Clinical Method Development and Standardization Plan for Measuring Hair Growth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- To establish a standardized methodology that integrates various parameters comprehensively assess and evaluate hair growth and scalp health.
研究概览
简要总结
The objective of this study is to establish a standardized methodology that integrates various parameters to comprehensively assess and evaluate hair growth and scalp health.
详细描述
A total of 25 participants, consisting of 13 males and 12 females who have complaints of androgenetic alopecia (AGA) will be enrolled.
This research seeks to develop and implement a robust and standardized approach that incorporates a diverse range of parameters. These parameters include:
- Measurement of hair regrowth from AGA-affected area.
- Number of new hairs from the AGA-affected area and tattoo area.
- Evaluation of hair strength through tensile testing.
- Assessment of hair length
- Global picture of head crown
- Quantitative analysis of scalp keratin levels.
- Visual documentation and quantitative scoring of baldness using the Norwood-Hamilton and Ludwig scales and its inter-variability.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
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.
- •Patient having androgenic alopecia condition with grade of 1 to 3 (Dermatological assessment)
排除标准
- •Recent hair transplantation or other surgical interventions on the scalp within the past year.
- •Pregnant or breastfeeding women will be excluded due to potential hormonal influences on hair growth.
- •History of cancer treatment involving chemotherapy or radiotherapy to the scalp.
- •Presence of significant dermatological conditions affecting the scalp other than androgenetic alopecia (e.g., psoriasis, severe seborrheic dermatitis).
- •History of major systemic diseases (e.g., uncontrolled diabetes, severe cardiovascular diseases, autoimmune disorders).
- •Any other condition which could warrant exclusion from the study, as per the dermatologist/investigator's discretion.
结局指标
主要结局
To establish a standardized methodology that integrates various parameters comprehensively assess and evaluate hair growth and scalp health.
时间窗: 0n Day 1
To establish a standardized methodology for measurement of hair regrowth from AGA-affected area (bald scalp) and tattoo area.
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Evaluated using the standardized area 30 cm from nose tip followed by the CASLite Nova.
To establish a standardized methodology for evaluating number of new hairs from the AGA-affected area (bald scalp) and tattoo area.
时间窗: 0n Day 1
Evaluated using the standardized area 30 cm from nose tip followed by the CASLite Nova.
To establish a standardized methodology for evaluation of hair strength through tensile testing
时间窗: 0n Day 1
Evaluated using TESTRONIX Instrument.
To establish a standardized methodology for assessment of hair length
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Evaluated using the standardized area 15 cm away from the tip of the nose towards scalp vertex.
To establish a standardized methodology for assessment of Global picture of head crown
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Evaluated digital photographs of the alopecia at 0° Angle, 45° Angle, 90° Angle.
To establish a standardized methodology for assessment of quantitative scalp keratin assessment.
时间窗: 0n Day 1
Evaluated using CASLite Nova Instrument
To establish a standardized methodology for assessment of quantitative hair keratin assessment.
时间窗: 0n Day 1
Evaluated using Bradford Assay.
To establish a standardized methodology for quantitative scoring of baldness using the Norwood-Hamilton and Ludwig scales and its inter-observer variability.
时间窗: 0n Day 1
Evaluated using certified Dermatologist where type I = Minimal recession of the hairline and type Va indicates Most advanced degree of alopecia
次要结局
未报告次要终点