NCT06718192

Brief Summary

To evaluate the efficacy of bleomycin and cryopreservation in the treatment of plantar verruca by dermoscopy and explore the influencing factors. Compare the safety, economic burden and impact on quality of life of the two treatments

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

December 25, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

December 2, 2024

Last Update Submit

March 20, 2025

Conditions

Verruca Plantaris

Keywords

verruca plantarisBleomycincryotherapyefficiencysecurity

Outcome Measures

Primary Outcomes (1)

  • the rate of warts complete clearance

    2 weeks after treatment endpoint

Study Arms (2)

Bleomycin Group

ACTIVE COMPARATOR
Other: Bleomycin injection

cryotherapy

OTHER
Other: Cryotherapy

Interventions

Bleomycin injectionOTHER

Wart injection (0.2 mL \<5 mm; 0.5 mL 5-10 mm; 1ml for \>10 mm) were injected at a depth of 1.5mm, diluted with normal saline at a concentration of 3u/ml=3mg/ml, and the maximum amount of each wart was 1ml until the wart turned white

Bleomycin Group
CryotherapyOTHER

The wart was frozen by liquid nitrogen until a circle of frozen tissue appeared around the wart for about 10s, with an interval of 30s, for a total of 2 times

cryotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years old, gender is not limited; Consistent with the diagnosis of plantar warts; Volunteer for treatment and sign informed consent; Consent to photograph the lesion; The treatment target area can be selected (the target area must meet the following conditions: The distance between adjacent warts in the target area is \>0.5cm; The diameter of a single wart in the target area is ≤1.5cm, and/or the diameter of a wart mass is ≤1.5cm; The number of total warts/wart masses in the target area is ≤10).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Yiwu, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

BleomycinCryotherapy

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsTherapeutics

Central Study Contacts

Lunfei Liu, Master

CONTACT

17816698735liulunfei_zeyy@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2024

First Posted

December 5, 2024

Study Start

December 25, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)