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临床试验/CTRI/2023/07/054989
CTRI/2023/07/054989尚未招募不适用

Clinico-Mycological Validation Of Dermatophytosis Severity Score And Its Correlation With Patient Reported Outcome Measures

Father muller research centre1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年7月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
试验地点
1
主要终点
Dermatophyte severity score

研究概览

简要总结

Dermatophytosis is a widespread superficial skin mycosis known to affect more than 20%–25%

of the human population1 . In recent years there has been a drastic shift in the disease

presentation, severity, treatment response, and rate of relapse2 .The increasing occurrence of

drug resistance is influenced by a multitude of factors ranging from delayed, inappropriate and

inadequate treatment to mutant fungal species. There is an epidemic rise of chronic and

recurrent dermatophytosis both globally and in India3 .Some patients with acute superficial

dermatophytosis are able to effectively clear the fungi, leading to resolution of the infection.

However, others who suffer from chronic and recurrent dermatophytoses are unable to develop

this response 4.

Bhat et al developed and validated an objective scoring tool for dermatophytosis through the

dermatophytosis severity score (DSS) 5 . The score assesses and combines various factors that

determine the severity and outcomes of dermatophytosis thereby creating an accurate and

reproducible severity scale. This new classification system is an important tool for clinicians since

the score can serve as a guide to treatment choice, and for the prediction of response to treatment.

However, there is a need to evaluate the variation of DSS with treatment and to assess whether it

reflects the changing course of illness. Patient-reported outcomes (PROs) are effective tools to

better understand a patient’s health condition, goals, and unique factors related to their care 6 .

When implementing an effective patient-centered care strategy it is vital for providers to track

PRO scores over time. There is an increasing emphasis both in dermatology and medicine to

adequately capture the patient The score needs to be corroborated with both clinical and

mycological parameters to assess its responsiveness to the change in the clinical status of the

patient and the mycological status of dermatophytosis.

The present study seeks to compare the DSS with the clinical status of the patient both

objectively as well as with the PRO scores.

IMPLICATIONS OF THE STUDY

Dermatophytosis has assumed epidemic proportions in India and furthermore, continues to be

ever increasing in its severity, resistance to treatment and relapse rate. This pilot study seeks to

validate DSS to determine its correlation with the clinical status of the patient, mycological response and PRO scores. The additional utility would be ease of communicating the findings

across a global platform would be greatly aided by validating the DSS in clinical settings and

observing its variation during the course of treatment.

Thus, it is of relevance to validate the scoring tool at point of care settings so as to document

disease severity and accordingly plan the treatment choice. Future studies can aid in assessing the

accuracy and reproducibility of the scale at different centres to improve its applicability.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • (i) Aged 18 years and above (ii) Clinically diagnosed cases of dermatophytosis involving the non glabrous skin.

排除标准

  • i)Patients aged below 18 years (ii) Patients with dermatophytosis with exclusive scalp, nail, palms, or soles (glabrous skin )involvement.
  • (iii) Patients with other co-existing papulo-squamous dermatoses involving the same areas in addition to dermatophytosis.

结局指标

主要结局

Dermatophyte severity score

时间窗: at baseline , 4weeks , 8weeks

次要结局

未报告次要终点

研究者

申办方类型
Private medical college

研究点 (1)

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