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临床试验/NCT05775328
NCT05775328招募中不适用

Gender Affirmative Treatment of Hypertrichosis With Intense Pulsed Light - Effect on Hair Reduction and Quality of Life

Alexander Shayesteh1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
39
试验地点
1
主要终点
DLQI

研究概览

简要总结

The goal of this observational cohort study is to investigate the effect of intense pulsed light (IPL) for excessive hair in patients >18 years of age and in need of gender affirmative treatment, refered to the department of dermatology and venereology, Umeå University Hospital, Sweden. The main questions this study aims to answer are:

  • [To evaluate the effect of consecutive IPL treatments in women with hirsutism due to polycystic ovarial syndrome (PCOS), with or without anti-androgen treatment]
  • [To evaluate the effect of consecutive IPL treatments in individuals born as biologically men but in transition to become women, with or without hormonal treatment].

Patients will use self-assessed questionnaires evaluating:

  • Background characteristics and time spend on concealing, reducing and treating hypertrichosis at home.
  • Ferriman-Gallwey scale, regarding the intensity of their hypertrichosis.
  • Dermatology Life Quality Index (DLQI) for quality of life Patients will be recruited consecutively and assessed at each visit, at the clinic before the treatments, ranging from baseline to a minimum of 5 treatment sessions.Since this is an observational study, all patients are treated by others than the researchers according to the routines och the clonic and there will be no other groups to compare the patients with.

详细描述

Background Hypertrichosis is defined as excessive hair in men and women while the term hirsutism is used for women with increased hair count due to hormonal changes such as increased levels of androgens. Hypertrichosis can be focal och general and hereditary or acquired. In hereditary hypertrichosis, genes or in uterus exposure to certain medications have been suggested as causes for the condition. In acquired cases, the hypertrichosis is often triggered by hormonal changes due to different medical conditions.

Investigating the cause of hypertrichosis is done by examining the patient's medical history and a complete examination of the skin. An often-used tool, for severity assessment of hypertrichosis is Ferriman & Gallwey scale. This international scale is used both by clinicians and patients for both research and in clinical practice. The Ferriman & Gallwey scale investigate 9 parts of the body with each part visually described with increasing density of hair as 4 pictures ranging from 0 point (no hair) to 4 points (dense hair). According to Ferriman & Gallwey scale, a total of ≥8 points in white and black, ≥9-10 points for mediterranean, south american and middle eastern, and ≥2 points for east Asian women indicate hypertrichosis.

Hirsutism is a common feature in women with Polycystic Ovarian Syndrome. The increased density of hair becomes noticeable during puberty and affected women report a great negative impact from the condition on their quality of life. Signs of depression and anxiety are common in women with hirsutism, due to increased social isolation and remarks regarding the hair growth and its colour by their surroundings.

Individuals with gender dysphoria and in transition of gender reassignment from the biological male sex to female, are sometimes prescribed estrogen or anti-androgens to decrease male characteristics on their body. Feminizing hormone therapy for male-to-female gender dysphoria aim to minimize body and facial hair growth. In women with mild hirsutism, there is evidence that oral contraceptives and anti-androgen treatment could be beneficial against hair growth on the body. However, the effects of these medications together with other methods such light-based treatments as intense pulsed light or lasers have not been evaluated. Intense Pulsed Light (IPL) which transmit light as energy to become absorbed as heat in the hair follicle. Repeated treatments are necessary to obtain a significant reduction of hair and long-term effects of IPL in reducing hair varies. Theoretically, the combination of anti-androgens and estrogen together with IPL, should have a synergetic effect in hair reduction no matter the intention for hair reduction. Thus, the aim of this study is to evaluate the effects of IPL, in patient with hirsutism/hypertrichosis, with or without hormonal therapy, regarding hair reduction and potential impacts on quality of life.

Materials and methods Study design Observational Cohort study Patients Patients with hirsutism and gender dysphoria are medically treated and have their follow-ups by other specialities than dermatology. However, the laser clinic at the department of dermatology and venereology, Umeå university hospital receives referrals from other departments across northern Sweden for reducing body hair in these patients. Consecutive patients referred to the department of dermatology and venereology at Umeå University Hospital due to hypertrichosis will be assessed according to our inclusion and exclusion criteria.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 18 years of age and above
  • Diagnosis of PCOS obtained by a gynaecologist and hirsutism,
  • Diagnosis of gender dysphoria obtained after psychiatric evaluation,
  • ≥3 points in hair density according to Ferriman-Gallwey scale on a specific part of the body

排除标准

  • Language barrier causing problem in understanding questionnaires or not being able to give consent
  • Hair colours of white, orange or grey hair
  • Skin type 5 and above according to Fitzpatrick
  • Hereditary hypertrichosis

结局指标

主要结局

DLQI

时间窗: 2023-2025

The scale of Dermatology Life Quality Index. Anticipated reduction by 3 mean points between basle-line and the last treatment session.

次要结局

  • Complications(2023-2025)

研究者

发起方
Alexander Shayesteh
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Alexander Shayesteh

Assistant professor and senior consultant

Region Västerbotten

研究点 (1)

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