NCT06261684

Brief Summary

The goal of this prospective randomized controlled study is to study the safety and efficacy of intralesional acyclovir compared to cryotherapy in plantar warts. The main questions needed to be answered are:

  1. 1.Is Intralesional acyclovir safe for plantar warts?
  2. 2.Is Intralesional acyclovir more efficient in treating plantar warts compared to cryotherapy?

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2023

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

October 1, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

October 6, 2023

Last Update Submit

February 13, 2024

Conditions

Plantar Wart

Outcome Measures

Primary Outcomes (3)

  • Cure rate

    Number of patients healed after completion of the sessions

    10 weeks (5 sessions max)

  • Recurrence rate

    Number of patients had recurred plantar warts after receiving the treatment

    24 weeks

  • Patient satisfaction score

    Patient satisfaction questionnaire score

    10 weeks

Secondary Outcomes (4)

  • Correlation of treatment with number of ipsilateral warts

    10 weeks

  • Correlation of treatment with age

    10 weeks

  • Correlation of treatment with gender

    10 weeks

  • Correlation of treatment with size of the wart

    10 weeks

Study Arms (2)

Intralesional Acyclovir

EXPERIMENTAL

Intralesional acyclovir will be prepared by diluting 1 ampoule of Acyclovir 250mg into 3.5ml of saline solution to achieve a concentration of approximately 70mg/ml. Then 0.1ml will be injected intra-lesionally into the base of the wart. Any hyperkeratotic lesions should be pared before the treatment. This process will be repeated every 2 weeks for 5 sessions, and can be discontinued if complete resolution is achieved early.

Drug: Intralesional Acyclovir

Cryotherapy

ACTIVE COMPARATOR

Patients allocated to Group B will undergo cryotherapy using a liquid nitrogen spray gun. Any hyperkeratotic lesions should be pared before the treatment. Two freeze-thaw cycles will be applied each session, the spray gun should be held 1cm away from the wart and maintained until the wart and the 1-3mm of surrounding skin shows freezing, and each cycle should last 15 seconds. Next, the lesion will be left to thaw completely before starting the second cycle. This process will be repeated every 2 weeks for 5 sessions, and can be discontinued if complete resolution is achieved early

Device: Cryotherapy

Interventions

Intralesional AcyclovirDRUG

Intralesional Acyclovir in plantar warts

Intralesional Acyclovir
CryotherapyDEVICE

Cryotherapy of plantar warts

Cryotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years or older, of both genders, with plantar warts

You may not qualify if:

  • Patients on systemic treatment for warts eg. Acitretin, Acyclovir
  • Hypersensitivity to Acyclovir
  • Previous treatment to the same wart during the last 3 months
  • Immunocompromised patients (as HIV, steroid intake, uncontrolled diabetes, etc.)
  • Pregnant and breastfeeding females
  • Cognitively impaired patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospital

Cairo, Egypt

RECRUITING

Related Publications (2)

  • Elsayed A, Nassar A, Marei A, Hoseiny HAM, Alakad R. Intralesional Acyclovir: A Potential Therapeutic Option for Cutaneous Warts. J Cutan Med Surg. 2022 Jan-Feb;26(1):25-30. doi: 10.1177/12034754211037998. Epub 2021 Aug 19.

    PMID: 34412535BACKGROUND

  • Garcia-Oreja S, Alvaro-Afonso FJ, Tardaguila-Garcia A, Lopez-Moral M, Garcia-Madrid M, Lazaro-Martinez JL. Efficacy of cryotherapy for plantar warts: A systematic review and meta-analysis. Dermatol Ther. 2022 Jun;35(6):e15480. doi: 10.1111/dth.15480. Epub 2022 Apr 6.

    PMID: 35365922BACKGROUND

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Shahira Ramadan, Professor

    Cairo University

    STUDY CHAIR

  • Yousra Azzazi, Lecturer

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Basant Helal, MRCP

CONTACT

+201144166922basant_helal@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dermatology Resident

Study Record Dates

First Submitted

October 6, 2023

First Posted

February 15, 2024

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

February 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)