Validation Of Dermatphytosis Severity Score And Its Correlation With Patient ReportedOutcome Measures

Not yet recruiting

Conditions: Local infection of the skin and subcutaneous tissue, unspecified,

Registration Number: CTRI/2023/07/054989

Lead Sponsor: Father muller research centre

Brief Summary: Dermatophytosis is a widespread superficial skin mycosis known to affect more than 20%â€“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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dermatophyte severity score	at baseline , 4weeks , 8weeks

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Father muller medical college
🇮🇳
Kannada, KARNATAKA, India
Father muller medical college
🇮🇳Kannada, KARNATAKA, India
Dr Jiby V Benny
Principal investigator
9535435170
jibybenny@gmail.com