Efficacy and safety of Bacillus Calmette Guerin (BCG) vaccine and Purified protein derivative (PPD)in treatment of viral warts

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/12/005244
• Date of registration: 03-12-2014
• Prospective Registration: No
• Primary sponsor: Medical College Kolkata
• Public title: Efficacy and safety of Bacillus Calmette Guerin (BCG) vaccine and Purified protein derivative (PPD)in treatment of viral warts
• Scientific title: A double blind randomized control trial to compare the effectiveness, safety and tolerability of bacillus-calmette-guerin (BCG) vaccine and purified protein derivative (PPD) of tuberculin antigen in the treatment of multiple viral warts.
• Date of first enrolment: 05-05-2014
• Target sample size: 60
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9491
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: Phase 4

Countries of recruitment

India

Contacts

• Name: Nilay Kanti Das
• Affiliation: Medical College Kolkata

• Name: Amrita Sil
• Affiliation: Medical College Kolkata

Key inclusion & exclusion criteria

Inclusion criteria: i. Male or female patients between 18 and 65 years of age (both inclusive)

ii. Multiple viral warts (number > 10)

iii. Patients who give their informed consent


Exclusion criteria: i. Pregnant or lactating women

ii. Any evidence of immunosuppression (egg HIV infection, Organ transplantation, long term steroid use etc.)

iii. Any other systemic disease (egg liver, kidney disorder)

iv. Patients not giving their informed consent

v. Presence of mucosal wart(s)



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Multiple viral warts

Intervention(s)

Intervention1: Bacillus-calmette-guerin (BCG) vaccine: Freeze dried, powdered form of BCG vaccine is taken and diluted with 1 ml of normal saline, supplied with the vial of BCG vaccine.
After preparation, 0.1 ml of BCG vaccine is administered intralesionally or intrademally (as per criteria) with the help of an insulin syringe.
Each prepared vial is finished within 4 hours of opening, as per standard norms.
Route of administration of BCG:
Palmar, Plantar and facial warts - Intradermal injection on right arm (at deltoid muscle insertion)
Warts in other regions: Intralesional injection is given in the largest wart (candidate wart)

Control Intervention1: Purified Protein Derivative (PPD):
0.1 ml of PPD (5 TU in 0.1 ml) is administered intradermally.
Route of administration of BCG: Palmar, Plantar and facial warts - Intradermal injection on right arm (at deltoid muscle insertion) Warts in other regions: Intralesional injection is given in the largest wart (candidate wart)

Primary Outcome(s)

Number of wartsTimepoint: Baseline, 1, 2, 3, 4, 5, 6th month.

Every patient will be given treatment for 3 months (either BCG or PPD according to randomization) at monthly intervals. They will be followed up for the next 3 months, total study duration of 6 months.

Secondary Outcome(s)

Serum for Liver Function Test, urea, creatinine, Hemoglobin, Total count, Differential Count, Erythrocyte Sedimentation RateTimepoint: Screening visit, 3rd month visit

Secondary ID(s)

NIL

Source(s) of Monetary Support

Institutional Medical College Kolkata

Ethics review

Status: Approved
Approval date: 26/04/2014
Contact:

Institutional Ethics Committee for Human Research, Medical College, Kolkata