Intralesional Acyclovir Versus Cryotherapy in the Treatment of Plantar Warts. A Randomized Controlled Trial.

Plantar Wart Clinical Trial

Official title:

Intralesional Acyclovir Versus Cryotherapy in the Treatment of Plantar Warts. A Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06261684
• Other study ID #: MS-259-2023
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Basant Helal, MRCP
• Phone: +201144166922
• Email: basant_helal[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. Is Intralesional acyclovir safe for plantar warts?

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Foot Diseases
• Plantar Wart
• Warts

Intervention

Drug:
• Intralesional Acyclovir
Intralesional Acyclovir in plantar warts

Device:
• Cryotherapy
Cryotherapy of plantar warts

Locations

Country	Name	City	State
Egypt	Cairo University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate	Number of patients healed after completion of the sessions	10 weeks (5 sessions max)
Primary	Recurrence rate	Number of patients had recurred plantar warts after receiving the treatment	24 weeks
Primary	Patient satisfaction score	Patient satisfaction questionnaire score	10 weeks
Secondary	Correlation of treatment with number of ipsilateral warts	Number of warts increased, decreased or stationary	10 weeks
Secondary	Correlation of treatment with age	Percentage of patients successfully treated in each age group (Young 18-32 years; Middle age 33-46, Old age 47-60	10 weeks
Secondary	Correlation of treatment with gender	Percentage of successfully treated male to female patients	10 weeks
Secondary	Correlation of treatment with size of the wart	Percentage of successful treatment compared to the size of the wart	10 weeks