PDF(Pubmed)
Abstract：
OBJECTIVE: Male and female pattern baldness, commonly known as androgenetic alopecia is the most common type of alopecia, often predetermined genetically, which generally affects the scalp and is characterized by progressive terminal hair loss, known as miniaturization. This study aimed to assess the safety and efficacy of Kerascalp hair serum, a unique combination of esculin, ximenynic acid, and lauric acid, extracted from natural sources in subjects with mild to moderate androgenetic alopecia.
METHODS: An open-label, single-arm clinical study was conducted on healthy males and females aged 18-60 years. Each subject applied the hair serum once daily for 90 days. The efficacy of hair serum was evaluated in terms of the following outcome variables: anagen and telogen ratio (A:T ratio), hair thickness, hair density, hair fall, and hair strength assessment. Subjects were assessed on day 0, day 30, day 60, day 90, and on follow-up day 120.
RESULTS: Thirty subjects completed all assessment visits. After using the hair serum for 90 days, statistically significant (p<0.0001) improvement was observed in A:T ratio, hair density, hair thickness, and hair strength; a statistically significant reduction (p<0.0001) in hair fall was also observed. Moreover, improvement in general appearance of hair (in terms of hair volume and density) and scalp (in terms of itchiness, redness, roughness, and dryness) was recorded through dermatological assessment at each treatment visit and at follow-up visit compared to baseline. No adverse event was recorded during the study period, and on follow-up.
CONCLUSIONS: The results of this clinical study suggest that a 90 days treatment with a phyto-ingredient-based Kerascalp hair serum is safe and effective in significantly improving A:T ratio, hair density, hair thickness, and hair strength, while reducing hair shedding. The improvement in the test parameters persists, even 30 days after stopping the usage of the serum.
METHODS: An open-label, single-arm clinical study was conducted on healthy males and females aged 18-60 years. Each subject applied the hair serum once daily for 90 days. The efficacy of hair serum was evaluated in terms of the following outcome variables: anagen and telogen ratio (A:T ratio), hair thickness, hair density, hair fall, and hair strength assessment. Subjects were assessed on day 0, day 30, day 60, day 90, and on follow-up day 120.
RESULTS: Thirty subjects completed all assessment visits. After using the hair serum for 90 days, statistically significant (p<0.0001) improvement was observed in A:T ratio, hair density, hair thickness, and hair strength; a statistically significant reduction (p<0.0001) in hair fall was also observed. Moreover, improvement in general appearance of hair (in terms of hair volume and density) and scalp (in terms of itchiness, redness, roughness, and dryness) was recorded through dermatological assessment at each treatment visit and at follow-up visit compared to baseline. No adverse event was recorded during the study period, and on follow-up.
CONCLUSIONS: The results of this clinical study suggest that a 90 days treatment with a phyto-ingredient-based Kerascalp hair serum is safe and effective in significantly improving A:T ratio, hair density, hair thickness, and hair strength, while reducing hair shedding. The improvement in the test parameters persists, even 30 days after stopping the usage of the serum.
摘要：
目标：男性和女性型秃发，通常被称为雄激素性脱发是最常见的脱发类型，通常是基因上预先确定的，通常影响头皮，其特征是进行性终末期脱发，被称为小型化。本研究旨在评估Kerascalp头发血清的安全性和有效性，esculin的独特组合,肟二酸，和月桂酸,从患有轻度至中度雄激素性脱发的受试者的天然来源中提取。
方法：开放标签，对18-60岁的健康男性和女性进行了单臂临床研究。每个受试者每天一次施用毛发精华液,持续90天。根据以下结果变量评估毛发血清的功效：生长期和静止期比率（A：T比率），头发厚度,头发密度,头发脱落,和头发强度评估。在第0天、第30天、第60天、第90天和随访第120天评估受试者。
结果：30名受试者完成了所有评估访视。使用头发精华液90天后，在A：T比率中观察到统计学上的显着（p<0.0001）改善，头发密度,头发厚度,和毛发强度;还观察到毛发脱落的统计学显著减少(p<0.0001)。此外，改善头发的一般外观（在头发体积和密度方面）和头皮（在瘙痒方面，发红,粗糙度,和干燥度）通过与基线相比的每次治疗访视和随访访视时的皮肤病学评估进行记录。在研究期间没有记录到不良事件，和后续行动。
结论：这项临床研究的结果表明，使用基于植物成分的Kerascalp头发血清进行90天治疗在显着改善A：T比率方面是安全有效的，头发密度,头发厚度,和头发强度，同时减少头发脱落。测试参数的改进仍然存在，甚至在停止使用血清30天后。
方法：开放标签，对18-60岁的健康男性和女性进行了单臂临床研究。每个受试者每天一次施用毛发精华液,持续90天。根据以下结果变量评估毛发血清的功效：生长期和静止期比率（A：T比率），头发厚度,头发密度,头发脱落,和头发强度评估。在第0天、第30天、第60天、第90天和随访第120天评估受试者。
结果：30名受试者完成了所有评估访视。使用头发精华液90天后，在A：T比率中观察到统计学上的显着（p<0.0001）改善，头发密度,头发厚度,和毛发强度;还观察到毛发脱落的统计学显著减少(p<0.0001)。此外，改善头发的一般外观（在头发体积和密度方面）和头皮（在瘙痒方面，发红,粗糙度,和干燥度）通过与基线相比的每次治疗访视和随访访视时的皮肤病学评估进行记录。在研究期间没有记录到不良事件，和后续行动。
结论：这项临床研究的结果表明，使用基于植物成分的Kerascalp头发血清进行90天治疗在显着改善A：T比率方面是安全有效的，头发密度,头发厚度,和头发强度，同时减少头发脱落。测试参数的改进仍然存在，甚至在停止使用血清30天后。
