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Completed

NCT Number: NCT05023408

Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts

The purpose of the study was to determine the efficacy of intralesional bleomycin in comparison to cryotherapy on participants having cutaneous warts.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jinnah Postgraduate Medical Centre

Karachi, Sindh, 75510, Pakistan

About this study

This study was conducted in the Department of Dermatology of Jinnah Postgraduate Medical Centre, Karachi from January to June 2021 after receiving approval from the institutional ethical and research committee of hospital.

Sample size was calculated through NCSS software. Total of one fifty four non-admitted patients were assigned two study groups with equal sample size of 77 randomly through lottery method. Those patients aged between 18 to 60 years of either gender with cutaneous warts for > 1 week to 48 weeks were included after written informed consent. Patients treated previously for warts by any methodology, with history of vascular disease, immunocompromised, hypertension, cardiovascular disorder, pregnancy, lactation and hypersensitivity to lidocaine were excluded.

All demography, clinical history was recorded by a principal investigator on a predesigned Performa , informed written consent was taken before enrolment.

Group A received intralesional bleomycin 0.1% therapy until the lesion blanched. It was prepared manually by diluting 15 mg powder in 5 ml distilled water and then each ml was further diluted by adding 2ml of 2% lignocaine, double the amount taken from the vial, so that concentration became 1mg/1ml (0.1%). Group B patients were treated with liquid nitrogen with the help of a cotton swab wrapped on a wooden stick and was applied firmly with 01 mm extra healthy skin margin until the lesion blanched.

Follow-up was carried out at 02, 04 and 06 weeks. Both the groups were assessed and compared for efficacy after 6 weeks of therapy. SPSS 23 was used for analyzing data.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Age18 to 60 years
  • Either gender.
  • Diagnosed cases of cutaneous warts as per operational definition for > 1 week to 48 weeks.

Exclusion criteria

  • • Previously treated for warts by any methodology, assessed by history and clinically.
  • Patients with hypertension, cardiovascular disorder, pregnancy, lactation, vascular diseases, assessed by history, clinically & by positive autoimmune profile.
  • Hypersensitivity to lidocaine.
  • No given informed written consent.

Treatment and study plan

Bleomycin Injection

Drug

Intralesional Bleomycin used for treatment of cutaneous warts.

Other names: Bleomycin Sulfate

cryotherapy

Procedure

Cryotherapy used for comparison of efficacy.

Primary outcomes

  1. change in morphology of cutaneous warts.

    Time frame: 6 weeks

    There is complete remission of cutaneous warts, assessed clinically

Sponsors and collaborators

Lead sponsor

Jinnah Postgraduate Medical Centre

Other Gov

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2021
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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