Effects of Microgalvanic Current as an Adjunct Intervention on Body Satisfaction and Quality of Life in Women With Striae Alba: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Quality of Life Assessed by Dermatology Life Quality Index (DLQI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Sham Microgalvanic Current
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.
干预措施: Control group placebo (Procedure)
Microgalvanic Current
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.
干预措施: Microneedling + Microgalvanic Current (Procedure)
结局指标
主要结局
Quality of Life Assessed by Dermatology Life Quality Index (DLQI)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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).)