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Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts

Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05023408
Enrollment
154
Registered
2021-08-26
Start date
2021-01-01
Completion date
2021-06-30
Last updated
2021-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Warts

Keywords

cutaneous warts,intralesional bleomycin,cryotherapy,efficacy

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.

Interventions

Intralesional Bleomycin used for treatment of cutaneous warts.

PROCEDURECryotherapy

Cryotherapy used for comparison of efficacy.

Sponsors

Jinnah Postgraduate Medical Centre
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
change in morphology of cutaneous warts.6 weeksThere is complete remission of cutaneous warts, assessed clinically

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026