A clinical study to evaluate the safety and efficacy of the test product in improving scalp health over 4 weeks in comparison to baseline.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1) Improvement of scalp health/condition and significant reduction of the total dandruff score, Non-Adherent and Adherent flakes score evaluated by Visual assessment.
研究概览
简要总结
This 4-week monocentric clinical study aims to evaluate the effectiveness of three test products in improving scalp health. Ninety male participants, aged 18-45, will be divided across three test groups. During Visit 1 (screening), subjects will undergo acclimatization, and baseline assessments related to scalp health along with microbiome sampling and they will be instructed about the use of the test product. In Visit 2 (Week 2), product compliance will be checked, and similar assessments will be repeated. During Visit 3 (Week 4), final evaluations will be conducted, and the test products, diaries, and exit form will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male subjects in general good health with scalp conditions (Dry, Itchy, Irritated, Redness, Flaking) 2) Subjects in the age group 18-45 years (both ages inclusive).
- •Subjects with moderate flakes.
- •Subjects willing to give written informed consent and willing to abide by and comply with the study protocol.
- •Subjects willing to refrain from using any other product that can impact scalp health.
排除标准
- •Subjects having any active scalp disease which may interfere with the study based on the dermatologist’s discretion.
- •Subjects who have taken chemotherapy for cancer in the 6 months prior to the start of the study.
- •Subjects who have undergone hair transplants.
- •A known history or present condition of allergic response/hypersensitivity to any hair or pharmaceutical products.
- •Subjects on oral medications like topical or systemic corticosteroids, anti-fungal, or antibiotics, or any prolonged use of non-steroidal anti-inflammatory, or anti-histaminic within 2 weeks prior to the study, undergoing any chemical hair salon treatment-straightening / perming/color/henna which will compromise the study.
- •Subjects participating in other similar trials within the last 2 weeks.
- •Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, thyroid, hepatitis, severe anemia, serious disorder of the heart and respiratory apparatus or any other serious medical illness 8) Employees of MSCR or the sponsor.
结局指标
主要结局
1) Improvement of scalp health/condition and significant reduction of the total dandruff score, Non-Adherent and Adherent flakes score evaluated by Visual assessment.
时间窗: Baseline, week 2 and week 4
2) Reduction in oiliness and Improved scalp hydration by non-invasive instrumental assessment.
时间窗: Baseline, week 2 and week 4
3) Efficacy of the test product in reducing flakes using the Visible Flake Assessment.
时间窗: Baseline, week 2 and week 4
4) Change of microbiome of the scalp by product usage at week 4.
时间窗: Baseline, week 2 and week 4
5) Improved scalp condition by microscopic imaging.
时间窗: Baseline, week 2 and week 4
次要结局
- 1) Improved scalp health by Subject self-assessment.(Baseline, week 2 and week 4)
研究者
Dr Sharad Nadiga
MS Clinical research