| CTRI Number |
CTRI/2019/07/020070 [Registered on: 08/07/2019] Trial Registered Prospectively |
| Last Modified On: |
05/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of Intradermal versus Intralesional Purified Protein Derivative (PPD) for treatment of common warts in children |
|
Scientific Title of Study
|
To Compare the efficacy and safety of Intradermal versus Intralesional Purified Protein Derivative (PPD) for treatment of Common warts in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monika chandel |
| Designation |
Junior resident |
| Affiliation |
Department of dermatology Dr rpgmc tanda |
| Address |
Department of dermatology Dr rpgmc tanda kangra
Department of dermatology Dr rpgmc tanda kangra HP
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8988186582 |
| Fax |
|
| Email |
dr.monikachandel555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KS Mehta |
| Designation |
Professor |
| Affiliation |
Department of dermatology Dr rpgmc tanda |
| Address |
Department of dermatology Dr rpgmc tanda kangra
Department of dermatology Dr rpgmc tanda kangra HP
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418457647 |
| Fax |
|
| Email |
drkaranindermehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika chandel |
| Designation |
Junior resident |
| Affiliation |
Department of dermatology Dr rpgmc tanda |
| Address |
Department of dermatology Dr rpgmc tanda kangra
Department of dermatology Dr rpgmc tanda kangra HP
HIMACHAL PRADESH
176001
India |
| Phone |
8988186582 |
| Fax |
|
| Email |
dr.monikachandel555@gmail.com |
|
|
Source of Monetary or Material Support
|
| Available in Dr rpgmc tanda kangra HP |
|
|
Primary Sponsor
|
| Name |
Himachal Pradesh University |
| Address |
Department of dermatology Dr rpgmc tanda kangra HP 176001 |
| 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 |
| Dr monika chandel |
Dr rpgmc and Hospital |
Department of dermatology room no.136 Dr rpgmc tanda kangra HP 176001
Kangra
HIMACHAL PRADESH |
8988186582
dr.monikachandel555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Protocol Review Board and Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection purified protein derivative |
Given as 10 tuberculin units per 0.1ml intradermal and Intralesional at 2,4,6,8 weeks interval and patient asked to return for follow up at 12weeks to see any recurrence of warts or any adverse events. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children of age 5 to 15 years clinically diagnosed with common warts |
|
| ExclusionCriteria |
| Details |
Patients with immune suppression from any disease or drug therapy |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Not yet recruiting |
Not yet recruiting |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
14/07/2019 |
| 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="0"
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)?
|
|
Brief Summary
|
I am going on intervention study include title to compare the efficacy and safety of Intradermal versus Intralesional Purified Protein Derivative (PPD) in treatment of Common warts in children.Dose schedule of PPD include 10TU per0.1 ml given intradermal and Intralesional at 2weekly interval upto 8weeks and asked patient to follow up at 12weeks to see resolution of warts. |