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