Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts

Cutaneous Warts Clinical Trial

Official title:

Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05023408
• Other study ID #: JinnahPMC
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: Jinnah Postgraduate Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cutaneous Warts
• Warts

Intervention

Drug:
• Bleomycin Injection
Intralesional Bleomycin used for treatment of cutaneous warts.

Procedure:
• Cryotherapy
Cryotherapy used for comparison of efficacy.

Locations

Country	Name	City	State
Pakistan	Jinnah Postgraduate Medical Centre	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Jinnah Postgraduate Medical Centre

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in morphology of cutaneous warts.	There is complete remission of cutaneous warts, assessed clinically	6 weeks