Comparative efficacy of intralesional bleomycin sulphate and intra-lesional Immunotherapy with Candida skin testing antigen in the treatment of palmoplantar warts.

Phase 2

Recruiting

• Conditions: PALMOPLANTAR WART

• Registration Number: CTRI/2018/01/011524
• Lead Sponsor: INDIAN COUNCIL OF MEDICAL RESEARCH

Brief Summary

Various studies have failed to reach at an idealtreatment modality which can be used for treatment of palmo-plantar warts whichare resistant to standard treatment.

 Both bleomycin and immunotherapy, individually, haveshown promising results in the management of these warts. But the studies havemostly been open label uncontrolled studies not targeting specifically theresistant palmoplantar warts.

 Indian data regarding the efficacy of both bleomycinand immunotherapy is limited. Moreover, no head to head study to compare theirefficacy has been done.

 Is bleomycin effective in clearing untreated warts asthere have been reports of distant warts getting cleared after intralesionalbleomycin therapy, but no study evaluating this parameter has been performed.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-15
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clearance of warts	Four weeks after the last dose of agent

Secondary Outcome Measures

Name	Time	Method
CLEARANCE OF DISTANT UNTREATED WART	4 and 12 weeks after the last dose of agent
Recurrence of completely cleared lesions	12 weeks after the last dose of agent
Delayed clearance of unresolved warts	12 weeks after the last dose of agent

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 South, DELHI, India

All India Institute of Medical Sciences

🇮🇳South, DELHI, India

MANIK AGGARWAL

Principal investigator

9654176455

manik07_aggarwal@hotmail.com