跳至主要内容
临床试验/NCT04893304
NCT04893304Unknown不适用

Study of the Effect of Fractional co2 Laser Versus Q Switched:NdYAG Laser in the Treatment of Acanthosis Nigricans

Cairo University0 个研究点目标入组 20 人开始时间: 2021年5月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
patient evaluation

研究概览

简要总结

This prospective randomized comparative split study will be conducted at the outpatient clinic, Dermatology department, Faculty of Medicine, Cairo University and will include 20 patients with acanthosis nigricans in otherwise healthy individuals which will be recruited and assessed for eligibility for inclusion according to the above criteria.

-Evaluation:

All patients will be subjected to:

Pre-operative preparation:

  • Informed written consent will be taken from every patient prior to the study.
  • Detailed history taking including onset, course, duration of the disease and occupation (sun-exposed or not), predisposing factors, history of keloid tendency, associated diseases and previous treatments.
  • Assessment of skin type, BMI, degree of AN, HbA1C, site of lesions in all patients and degree of improvement.
  • Photography: will evaluate the clinical response to treatment for each patient Photos will be taken before starting the study, before every session, and two weeks after the last session.
  • Melanin index (MI) will be measured using reflectance spectrophotometer in order to assess the degree of hyperpigmentation before starting the study and two weeks after the last session. Research Template 8 Final Version: April 2019
  • Acanthosis Nigricans Area and Severity Index (ANASI) score (Zaki et al., 2018) will be done for all patients before starting the study and two weeks after the last session.
  • Patient satisfaction score will be assessed before starting the study and two weeks after the last session.
  • Patient evaluation (clinical percentage of improvement).

Operation :

One side of the affected area will be randomly assigned to fractional CO2 laser every four weeks for three months. The other side will be assigned to Q-switched Nd:YAG laser every four weeks for three months.

Method of randomization:

Using closed envelopes containing cards with fractional CO2 Rt and fractional CO2 Lt and the patient will draw one of them blindly. The assessment will be done by blinded investigator. Post-operative: Patients will be instructed to avoid sun exposure for one week after the session and regular use of sun block in between sessions.

详细描述

This prospective randomized comparative split study will be conducted at the outpatient clinic, Dermatology department, Faculty of Medicine, Cairo University and will include 20 patients with acanthosis nigricans in otherwise healthy individuals which will be recruited and assessed for eligibility for inclusion according to the above criteria. -Evaluation:

All patients will be subjected to the following:

Pre-operative preparation:

Informed written consent will be taken from every patient prior to the study. Detailed history taking including onset, course, duration of the disease and occupation (sun-exposed or not), predisposing factors, history of keloid tendency, associated diseases and previous treatments.

Assessment of skin type, BMI, degree of AN, HbA1C, site of lesions in all patients and degree of improvement.

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
None

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

  • age more than 18 years old
  • both genders
  • skin type III to V
  • controlled diabetus

排除标准

  • pregnancy and lactation
  • active skin infections
  • endocrinal disorders

结局指标

主要结局

patient evaluation

时间窗: 3 months

Acanthosis nigricans area and severity index is scoring system used to assess patients before the session and after the session to assess finally the improvement

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

Aya Mohamed Fahim

Principale investigator

Cairo University

相似试验

Study of the Effect of Fractional co2 Laser Versus Q... | 临床试验