| CTRI Number |
CTRI/2024/05/067543 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to access the effect of drug therapy
in Recalcitrant Dermatophytosis patients |
|
Scientific Title of Study
|
A Prospective observational study to analyse
the treatment response, tolerability and
prescribing pattern in patients receiving
treatment for Recalcitrant Dermatophytosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priti Kochar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Room No-3014
Level-4
Department Of Pharmacology
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8178843791 |
| Fax |
|
| Email |
payalkochar5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Bisht |
| Designation |
Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Room No-3002
Level-4
Department Of Pharmacology
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8475000263 |
| Fax |
|
| Email |
manisha.phar@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Bisht |
| Designation |
Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Room No-3002
Level-4
Department Of Pharmacology
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8475000263 |
| Fax |
|
| Email |
manisha.phar@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Priti kochar |
| Address |
Room no-3014, level-4, Department of Pharmacology, AIIMS, Rishikesh |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priti Kochar |
AIIMS Rishikesh |
Room No-3014
Level-4
Department Of Pharmacology
AIIMS Rishikesh
Dehradun
UTTARANCHAL |
8178843791
payalkochar5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B359||Dermatophytosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All the patients diagnosed with recalcitrant dermatophytosis operational definition of Recalcitrant dermatophytosis refers to relapse,
recurrences, reinfection, persistence or chronic infections, and possibly microbiological resistance.
2. Both male and female with established recalcitrant dermatophytosis.
3. Age 18- 60 years. |
|
| ExclusionCriteria |
| Details |
1.Patient diagnosed with other autoimmune dermatological disease like psoriasis.
2. Patient with cutaneous adverse drug reactions.
3. Patient with secondary infected tinea infection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyse the treatment response to antifungals drugs in patients diagnosed with recalcitrant dermatophytosis patients. |
At baseline and four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the prescribing pattern of anti-fungal agents and adherence
to available treatment guidelines.
2. To evaluate the adverse drug reactions, patient’s adherence to
treatment and cost of therapy associated with recalcitrant
dermatophytosis medication.
3. To assess the effect of antifungal therapy on the quality of life of
patients.
4. Subgroup analysis – Comparison of treatment response in patients
receiving different antifungal agents will be done, if feasible. |
At baseline and four weeks |
|
|
Target Sample Size
|
Total Sample Size="347"
Sample Size from India="347"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Recalcitrant dermatophytosis refers to the relapse, recurrence, reinfection, persistence, and possibly microbiological resistance of dermatophytosis. In the last 6-7 years dermatologists have seen an increase in chronic and recurrent dermatophytosis. Superficial fungal infections account for nearly 25%of global skin mycoses making these infections one of the most common types of infectious diseases worldwide. The rising epidemic of recalcitrant dermatophytosis is also adversely impacting the physical, mental, and financial health of the patients..A wide variety of antifungals are available for the treatment of recalcitrant dermatophytosis. While patients often experience symptomatic relief through pharmacological management in recalcitrant dermatophytosis, their responses to drugs vary significantly. There is a lack of clear-cut guidelines and efficacy for preferred antifungal agents. The duration of the treatment is also not well defined. This disease is also affecting the quality of life of the patients. Therefore, the present study is designed to assess the treatment response to prescribed drug therapy and analyze the prescribing pattern in recalcitrant dermatophytosis patients. |