| CTRI Number |
CTRI/2018/03/012838 [Registered on: 26/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
05/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of prescriptions to analyse the treatment being given to patients suffering from ring worm infection |
|
Scientific Title of Study
|
Prescription audit of anti-fungal treatment of dermatophytoses in the Dermatology out patient department of a tertiary care hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yashashri C Shetty |
| Designation |
Associate Professor |
| Affiliation |
Seth G S Medical College and K E M Hospital |
| Address |
Department of Pharmacology and Therapeutics
Seth G S Medical College and K E M Hospital Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869193041 |
| Fax |
|
| Email |
yashashrirajit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yashashri C Shetty |
| Designation |
Associate Professor |
| Affiliation |
Seth G S Medical College and K E M Hospital |
| Address |
Department of Pharmacology and Therapeutics
Seth G S Medical College and K E M Hospital Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869193041 |
| Fax |
|
| Email |
yashashrirajit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yashashri C Shetty |
| Designation |
Associate Professor |
| Affiliation |
Seth G S Medical College and K E M Hospital |
| Address |
Department of Pharmacology and Therapeutics
Seth G S Medical College and K E M Hospital Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869193041 |
| Fax |
|
| Email |
yashashrirajit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Diamond Jubilee Society Trust
Seth G S Medical College and K E M Hospital
Parel
Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Diamond Jubilee society trust |
| Address |
Seth G S Medical College and K E M Hospital
Parel Mumbai |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Yashashri C Shetty |
Seth G S Medical College and K E M Hospital |
Department of Pharmacology and Therapeutics
First floor
College building
Mumbai
MAHARASHTRA |
9869193041
yashashrirajit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, patients diagnosed with dermatophytoses in the opd, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients aged 12 to 65 years
2 Either genders
3 Newly diagnosed patients
4 Follow-up patients already on anti fungal therapy
5 Patients willing to give written informed consent and assent |
|
| ExclusionCriteria |
| Details |
1 patients diagnosed with tinea unguium tinea capitis or Majocchi granuloma
2 Any other concomitant skin diseases such as psoriasis eczema etcetra
3 Other systemic illnesses being treated with drugs such as rifampicin phenytoin etcetra which may result in drug interactions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the prescriptions of clinically diagnosed cases of dermatophytoses |
4 to 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate treatment of clinical failure cases
To estimate rise in serum ALT levels
To evaluate availability of drugs in hospital pharmacy
Cost minimization analysis of oral antifungal drugs prescribed
|
4 to 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="370"
Sample Size from India="370"
Final Enrollment numbers achieved (Total)= "370"
Final Enrollment numbers achieved (India)="370" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2015 |
| Date of Study Completion (India) |
19/09/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="19" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in International Journal of Clinical and Experimental Dermatology in September 2019 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients who were diagnosed with dermatophytoses infection in the Dermatology OPD, were recruited after obtaining their written informed consent or assent. These patients were followed up every 2 to 4 weeks for up to a total of 3 visits in case of treatment naive (New) patients and a total of 2 visits in case of patients already on anti-fungal therapy (Old cases). History of the patient was taken on the day of recruitment. The prescriptions were noted down at each visit. Clinical status was noted at each visit. Each patient was given a score of 0 to 3 for their symptoms of erythema, pruritus and desquamation based on their severity (Nil=0, Mild=1, Moderate=2, Severe=3). The patients were then categorised as clinically cured, clinical improvement and clinical failure groups. Blood samples for serum ALT levels were taken twice 2-4 weeks apart. In case of treatment naive patients, it was done on the 2nd and 3rd visits. In case of patients already on ongoing treatment, it was done on the 1st and 2nd visits. Availability of medications in the hospital pharmacy was checked at regular intervals. Patients who presented to the OPD for both the blood sample collection were considered to have completed the study.
Results:
Out of the 370 patients who were enrolled, 93 eventually completed the study. New and old cases constituted 46% and 54% of all patients respectively. The median age of patients was 33.5 years. The majority of patients (27.83%) belonged to the age group of 31-40 years. Males and females constituted 46% and 54% of the sample size respectively. The largest group of patients consisted of homemakers (34.86%) and students (18.64%). Tinea corporis constituted the highest number of cases (50.27%) followed by a combination of tinea corporis and tinea cruris (28.37%).
A total of 506 prescriptions were analysed. These included various formulations of anti-fungal drugs and anti-pruritic drugs. Azoles were the most commonly prescribed anti-fungal drug class. Clinical status of patients was independent of the oral anti-fungal drug prescribed. There was non-uniformity in the pharmacological management of patients who failed treatment. A statistically significant increase in serum ALT levels was seen (p<0.05) however, it was not clinically significant. About 55.52% drugs were unavailable in the hospital pharmacy during the entire duration of the study. This led to out-of -pocket expenses for patients. The average expenses per prescription for a duration of 3 weeks was INR 1123.55. Itraconazole regimen was found to be the most expensive for a duration of 3 weeks, followed by terbinafine and fluconazole.
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