NCT05023408

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

August 19, 2021

Last Update Submit

August 25, 2021

Conditions

Cutaneous Warts

Keywords

cutaneous warts,intralesional bleomycin,cryotherapy,efficacy

Outcome Measures

Primary Outcomes (1)

  • change in morphology of cutaneous warts.

    There is complete remission of cutaneous warts, assessed clinically

    6 weeks

Study Arms (2)

Intralesional Bleomycin

EXPERIMENTAL

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

Drug: Bleomycin Injection

Cryotherapy

EXPERIMENTAL

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

Procedure: Cryotherapy

Interventions

Bleomycin InjectionDRUG

Intralesional Bleomycin used for treatment of cutaneous warts.

Also known as: Bleomycin Sulfate
Intralesional Bleomycin
CryotherapyPROCEDURE

Cryotherapy used for comparison of efficacy.

Cryotherapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age18 to 60 years
  • Either gender.
  • Diagnosed cases of cutaneous warts as per operational definition for \> 1 week to 48 weeks.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Postgraduate Medical Centre

Karachi, Sindh, 75510, Pakistan

Location

MeSH Terms

Interventions

BleomycinCryotherapy

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsTherapeutics

Study Officials

  • Rabia Ghafoor, FCPS

    Jinnah Postgraduate Medical Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
FCPS II Postgraduate Trainee

Study Record Dates

First Submitted

August 19, 2021

First Posted

August 26, 2021

Study Start

January 1, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)