| CTRI Number |
CTRI/2023/05/053069 [Registered on: 23/05/2023] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
autoinoculation therapy in dermatophytosis |
|
Scientific Title of Study
|
SAFETY AND EFFICACY OF AUTOINOCULATION THERAPY IN CHRONIC RECALCITRANT DERMATOPHYTOSIS: A RANDOMIZED CONTROLLED TRAIL |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PRATIK GAHALAUT |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
MBBS , MD (DERMATOLOGY) |
| Address |
Department of dermatology,
SRMS IMS, Bareilly - Nainital Rd, Bhoji Pura, Uttar Pradesh
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9319758004 |
| Fax |
|
| Email |
drpratikg@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRATIK GAHALAUT |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
MBBS , MD (DERMATOLOGY) |
| Address |
Department of dermatology,
SRMS IMS, Bareilly - Nainital Rd, Bhoji Pura, Uttar Pradesh.
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9319758004 |
| Fax |
|
| Email |
drpratikg@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ARUJ DUDEA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
MBBS , MD DERMATOLOGY (undergoing) |
| Address |
Room no. 204, Usha Mehra P.G. boys hostel
SRMS IMS, Bareilly - Nainital Rd, Bhoji Pura, Uttar Pradesh.
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
7906721172 |
| Fax |
|
| Email |
aruj.srmsim@gmail.com |
|
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Source of Monetary or Material Support
|
| SRMS IMS MEDICAL COLLEGE
Bareilly - Nainital Rd, BhojiPura, Uttar Pradesh. |
|
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Primary Sponsor
|
| Name |
SRMS IMS MEDICAL COLLEGE |
| Address |
Bareilly - Nainital Rd, Bhoji Pura, Uttar Pradesh 243202 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ARUJ DUDEA |
SRMS INSTITUTE OF MEDICAL SCIENCES |
DEPARTMENT OF DERMATOLOGY, VENEROLOGY AND LEPROSY, NEAR GATE NO. 3, Bareilly - Nainital Rd, BhojiPura.
Bareilly
UTTAR PRADESH |
7906721172
aruj.srmsim@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRMS IMS, Bareilly |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AUTOINOCULATION |
simple technique that works by inducing cell-mediated immune response against the antigens essential for the clearance of dermatophytes.4mm tissue from edge of KOH positive site will be harvested and after breaking into small chunks, gently introduced deep into the subcutis using 16-gauge needle. BASELINE , 3 WEEKS , 6 WEEKS , 9 WEEKS are timepoints and total time of study is 3 months incukding all siitings. |
| Comparator Agent |
Placebo |
O.1 ML NORMAL SALINE is injected at the edge of KOH positive site as a placebo and oral/topical antifungal are given to patients. BASELINE , 3 WEEKS , 6 WEEKS , 9 WEEKS are timepoints and total time of study is 3 months incukding all visits. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving written informed consent.
Patients allowing to take photographs.
All patients of dermatophytosis showing positive result on KOH mount
Patients of chronic recalcitrant1 dermatophytosis.
|
|
| ExclusionCriteria |
| Details |
Patients refusing to participate in the study.
Patients not willing to give written informed consent/click photographs.
Pregnant/lactating females.
Patients with concomitant chronic systemic disease like Hypertension, Diabetes mellitus or on immunosuppressant drugs.
Patients showing hypersensitivity to lignocaine.
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Method of Generating Random Sequence
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Method of Concealment
|
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Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
| AUTOINOCULATION FROM KOH POSITIVE SITE WILL BE PERFORMED |
BASELINE , 3 WEEKS , 6 WEEKS , 9 WEEKS |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| PATIENT SATISFACTION GRADE WILL BE TAKEN INTO ACCOUNT ON EACH VISIT. |
BASELINE , 3 WEEKS , 6 WEEKS , 9 WEEKS |
|
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Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/06/2023 |
| Date of Study Completion (India) |
02/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
|