跳至主要内容
临床试验/NCT02467101
NCT02467101Unknown不适用

Prospective Double-blind, Placebo Controlled Study to Assess the Efficacy of Intralesional Corticoid on the Treatment of Frontal Fibrosing Alopecia

Rubina Alves2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
2
主要终点
Phototricogram of two areas of the scalp

研究概览

简要总结

The purpose of this study is to determine the efficacy of treatment with intralesional injection of corticosteroids on the treatment of Frontal Fibrosing Alopecia (compared with placebo), between three months, six months and baseline.

详细描述

Frontal fibrosing alopecia (FFA) is a primary lymphocytic cicatricial alopecia, that was first described in postmenopausal women, by Kossard in 1994. Since then, FFA has also been reported in premenopausal women and rarely in men.

The exact cause of FFA is unknown. One possible reason can be the disturbed immune response to some component of the scalp hair follicles, however, whether or not the hair loss is caused by hormonal fluctuations is under question. Some authors, consider that FFA is a variant of liquen planopilaris (LPP). Whether FFA is truly an LPP variant or is a distinct entity with shared clinical features remains to be determined. FFA was also diagnosed in family members (mother and daughter) suggesting a possible genetic contribution.

Clinically, it is characterized by progressive frontal and temporoparietal recession of the hairline due to inflammatory destruction of hair follicles. Hair loss occurs in a band-like distribution and the depth of recession can be from 0,5-8 cm. Often, a small number of isolated hairs are spared within the band of alopecia.

Loss of eyebrows (partial or complete) is a finding in FFA and in some cases, can precede the hairline recession. The affected skin is atrophic, shiny, and often lighter than the chronically sun-exposed forehead skin.

The diagnosis of FFA is usually made on the basis of clinical findings, and laboratory tests are rarely required. Dermoscopy, a noninvasive tool can help for the diagnosis of FFA; The dermoscopic features of FFA are: Absence of follicular openings, perifollicular scale, and a feeble perifollicular erythema. Perifollicular erythema at the receding hairline may be a sign of active disease.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with the diagnosis of Frontal Fibrosing Alopecia

排除标准

  • Pregnancy
  • Patient unable to accomplishing all fases of treatment

结局指标

主要结局

Phototricogram of two areas of the scalp

时间窗: 6 months

Measuring hair count (number of hairs/0.65 cm2) by comparison with 6 months and baseline

次要结局

  • Global photographs of the scalp(6 months)

研究者

发起方
Rubina Alves
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rubina Alves

Specialist Dermatology, M.D.

Universitat Internacional de Catalunya

研究点 (2)

Loading locations...

相似试验