White Stretch Marks (Striae Albae)
Conditions
Keywords
Microgalvanic current, Striae albae, Body satisfaction
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.
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.
Interventions
PROCEDUREControl 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.
PROCEDUREMicroneedling + 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.
Sponsors
Federal University of the Valleys of Jequitinhonha and Mucuri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Assessed by Dermatology Life Quality Index (DLQI) | Baseline (before the first treatment session) and post-intervention (after 10 treatment sessions, approximately 10 weeks). | 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. |
| Impact of Stretch Marks on Quality of Life Assessed by Structured Interview | Baseline (before the first treatment session) and post-intervention (after 10 treatment sessions, approximately 10 weeks). | 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. |
| Body Satisfaction | Baseline, pre- (before the first session) and post-intervention (after 10 treatment sessions, approximately 10 weeks). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
Countries
Brazil
Outcome results
None listed