White Stretch Marks (Striae Albae)NCT07455669
Effects of Microgalvanic Current on Body Satisfaction and Quality of Life in Women With Striae Alba
A study testing Microneedling + Microgalvanic Current in people with White Stretch Marks (Striae Albae), run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- White Stretch Marks (Striae Albae)
- What is being tested?
- Microneedling + Microgalvanic Current
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Apr 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Cardiac arrhythmia or pacemaker
- Hemophilia
- Uncontrolled arterial hypertension
- Diabetes mellitus
- Predisposition to keloid formation
- Hypersensitivity to electrical current stimulation
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Jequitinhonha and Mucuri Valleys
Diamantina, Minas Gerais, 39100000
About this study
Official title: 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.
Read the 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)
- Being tested
- Control group placebo, Microneedling + Microgalvanic Current
- Keywords
- Microgalvanic current, Striae albae, Body satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group placeboProcedure or surgery
Also called Microneedling (Device Off)
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.
Microneedling + Microgalvanic CurrentProcedure or surgery
Also called Active Microgalvanopuncture
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Microneedling + Microgalvanic Current |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: Baseline (before the first treatment session) and after completion of the 10th treatment session (approximately 10 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start8 Apr 2024
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Stretch Marks (Striae Albae)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and Mucuri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455669
- Sponsor's protocol ID
- UFVJM-STRIAEALBAE-RCT-2024-01
- Status last verified
- Mar 2026
- First submitted
- 5 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Microgalvanic Current as an Adjunct Intervention on Body Satisfaction and Quality of Life in Women With Striae Alba: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07455669
- Acronym / sponsor ID
- UFVJM-STRIAEALBAE-RCT-2024-01
- Conditions
- White Stretch Marks (Striae Albae)
- Keywords
- Microgalvanic current, Striae albae, Body satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and MucuriUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sham Microgalvanic Current | Placebo comparator | Procedure: Control group placeboParticipants 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. |
| Microgalvanic Current | Experimental | Procedure: Microneedling + Microgalvanic CurrentParticipants 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Cardiac arrhythmia or pacemaker
- Hemophilia
- Uncontrolled arterial hypertension
- Diabetes mellitus
- Predisposition to keloid formation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control group placeboAlso: Microneedling (Device Off)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 or surgery | Sham Microgalvanic Current |
| Microneedling + Microgalvanic CurrentAlso: Active MicrogalvanopunctureParticipants 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. | Procedure or surgery | Microgalvanic Current |
Primary outcome
Quality of Life Assessed by Dermatology Life Quality Index (DLQI)
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Clinical Improvement of Striae Alba Assessed by Ordinal Photographic Scale (GAIS)
Time frame: Baseline (before the first treatment session) and after completion of the 10th treatment session (approximately 10 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling + Microgalvanic Current in people with White Stretch Marks (Striae Albae), run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Assessed by Dermatology Life Quality Index (DLQI) (time frame: Baseline (before the first treatment session) and post-intervention (after 10 treatment sessions, approximately 10 weeks).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.