Intralesional Vitamin D3 Versus Intralesional Acyclovir in Treatment of Plantar Warts

NCT05324904 | Unknown

• 1 other identifier: vitamin D3, acyclovir in warts
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate and compare the efficacy and safety of intralesional acyclovir versus intralesional vitamin D3 in the treatment of plantar warts

Conditions

Plantar Wart

Outcome Measures

Primary Outcomes (1)

• complete healing rate

  Main outcome variable is the complete healing rate among planter warts patients treated with intralesional vitamin D3 compared to those by Intralesional acyclovir

  12 weeks

Study Arms (2)

group 1

ACTIVE COMPARATOR

this group will be intralesionaly injected with vitamin D3

Drug: Vitamin D

group 2

ACTIVE COMPARATOR

this group will be intralesionally injected with acyclovir

Drug: acyclovir

Interventions

Vitamin D DRUG

\- Vitamin D * The aqueous solution of vitamin D3 (cholecalciferol) will be used ampoule 200,000 IU/2 ML, * Using a 27-gauge syringe with the bevel facing upward, a maximum of 0.6 ml (60,000 IU) of vitamin D3 solution will be slowly injected into the base of the largest plantar wart (large warts \> 10 mm need multiple injections at different sites) * Treatment sessions will be performed at 3-week intervals for a maximum of 4 sessions

group 1

acyclovir DRUG

-Acyclovir * Acyclovir vial (Zovirax® vial, 250mg, ) will be diluted with 3.5 ml saline to get approximately 70 mg /ml solution. * After sterilization of the skin, a 27-gauge syringe with the bevel facing upward will be inserted into the base of the largest plantar wart to slowly inject the solution * Treatment sessions will be performed at 2-week intervals for maximum of 5 sessions

group 2

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants of both sex with plantar warts will be included in the study

You may not qualify if:

• \- Children \< 12 years.
• Pregnant and lactating women.
• Receiving any treatment for warts within 1 month before the study.
• Systemic antiviral medication.
• Previous history of vitamin D or acyclovir hypersensitivity.
• Vitamin D supplementation.
• Concurrent other skin disorders.
• Immunosuppressive disorders or receiving immunosuppressive drugs.
• Receiving drugs that may alter vitamin D level including prednisone, orlistat, phenytoin and thiazide diuretics.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit University

Asyut, Egypt

Location

MeSH Terms

Interventions

Vitamin D; Acyclovir

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• maha m mostafa, MD

  Assuit University faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

maha m mostafa, MD

CONTACT

+201158597040; mahamostafaali@yahoo.com

maha m mostafa, MD

CONTACT

01158597040; mahamostafaali@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician of Dermatology, Venereology and Andrology, kom Ombo central hospital

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 13, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)