| CTRI Number |
CTRI/2018/01/011524 [Registered on: 23/01/2018] Trial Registered Prospectively |
| Last Modified On: |
09/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative efficacy of intralesional bleomycin sulphate and intra-lesional Immunotherapy with Candida skin testing antigen in the treatment of palmoplantar warts. |
|
Scientific Title of Study
|
Comparative efficacy of intra-lesional bleomycinsulphate and Immunotherapy with Candida skin testing antigen in the treatment of palmoplantar warts |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MANIK AGGARWAL |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no 4070, 4th floor,
department of dermatology and venereology
AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
manik07_aggarwal@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VINOD K SHARMA |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
DEPARTMENT OF DERMATOLOGY
Room no 4070, 4th floor,
department of dermatology and venereology
AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
vksiadvl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MANIK AGGARWAL |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no 4070, 4th floor,
department of dermatology and venereology
AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
manik07_aggarwal@hotmail.com |
|
|
Source of Monetary or Material Support
|
| INDIAN COUNCIL OF MEDICAL RESEARCH |
|
|
Primary Sponsor
|
| Name |
INDIAN COUNCIL OF MEDICAL RESEARCH |
| Address |
V. Ramalingaswami Bhawan
P.O. Box No. 4911
Ansari Nagar
New Delhi - 110029
India |
| Type of Sponsor |
Research institution |
|
|
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 |
| MANIK AGGARWAL |
All India Institute of Medical Sciences |
DEPARTMENT OF DERMATOLOGY
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,
ANSARI NAGAR,
NEW DELHI-110029
South
DELHI |
9654176455
manik07_aggarwal@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PALMOPLANTAR WART, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
bleomycin sulphate |
freeze dried powder to be reconstituted with distilled water |
| Comparator Agent |
candy skin testing antigen |
2% w/v |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age- Adult males and females aged 18-65 years.
2. Multiple plantar warts diagnosed on the basis of history and physical examination by two dermatologists.
Palmoplantar warts will be defined as sharply defined, hyperkeratotic rough lesions with loss of epithelial ridges over the surface of the lesion with a smooth collar of thickened horn present over the palmar or plantar surfaces.
3. Untreated or no treatment in the last four weeks.
|
|
| ExclusionCriteria |
| Details |
1. Known immune-compromised state such as history of HIV infection, on steroids and other immunosuppressive drugs.
2. Past history of immunotherapy or bleomycin sulphate.
3. Warts measuring more than 20cm2 in size.
4. Local site infection.
5. Pregnant and lactating females.
6. Any history of chronic cardiac, renal and pulmonary illness, peripheral vascular disease, Raynaud’s disease.
7. Unable to give informed consent.
8. Allergy to components of candida antigen or bleomycin sulphate.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clearance of warts |
Four weeks after the last dose of agent |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Delayed clearance of unresolved warts |
12 weeks after the last dose of agent |
| Recurrence of completely cleared lesions |
12 weeks after the last dose of agent |
| CLEARANCE OF DISTANT UNTREATED WART |
4 and 12 weeks after the last dose of agent |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/02/2018 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Various studies have failed to reach at an ideal
treatment modality which can be used for treatment of palmo-plantar warts which
are resistant to standard treatment.
Both bleomycin and immunotherapy, individually, have
shown promising results in the management of these warts. But the studies have
mostly been open label uncontrolled studies not targeting specifically the
resistant palmoplantar warts.
Indian data regarding the efficacy of both bleomycin
and immunotherapy is limited. Moreover, no head to head study to compare their
efficacy has been done.
Is bleomycin effective in clearing untreated warts as
there have been reports of distant warts getting cleared after intralesional
bleomycin therapy, but no study evaluating this parameter has been performed.
|