A PROSPECTIVE, SINGLE ARM, OPEN LABEL, SINGLE CENTRE CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF NIMSON AMLA OIL WITH VITAMIN C IN BENEFITTING THE HAIR GROWTH, REDUCING HAIRFALL, GREYING OF HAIR AND DANDRUFF
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- • Excellent reduction in the shedding range of the hair in the “60 Second Hair Comb testâ€
研究概览
简要总结
This study is a prospective, single arm, open label, single centre clinical study to evaluate the safety and efficacy of Nimson Amla oil with Vitamin C in benefitting the hair growth, reducing hairfall, greying of hair and dandruff.
Primary Objective
• Reduction in the shedding range of the hair in the “60 sec Hair comb test†from Visit 1 to the end of the study.
• Reduction in the “Adherent Scalp Flaking Score†from Visit 1 to the end of the study.
Secondary Objective
• Reasonable improvement in the “Subjective Hair Assessment Questionnaire†score from Visit 1 to the end of the study.
• Reasonable improvement the “Subject IP Feedback Questionnaire†score from Visit 2 to end of the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aged between 18 to 65 years.
- •Subjects who willing to give written informed consent and ready to comply with the protocol.
- •Subjects with active alopecia, premature greying of hair.
- •seborrheic dermatitis of the scalp – “Total ASFS Score ≥ 16
- •Subjects with a minimum hair length of 2 inches and willing to maintain the same minimum length, hair style until the end of the study.
排除标准
- •Subjects on topical treatment for alopecia, premature graying of the hair and seborrheic dermatitis for 8 weeks prior to enrollment.
- •Subject with other dermatological disorders of the scalp that might interfere with the study evaluation.
- •Subjects with significant scalp scarring.
- •Subjects who have anemia or iron deficiency.
- •Subjects who have previously undergone hair transplantation procedures.
- •History of systemic or cutaneous malignancy or evidence of immunocompromised state.
- •Subjects with history of skin allergy.
- •Subjects on systemic steroids for more than 14 days within 2 months prior to enrollment.
- •Female subjects who are reported pregnant/planning a pregnancy or lactating.
- •Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrollment.
- •Subjects, who in the opinion of the Investigator or the Expert Dermatologist are not eligible for enrollment in the study.
结局指标
主要结局
• Excellent reduction in the shedding range of the hair in the “60 Second Hair Comb testâ€
时间窗: Day 42
from visit 1 to the end of the study.
时间窗: Day 42
• Excellent reduction in the flaking severity in the “Adherent Scalp Flaking Score†from visit 1 to the end of the study.
时间窗: Day 42
次要结局
- • Reasonable improvement in the “Subjective Hair Assessment Questionnaire†score from visit 1 to end of the study.(• Reasonable improvement the “Subject IP Feedback Questionnaire†score from Visit 2 to end of study.)