| CTRI Number |
CTRI/2020/04/024864 [Registered on: 27/04/2020] Trial Registered Prospectively |
| Last Modified On: |
16/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study of skin features, laboratory features and response to treatment with various anti-fungal drugs in patients with recurrent superficial fungal infections |
|
Scientific Title of Study
|
A clinico-epidemiological, microbiological, histopathological and therapeutic study of recurrent dermatophytosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Urmila Yellamelli |
| Designation |
Postgraduate student, M.D (DVL) |
| Affiliation |
Maharajahs institute of medical sciences |
| Address |
Department of Dermatology
OP room no: 1
Nellimarla
Vizianagaram
Vizianagaram
ANDHRA PRADESH
535217
India |
| Phone |
9110398582 |
| Fax |
|
| Email |
dr_urmila@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Narayana Rao |
| Designation |
Professor & HOD, Dept. of Dermatology |
| Affiliation |
Maharajahs institute of medical sciences |
| Address |
Department of Dermatology
OP room no: 1
Nellimarla
Vizianagaram
Vizianagaram
ANDHRA PRADESH
535217
India |
| Phone |
9849129912 |
| Fax |
|
| Email |
tnr_derma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Urmila Yellamelli |
| Designation |
Postgraduate student |
| Affiliation |
Maharajahs institute of medical sciences |
| Address |
Department of Dermatology
OP room no: 1
Nellimarla
Vizianagaram
Vizianagaram
ANDHRA PRADESH
535217
India |
| Phone |
9110398582 |
| Fax |
|
| Email |
dr_urmila@outlook.com |
|
|
Source of Monetary or Material Support
|
| Maharajahs Institute Of Medical Sciences, Nellimarla, Vizianagaram, Andhra Pradesh, India. Pincode: 535217 |
|
|
Primary Sponsor
|
| Name |
Maharajahs institute of medical sciences |
| Address |
Department of Dermatology
OP room no: 1
Nellimarla
Vizianagaram |
| Type of Sponsor |
Private 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 |
| Urmila Yellamelli |
Maharajahs institute of medical sciences |
Department of Dermatology
OP room no: 1
Nellimarla
Vizianagaram
Vizianagaram
ANDHRA PRADESH |
9110398582
dr_urmila@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, maharajahs institute of medical sciences |
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 |
Griseofulvin |
group A - griseofulvin 10 mg/kg body weight in two divided doses per day, for a period of 6 weeks. |
| Comparator Agent |
Griseofulvin and terbinafine |
Group D -griseofulvin 10mg/kg body weight and terbinafine 5 mg/kg body weight in two divided doses per day, for a period of 6 weeks. |
| Comparator Agent |
Itraconazole |
Group C - systemic itraconazole 5 mg/kg body weight in two divided doses per day, for a period of 6 weeks. |
| Comparator Agent |
Itraconazole and Griseofulvin |
Group F - Itraconazole 5 mg/kg body weight and griseofulvin 10 mg/kg body weight in two divided doses per day, for a period of 6 weeks. |
| Comparator Agent |
Itraconazole and Terbinafine |
Group E - Itraconazole 5 mg/kg body weight and terbinafine 5 mg/kg body weight in two divided doses per day, for a period of 6 weeks. |
| Comparator Agent |
Terbinafine |
Group B - terbinafine 5 mg /kg body weight in two divided doses per day, for a period of 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed cases of recurrent dermatophytoses infection with at least one episode of relapse with 4Â weeks of completing the recommended duration of anti fungal therapy.
2. Both sexes between the age groups 18 - 70 yrs. |
|
| ExclusionCriteria |
| Details |
1. Infants, patients below 18 years and above 70 years
2. Immunocompromised patients (HIV).
3. Pregnant and lactating females.
4. Patients receiving multiple drugs (glucocorticoids, statins, etc.) for other medical conditions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Clinical profile of recurrent dermatophytic infections prevalent in this region will be recorded.
2. The mycological profile and histopathological profile in recurrent dermatophytosis will be recorded.
3. Therapeutic efficacy of single and combinations of systemic antifungal drugs in recurrent dermatophytic infections will be reported. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To note recurrences in the follow up period of 3 months |
3 months |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
01/05/2020 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised, double blind, parallel group, multi arm trial comparing the therapeutic efficacy of various systemic anti fungal drugs in recurrent dermatophytic infections. A detailed history including the previous treatment history will be taken and clinical examination will be done. In all suspected cases of recurrent dermatophytic infections, specimens will be collected by scraping the active edge of the affected skin and will be subjected to direct microscopic examination using 10%KOH. A part of the collected specimen will also be sent for fungal culture in sterile specimen bottle.Sabourads dextrose agar slopes will be used for primary isolation and Dermatophyte test medium will be used as selective medium. Species identification will be done by colony morphology and microscopy on Lactophenol cotton blue mount. Skin biopsy from affected site will be done and sent for histopathological examination. In GMS and PAS stain specimens, the presence of fungal hypae in all layers of epidermis, hair follicle and other structures will be studied. All subjects will be divided into 6 groups of 30 each by randomisation using computer based softwares and are given systemic antifungals to know the therapeutic efficacy after 6 weeks. |