A prospective, open label, one arm study to evaluate the safety and efficacy of LAFZ ETHNIC Tea Tree Oil & Lemon Refreshing Anti-Dandruff Herbal Shampoo in reduction of mild to moderate dandruff in healthy male or female volunteers
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- •Reduction of dandruff through Adherent Scalp Flaking Score (ASFS) from baseline to end of the study.
研究概览
简要总结
After obtaining the Ethics committee approval subjects will be asked to visit the site. Informed consent will be administered to study volunteers, and after obtaining their consent in writing, the subjects will be asked about their medical history and the Investigator or his/her designee will conduct a physical examination. Demographics and vital signs will be recorded. Subjects shall avoid using their own hair care products for at least one week before commencement of this study. Once the subjects are found eligible, they will be provided with IP and advised to use twice a week. They also will be advised to take the efficacy assessments like Videoscopy, Adherent Scalp Flaking Score and asked to fill the feedback questionnaire. The results obtained will be analyzed at the end of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Healthy Indian male/female volunteer aged between 18-45 years (both inclusive) • Willing to give Informed Consent • Subjects diagnosed with of mild to moderate dandruff, assessed by mean total Adherent Scalp Flaking Score (ASFS) of 8 zones in the scalp.
- •â€¢Willing to complete the study assessments/questionnaires.
- •â€¢ Willing to avoid usage of his/her own hair care products in controlling hair fall and dandruff for at least one week before the commencement and during this study.
排除标准
- •â€¢ Pregnancy or breast feeding.
- •â€¢ Patients diagnosed with severe dandruff, Itching, flaking, pruritis and visible inflammation over face, retro auricular area, and the upper chest.
- •â€¢ Patients with inflammatory or infective scalp conditions.
- •â€¢Patients with history of hypersensitivity to hair products • Patients with mild to severe anaphylaxis reaction.
- •â€¢ Patients with pre existing severe systemic disease necessitating long term medication.
- •â€¢ Evidence of significant uncontrolled co morbid disease which in the investigators opinion would jeopardize patient participation.
- •â€¢ History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ.
- •â€¢ Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month.
结局指标
主要结局
•Reduction of dandruff through Adherent Scalp Flaking Score (ASFS) from baseline to end of the study.
时间窗: Day 0 to Day 30
次要结局
- •Consumer feedback will be obtained via a set of subjective questionnaires to evaluate the response towards the product.(Day 0 to Day 30)