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临床试验/CTRI/2024/04/065823
CTRI/2024/04/065823尚未招募3 期

comparative efficacy of electrosurgery and trichloroacetic acid application in xanthelasma palpebrarum

government medical college and hospital1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年5月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
21
试验地点
1
主要终点
1. To compare the clinical efficacy of electrosurgery and trichloroacetic acid in the treatment of xanthelasma palpebrarum.

研究概览

简要总结

A prospective clinical trial comparing the efficacy of trichloroacetic acid and electrosurgery  in the treatment of xanthelasma palpebrarum.All patients of xanthelasma palpebrarum attending the dermatology outpatient department at GMCH-32, Chandigarh shall be recruited in the study.  The patients shall be included keeping in view the inclusion and exclusion criteria. The clinical diagnosis of xanthelasma Palpebrarum shall be made by the two independent dermatologist. 21 patients conforming to the above-mentioned shall be selected for the study.Patient of xanthelasma palpebrarum shall be selected with the help of random table method.21 patients shall be recruited. For each recruited patient, electrosurgery will be done on one eye and 100% trichloroacetic acid application shall be done on the other eye. For baseline assessment, photographs along with measurement of the lesions along two dimensions shall be  noted.Clinical photographs will be taken and labelled by specific numbers for each patient before starting the treatment and at each follow up visit. The final outcome shall be scored on a 0-4 point scale: 0 – no improvement

1 – moderate improvement ( up to 25% clearing of the lesion)

2 – satisfactorily result (25-50% clearing of the lesion)

3 – good result (50-75% clearing of the lesion)

4 – excellent result (>75% clearing of the lesion)

Final assessment of the patients shall be done at the end of 3 months. Any scars, hyperpigmentation, hypopigmentation, recurrences shall be documented. Assessment of improvement for efficacy of therapy will be done by serial photographs and measurement of the lesion size along two dimensions at each visit (0, 3, 6, 9 and 12 weeks) and 3 months after the last session for final follow up. Parameters studied shall include age, sex, duration of the disease, number of lesions, clinical morphology of lesions, associated medical conditions, other associated xanthomas.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • •All patients of xanthelasma palpebrarum of 18-50 years of age with a clinical diagnosis of xanthelasma palpebrarum attending the dermatology outpatient department at GMCH-32, Chandigarh shall be recruited in the study.
  • •The patients shall be included keeping in view the inclusion and exclusion criteria.
  • •The clinical diagnosis of xanthelasma Palpebrarum shall be made by the two independent dermatologists.
  • •21 patients conforming to the above-mentioned shall be selected for the study.

排除标准

  • •EXCLUSION CRITERIA:
  • •Patients with known allergy to lignocaine
  • •Patient on anticoagulants/bleeding tendencies/ with known cardiac illness/pacemakers.
  • •Patients with atopy/periorbital dermatitis/ any active disease around eyes
  • •Patients with known diabetes/ poor glycaemic control/on immunosuppression.

结局指标

主要结局

1. To compare the clinical efficacy of electrosurgery and trichloroacetic acid in the treatment of xanthelasma palpebrarum.

时间窗: 18 months

次要结局

  • To compare the adverse effects of these modalities of treatment in xanthelasma palpebrarum.

研究者

发起方
government medical college and hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Madhurpreet kaur

Government medical college and hospital

研究点 (1)

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