To compare efficacy of treatment by intralesional bleomycin and intralesional vitamin D-3 in common warts.

Completed

• Conditions: Other viral warts,

• Registration Number: CTRI/2021/04/032610
• Lead Sponsor: Department of Dermatology Venereology and Leprosy

Brief Summary

Verruca vulgaris or common warts, caused by Human Papilloma Virus presents as asymptomatic skin coloured, firm papules with a rough verrucous surface. Although no single therapy is considered as gold standard, multiple therapeutic options available for warts are:

1. Topical therapies- keratolytic agents such as salicylic acid; cytotoxic agents like 5-Fluorouracil, bleomycin and podophyllin; immunomodulators like imiquimod and caustics such as trichloroacetic acid.

2. Destructive therapies- electrofulguration, cryotherapy, laser ablation, excision, hyperthermia and photodynamic therapy.

3. Immunotherapies- vaccines such as BCG, MMR, Mycobacterium w; antigens such as candid antigen, PPD, vitamin D-3, IFN-alpha and contact sensitizers.

Topical therapy generally requires multiple sessions which results in poor patient compliance and has a higher risk of recurrence. Destructive modalities often require expensive equipment, cause scarring and dyspigmentation.

Immunotherapy has evoloved as a potential treatment modality for treatment of warts which acts by activating the patient’s immune system thus enhancing recognition and eradication of the virus. Vitamin D-3 is a recent introduction as immunotherapeutic agent which regulates epidermal proliferation and cytokine production.

Bleomycin, a cytotoxic agent has been U.S FDA approved for the treatment of various malignancies. When administered into the skin, it leads to apoptosis of keratinocytes by causing DNA breaks, endothelial cell sclerosis, and inhibition of collagen formation. The therapeutic efficacy of bleomycin in warts have been assessed by using various concentrations, doses and different methods of administration.

This study aims at comparing the therapeutic efficacy of intralesional bleomycin and intralesional vitamin D-3 in verruca vulgaris.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-04
• Study Completion: 2022-01-09
• Last Update Posted: 2022-09-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• All untreated consecutive patients having single/ multiple lesions of verruca vulgaris.
• Patients above the age of 14 years.

Exclusion Criteria

• Pregnant or lactating females.
• Immunocompromised individuals including HIV.
• Patients known to have hypersensitivity to vitamin D-3.
• Patients having history of peripheral vascular disorders like scleroderma or Raynaud’s phenomenon.
• Patients with pulmonary fibrosis.
• History of intake of vitamin D-3, anabolic steroids, bisphosphonates in the last 3 months or history of intravenous chemotherapy with bleomycin in the past.
• Patients having any significant systemic illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the therapeutic efficacy of intralesional bleomycin and intralesional vitamin D-3 in verruca vulgaris.	A total of three sessions at an interval of two weeks shall be instituted in both groups (i.e. 0, 2 and 4 weeks). Patients will be followed at 8th week.

Trial Locations

Locations (1)

Government Medical College and Hospital; 🇮🇳 Chandigarh, CHANDIGARH, India

Government Medical College and Hospital

🇮🇳Chandigarh, CHANDIGARH, India

Dr Ritu Mittal

Principal investigator

9646497534

mittalritu23@gmail.com