Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts

NCT ID: NCT05023408

Last Updated: 2021-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-06-30

Brief Summary

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

Detailed Description

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.

Conditions

Cutaneous Warts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intralesional Bleomycin

Intralesional Bleomycin has been given to palmo plantar warts. Generic name: Bleomycin Dose: 1mg/1ml (0.1%) Frequency: every 2 weekly for 6 weeks.

Group Type: EXPERIMENTAL

Bleomycin Injection

Intervention Type: DRUG

Intralesional Bleomycin used for treatment of cutaneous warts.

Cryotherapy

Cryotherapy has been given to palmo plantar warts. Frequency: every 2 weekly for 6 weeks

Group Type: EXPERIMENTAL

Cryotherapy

Intervention Type: PROCEDURE

Cryotherapy used for comparison of efficacy.

Interventions

Bleomycin Injection

Intralesional Bleomycin used for treatment of cutaneous warts.

Intervention Type: DRUG

Cryotherapy

Cryotherapy used for comparison of efficacy.

Intervention Type: PROCEDURE

Other Intervention Names

Bleomycin Sulfate

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jinnah Postgraduate Medical Centre

OTHER_GOV

Sponsor Role: lead

Responsible Party

Javaria Rahmatullah

FCPS II Postgraduate Trainee

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rabia Ghafoor, FCPS

Role: STUDY_DIRECTOR

Jinnah Postgraduate Medical Centre

Locations

Jinnah Postgraduate Medical Centre

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

JinnahPMC

Identifier Type: -

Identifier Source: org_study_id