A clinical trial to study the effect of two drugs- Mycobacterium w vaccine and imiquimod in patients with genital warts

A comparative study of effectiveness of immunotherapy with intralesional injection of killed Mycobacterium w vaccine and imiquimod cream in clinical resolution and reduction of viral load: A randomized trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000055

Enrollment

110

Registered

2009-02-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients with anogenital warts

Interventions

Intervention1: Mycobacterium w vaccine: Maximum up to 0.1 ml in one session Control Intervention1: 5% Imiquimod cream: 3 times a week for 16 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with one or more anogenital warts, with surface area of warts 10 mm2 or more 2. Patients are otherwise healthy adults, >12 years of age. 3. Received no treatment during past 4 weeks

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women 2. HIV seropositive patient 3. Patients on profound iatrogenic immunosuppression 4. Patients with serious systemic disorder 5. Patients with substance or alcohol dependence 6. Known cases of cervical intraepithelial neoplasia

Design outcomes

Primary

Measure	Time frame
Complete remission of anogenital warts.Timepoint: 16 weeks	—

Secondary

Measure	Time frame
change in HPV viral load, response to treatment defined as >75% reduction in size and Sustained clearance rateTimepoint: 16 weeks, 16 weeks, and 28 weeks, respectively	—

Countries

India

Contacts

Public ContactDr. Somesh Gupta

AIIMS, New Delhi

someshgupta@hotmail.com01126546626

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 7, 2026