Clinical trial NCT05023408: Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts
Official title: Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cutaneous Warts
Keywords: cutaneous warts,intralesional bleomycin,cryotherapy,efficacy
Lead sponsor: Jinnah Postgraduate Medical Centre
Sponsor class: OTHER_GOV
First posted: 2021-08-26
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: change in morphology of cutaneous warts.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Jinnah Postgraduate Medical Centre
state: Sindh
Study officials:
affiliation: Jinnah Postgraduate Medical Centre
name: Rabia Ghafoor, FCPS
role: STUDY_DIRECTOR
References: