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临床试验/CTRI/2024/07/071507
CTRI/2024/07/071507尚未招募不适用

Effectiveness and safety of 308 nm excimer laser versus intralesional triamcinolone acetonide for the treatment of alopecia areata; A randomized control trial.

SRM Medical College Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Extent and density of regrowth by the SALT scoring system

研究概览

简要总结

Proceedure:

Patients  will be randomised in two groups A and B

  1. Group A : ILS ( triamcinolone acetonide 5 mg/ml ) given once in 4 weeks.
  2. Group B : 308 nm Excimer laser given twice a week

Group A

  • ILS ( triamcinolone acetonide 5 mg/ml ) given once in 4 weeks
  • Initial visit - evaluation and inclusion into study
  • Scalp will be adequately cleansed and degreased
  • It is injected intradermal as 0.1 ml per sq.cm of involved skin
  • Patients will be coming to the clinic at 4 weeks as per the schedule for subsequent injections at week 0,4,8 and 12 and follow up at week 16,20 and 24.
  • Follow up photographs taken at week 0,4,8,12,16,20 and 24.
  • Patient will be excluded from the study if he/ she delays for > 2 weeks

Group B

  • 308 nm Excimer laser given twice a week
  • Initial visit – evaluation, inclusion into study and  determination  of minimal erythema dose
  • Following visit, treatment is started at a sub MED dose
  • Subsequent irradiation dose  is increased  by 100 J/cm2 in next session till the endpoint is reached, which is 24 sittings or complete hair regrowth, whichever is earlier.

Assessment of hair regrowth

This takes into account extent and density of regrowth by the SALT scoring system. First note percent regrowth, then further categorise by:

  • A0 = no change or further loss
  • A1 = 1-24% regrowth
  • A2 = 25-49% regrowth
  • A3 = 50-74% regrowth
  • A4 = 75-99% regrowth
  • A5 = 100 % regrowth

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All patients of 18 years of age and above attending SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER dermatology OPD, diagnosed with alopecia areata.
  • Patients having 1-5 patches on the scalp.
  • Patients who have not received any hair related treatment in the past 3 months
  • Patients providing voluntary informed and written consent for the explained treatment modality to be performed.

排除标准

  • Other types of AA such as ophiasis, sisapho, totalis , universalis
  • Patients with single alopecic patch greater than 6x6 sq.cm Total area of all patches combined should not exceed 80 sq.cm
  • Pregnancy or breastfeeding
  • Infection
  • Other immunological disorders and endocrine diseases which causes hair loss
  • Photosensitive skin
  • Patients unwilling to continue cooperation in the trial
  • Progressive AA during the trial.

结局指标

主要结局

Extent and density of regrowth by the SALT scoring system

时间窗: Week 0, 4 ,8 ,12 , 16 20 and 24

次要结局

  • Visual Analogue Scale(Week 0, 4 ,8 ,12 , 16, 20 and 24)
  • Global Aesthetic Improvement Scale,(Patient satisfaction score)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Allam Priyanka Reddy

SRM Medical College and Research Centre

研究点 (1)

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