An Open-Label Exploratory Study on the Efficacy of a Multi-Ingredient Natural Topical Formulation STRETCH MARKS B GONE for the Management of Stretch Marks (Striae Distensae)
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Dermesse Raw and Naturals Private Limited., India
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Mean change from baseline, Week 2 and Week 4 in photo
概览
简要总结
This open-label exploratory study will evaluate the efficacy and safety of a natural topical formulation, STRETCH MARKS B GONE, for improving stretch marks (striae distensae).
Inclusion and Exclusion Criteria:
Twenty-five adults (20 females, 5 males) aged 18–45 years with visible stretch marks on the abdomen, hips, thighs, knees, or shoulders for at least 3 months to 1 year due to weight changes or postpartum effects will be enrolled. Participants will apply the product twice daily for 4 weeks.
The primary objective is to assess changes in stretch-mark appearance using photographic and morphometric analysis.
Secondary objectives include evaluation of skin hydration, elasticity, and patient-reported outcomes on dryness, itching, and comfort. Assessments will be performed at baseline, Week 2, and Week 4 to confirm visible improvement and product safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults 18–45 years.
- •Visible stretch marks (striae rubra or alba) on belly/hips/thighs/knees and shoulders, present Greater than or equal to 3 months to 1 years due to change in the body weight, Post Partum Changes.
- •Willing to refrain from other topical treatments/procedures on test areas during the study.
- •Able to comply and sign informed consent.
排除标准
- •Pregnant or breastfeeding.
- •Known allergy to any ingredient of test product.
- •Recent Greater than or equal to 3 topical retinoid, steroid, or procedural treatment on target areas.
- •Active dermatitis or infection in test area.
- •Participation in another clinical study within 30 days.
结局指标
主要结局
Mean change from baseline, Week 2 and Week 4 in photo
时间窗: Baseline (Day 0), Visit 2 (week 2), Visit 3 (28 days)
graded Visual Improvement Scale (VIS) and or percent change
时间窗: Baseline (Day 0), Visit 2 (week 2), Visit 3 (28 days)
in stretch-marks. (For those who give consent)
时间窗: Baseline (Day 0), Visit 2 (week 2), Visit 3 (28 days)
次要结局
- 1. Skin texture: Mean percentage improvement - baseline and Week 4 (target: approx 25 percent improvement). Report mean ± SD and CI.((instrument plus Self-assessment))
研究者
Dr Roshany
DK Elite Health Care Centre