Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:34 PM
Study NCT ID:
NCT07455669
Status:
COMPLETED
Last Update Posted:
2026-03-06
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Microgalvanic Current on Body Satisfaction and Quality of Life in Women With Striae Alba
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097244', 'term': 'Percutaneous Collagen Induction'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Variability Related to Skin Phototype', 'timeFrame': 'Baseline (before the first treatment session) and post-intervention (after completion of 10 treatment sessions, approximately 10 weeks).', 'description': "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."}, {'measure': 'Pain Perception During Treatment Sessions', 'timeFrame': 'During each of the 10 treatment sessions (weekly sessions for approximately 10 weeks).', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Quality of Life Assessed by Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Baseline (before the first treatment session) and post-intervention (after 10 treatment sessions, approximately 10 weeks).', 'description': '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.'}, {'measure': 'Impact of Stretch Marks on Quality of Life Assessed by Structured Interview', 'timeFrame': 'Baseline (before the first treatment session) and post-intervention (after 10 treatment sessions, approximately 10 weeks).', 'description': '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.'}, {'measure': 'Body Satisfaction', 'timeFrame': 'Baseline, pre- (before the first session) and post-intervention (after 10 treatment sessions, approximately 10 weeks).', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Clinical Improvement of Striae Alba Assessed by Ordinal Photographic Scale (GAIS)', 'timeFrame': 'Baseline (before the first treatment session) and after completion of the 10th treatment session (approximately 10 weeks).', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microgalvanic current', 'Striae albae', 'Body satisfaction'], 'conditions': ['White Stretch Marks (Striae Albae)']}, 'descriptionModule': {'briefSummary': '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).\n\nThe 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.\n\nAll 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.', 'detailedDescription': '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.\n\nStandardized 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.\n\nAll 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'Participants must be biologically female and self-identify as women.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Biologically female individuals\n* Age between 20 and 35 years\n* Presence of white stretch marks (striae albae)\n* Availability to participate for the entire duration of the study\n* Properly and completely signed Informed Consent Form, Image Use Agreement and all study questionnaires\n\nExclusion Criteria:\n\n* Cardiac arrhythmia or pacemaker\n* Hemophilia\n* Uncontrolled arterial hypertension\n* Diabetes mellitus\n* Predisposition to keloid formation\n* Hypersensitivity to electrical current stimulation\n* Pregnancy\n* Any abnormalities or diseases (e.g., Cushing's syndrome) that impair skin healing\n* Open wounds\n* Current or recent use of corticosteroids, steroids or anti-inflammatory medications"}, 'identificationModule': {'nctId': 'NCT07455669', 'briefTitle': 'Effects of Microgalvanic Current on Body Satisfaction and Quality of Life in Women With Striae Alba', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of the Valleys of Jequitinhonha and Mucuri'}, 'officialTitle': 'Effects of Microgalvanic Current as an Adjunct Intervention on Body Satisfaction and Quality of Life in Women With Striae Alba: a Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'UFVJM-STRIAEALBAE-RCT-2024-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sham Microgalvanic Current', 'description': '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.', 'interventionNames': ['Procedure: Control group placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Microgalvanic Current', 'description': '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.', 'interventionNames': ['Procedure: Microneedling + Microgalvanic Current']}], 'interventions': [{'name': 'Control group placebo', 'type': 'PROCEDURE', 'otherNames': ['Microneedling (Device Off)'], 'description': '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.', 'armGroupLabels': ['Sham Microgalvanic Current']}, {'name': 'Microneedling + Microgalvanic Current', 'type': 'PROCEDURE', 'otherNames': ['Active Microgalvanopuncture'], 'description': '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.', 'armGroupLabels': ['Microgalvanic Current']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39100000', 'city': 'Diamantina', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Federal University of Jequitinhonha and Mucuri Valleys', 'geoPoint': {'lat': -18.24692, 'lon': -43.60345}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of the Valleys of Jequitinhonha and Mucuri', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}