Brazil