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Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts

Primary Purpose

Cutaneous Warts

Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Bleomycin Injection
Cryotherapy
Sponsored by
Jinnah Postgraduate Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Warts focused on measuring cutaneous warts,intralesional bleomycin,cryotherapy,efficacy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Jinnah Postgraduate Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intralesional Bleomycin

Cryotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

change in morphology of cutaneous warts.
There is complete remission of cutaneous warts, assessed clinically

Secondary Outcome Measures

Full Information

First Posted
August 19, 2021
Last Updated
August 25, 2021
Sponsor
Jinnah Postgraduate Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05023408
Brief Title
Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts
Official Title
Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinnah Postgraduate Medical Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Warts
Keywords
cutaneous warts,intralesional bleomycin,cryotherapy,efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intralesional Bleomycin
Arm Type
Experimental
Arm Description
Intralesional Bleomycin has been given to palmo plantar warts. Generic name: Bleomycin Dose: 1mg/1ml (0.1%) Frequency: every 2 weekly for 6 weeks.
Arm Title
Cryotherapy
Arm Type
Experimental
Arm Description
Cryotherapy has been given to palmo plantar warts. Frequency: every 2 weekly for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Bleomycin Injection
Other Intervention Name(s)
Bleomycin Sulfate
Intervention Description
Intralesional Bleomycin used for treatment of cutaneous warts.
Intervention Type
Procedure
Intervention Name(s)
Cryotherapy
Intervention Description
Cryotherapy used for comparison of efficacy.
Primary Outcome Measure Information:
Title
change in morphology of cutaneous warts.
Description
There is complete remission of cutaneous warts, assessed clinically
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabia Ghafoor, FCPS
Organizational Affiliation
Jinnah Postgraduate Medical Centre
Official's Role
Study Director
Facility Information:
Facility Name
Jinnah Postgraduate Medical Centre
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75510
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts

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