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临床试验/NCT05803070
NCT05803070尚未招募不适用

Topical Cetirizine Versus Topical Betamethasone in Treatment of Localized Alopecia Areata

Assiut University0 个研究点目标入组 59 人开始时间: 2023年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
59
主要终点
Compare topical cetirizine and betamethasone valerate in treatment of alopecia areata

研究概览

简要总结

Evaluate and compare the efficacy and safety of topical cetirizine 1%, versus topical betamethasone valerate 0.1% in the treatment of localized alopecia areata.

详细描述

Alopecia areata (AA) is one of the commonest autoimmune non-cicatricial hair loss that affects different parts of hair-bearing areas of the body . Nearly 2% of the population at some stage of their life may be affected by alopecia areata while the prevalence of alopecia areata was reported to be between 0.1% to 0.2%. Alopecia areata can occur at any age, although it starts in the first three decades of life in most patients, and both sexes are equally affected. It can present clinically as a well-defined patch of hair loss, diffuse hair loss, reticulate hair loss, ophiasis, ophiasis inversus, alopecia totalis (complete loss of scalp hair), or alopecia universalis (hair loss of all over the body).

Many treatment options including topical, systemic, injectable and laser modalities have been used for the treatment of AA . Among the various treatment options for alopecia areata, topical corticosteroids as betamethasone valerate are considered as standard therapy.

There have been reports on the efficacy/adjunctive role of systemic antihistamines in alopecia areata. Moreover, fexofenadine was found to enhance hair regrowth in two cases of extensive resistant alopecia areata.

Cetirizine hydrochloride belongs to a family of medicines called antihistamines which has varied medical uses and is commonly used to relieve allergy symptoms such as watery eyes, runny nose, sneezing, hives, and itching. In addition, it has been demonstrated that cetirizine inhibits release of prostaglandin D2 and stimulates the release of prostaglandin E2 .

Topical cetirizine was used with good results and with no notable side effects for the treatment of androgenic alopecia. Because of this evidence and the absence of hormonal influence, cetirizine was considered suitable for this kind of hair loss .

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
12 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants of both sex with age ≥ 12 years.
  • Localized alopecia areata: <50% affection of the scalp surface.
  • Stable disease (no new patches or increase in size for at least 2 weeks)

排除标准

  • Uncertain diagnosis.
  • Age < 12 years.
  • Severe forms of alopecia (extensive alopecia; > 50% of scalp surface), ophiasis type, alopecia totalis or alopecia universalis.
  • Alopecia Areata outside the scalp.
  • Patients who have received topical treatment for alopecia areata in the past month.
  • Patients who have received systemic treatment for alopecia areata in the past 2 months.
  • Any associated skin or hair disorders.
  • Any associated medical condition requiring oral corticosteroids, immunosuppressive or light therapy.
  • Presence of any systemic autoimmune disease.
  • Pregnant and lactating women
  • Unrealistic expectations.

研究组 & 干预措施

A

patients with alopecia areata who will be treated with topical cetirizine 1%

干预措施: Topical Cetirizine 1 % (Drug)

B

patients with alopecia areata who will be treated with topical betamethasone valerate 0.1%

干预措施: Topical betamethasone valerate 0.1% (Drug)

结局指标

主要结局

Compare topical cetirizine and betamethasone valerate in treatment of alopecia areata

时间窗: baseline

compare the healing rate

Clinical evaluation by SALT score

时间窗: baseline

an ideal objective method of follow-up and good evaluation of any therapeutic option

Clinical evaluation by patient's satisfaction level

时间窗: baseline

Asking the patients about their satisfaction towards treatment using a five-point scale (-1: condition worsened, 0: not satisfied, 1: poorly satisfied, 2: moderately satisfied, 3: very satisfied)

Clinical evaluation by photographic evaluation

时间窗: baseline

The photographs and response to treatment will be evaluated objectively by two-blinded dermatologists using a five-point semiquantitative score (regrowth scale) defined as follows: 0 score (regrowth \<10%), 1 score (regrowth 11-25%), 2 score (regrowth 26-50%), 3 score (regrowth 51-75%), 4 score (≥ 75)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariam Esam Fathy

doctor

Assiut University

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