Methodology Validation: Correlating Adherent Scalp Flaking Score (ASFS) with Phototrichogram for Scalp Dandruff Evaluation in Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 1. ASFS: To assess the grade of scaling of the scalp by Dermatologist and Dermatologist-trained evaluator’s assessment, before and after hair wash.
研究概览
简要总结
This is an open label, single–arm, single-centre, prospective clinical study to validate the methodology of assessment of scalp flaking/dandruff using various techniques: Adherent Scalp Flaking Scoring by Dermatologist and Dermatologist-trained evaluator, Phototrichogram using CASLite Nova, and 60-second hair combing test for assessing the amount of non-adherent dandruff flakes. Considering the nature of the study, 12 female/male adult subjects with having mild to moderate scalp dandruff will be recruited/enrolled. The potential subjects will be screened as per the inclusion & exclusion criteria only after providing them with the Subject Information Sheet.
1. Visit 01 (Day 01): Screening, Enrolment, Evaluations
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 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 and 55 years (both inclusive).
- •Good general health as determined from recent medical history.
- •No previous history of adverse skin conditions, and not under any medication likely to interfere with the results.
排除标准
- •Non-willing subjects and subjects with a history of allergies or specific allergic reactions upon using dermatological/cosmetic products will not be included.
结局指标
主要结局
1. ASFS: To assess the grade of scaling of the scalp by Dermatologist and Dermatologist-trained evaluator’s assessment, before and after hair wash.
时间窗: On Day 01 for baseline, and post hair-wash on Day 01.
2. Scalp Condition: To assess the condition of the scalp via Phototrichogram using the instrument CASLite Nova, before and after hair wash.
时间窗: On Day 01 for baseline, and post hair-wash on Day 01.
次要结局
- 60-second hair combing test: To assess the amount of non-adherent scalp dandruff flakes using dermatological assessment, before and after hair wash(On Day 01 for baseline, and post hair-wash on Day 01.)
- Photographic Documentation: To assess the visible flakes/non-adherent scalp flakes fallen on the shoulders of the subjects, before and after hair wash(On Day 01 for baseline, and post hair-wash on Day 01.)
研究者
Maheshvari Patel
NovoBliss Research Private Limited