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临床试验/CTRI/2017/08/009254
CTRI/2017/08/009254招募中不适用

Quantification of levels of biotin and copper in serum and hair samples of women with chronic telogen effluvium

Indian Association of Dermatologists Venereologists and Leprologists1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2016年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
172
试验地点
1
主要终点
Levels of biotin and copper in serum and hair samples

研究概览

简要总结

Women presenting with diffuse hair loss is a commonchallenging problem encountered by the dermatologists. The most common cause istelogen effluvium which is often triggered by endocrine, nutritional orautoimmune etiologies. However, in chronic telogen effluvium (CTE) wherein thehair loss lasts for more than 6 months, the precipitant is often not identifiedand it is often a routine practice to supplement these patients with biotin andmicronutrients like zinc, copper, iron and selenium. The rationale ofsupplementation is based on the observation that alopecia is one of many consequencesassociated with biotin, copper and zinc deficiencies. However till date thereare no evidences to support deficiency of biotin or these micronutrients andthere are no clinical trials to demonstrate their supplementation to beeffective in hair loss (CTE).  This isalso the case with iron deficiency, which is often believed to be a cause ofhair loss (CTE) , wherein the literature reports are inconsistent regardingrole of iron supplementation. Some nutritional supplements are, however,approved as drugs not requiring prescriptions and not reimbursable by healthcare insurers. In addition, it has also been reported that excessive intakes ofnutritional supplements may actually cause hair loss and are not recommended inthe absence of a proven deficiency.

Hence, we propose to study the levels of biotin andcopper in serum and hair of women with chronic telogen effluvium in comparisonto those without hair loss. If a deficiency of biotin and copper is observed inthose with hair loss, we would like to estimate the cut off levels at whichhair loss occurs.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • •Cases: •Consecutive consenting women aged 18-45 years presenting to the dermatology OPD with diffuse hair loss lasting for more than 6 months diagnosed as chronic telogen effluvium based on modified hair wash test and trichoscopy Controls: •Consenting women with no hair loss attending the dermatology OPD.

排除标准

  • •Cases and Controls: •Lactating women •Post-menopausal women •Prescription drugs known to affect the hair growth within the last six months •Known systemic causes of hair loss (symptomatic anemia with Hb < 10gm/dl, overt hypo or hyperthyroidism on treatment, known diabetics and hypertensives on treatment, hepatic and renal diseases, connective tissue diseases, malignancies, tuberculosis) •Chronic drug intake •Inflammatory dermatoses involving scalp and hair – psoriasis, lichen planus, discoid lupus erythematosus •History of hair dye application and cosmetic hair treatments like straightening, ironing, perming in the last 6 months.

结局指标

主要结局

Levels of biotin and copper in serum and hair samples

时间窗: at the end of the stu | one year.

次要结局

未报告次要终点

研究者

申办方类型
Other [Indian Association of Dermatologists Venereologists and Leprologists]

研究点 (1)

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