Intralesional Vitamin D3 Versus Intralesional Acyclovir in Treatment of Plantar Warts

NCT ID: NCT05324904

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2023-11-30

Brief Summary

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

Detailed Description

Introduction Warts are common epidermal growths caused by various strains of human papillomavirus (HPV) affecting all age groups. They have an unsightly appearance and are mostly asymptomatic but sometimes may be painful as in the case of palmoplantar warts . Plantar warts is a clinical variant that occur on sole of the foot, most frequently over pressure points .

It is estimated that 40% of population is infected with HPV, and in 7% to 12%, a wart develops . Plantar warts exhibit an annual incidence of 14% in the general population . Sixty-five percent to 78% of cutaneous warts have been shown to regress within 2 years . In persons older than 12 years, the rate of spontaneous regression significantly decreases .

Variable therapeutic options are available for treating warts, with none considered a gold standard. Primary treatments include topical salicylic acid, topical imiquimod, topical 5-fluorouracil, cryotherapy, excision, electrocautry and laser vaporization .

Vitamin D is a fat-soluble steroid prohormone that has wide range of biological actions e.g. inhibition of cellular proliferation, induction of terminal differentiation, and inhibition of angiogenesis. It also stimulates macrophages and cathelicidin production . Recently, several studies have demonstrated the efficacy of intralesional vitamin D in treatment of warts, as well as recalcitrant lesions, with clearance rates of 72.5%-90% .

Acyclovir is a synthetic purine nucleoside analogue with activity against some viruses as herpes simplex and varicella-zoster virus. Acyclovir uses viral thymidine kinase to convert to its active form, acyclovir triphosphate. Through this mechanism of utilizing viral thymidine kinase, acyclovir specifically targets viral DNA preventing its replication in the host.

Previously, few studies and case reports documented the clearance of warts, some were unresponsive to prior treatment, with both topical and oral use of acyclovir .

A recent study has evaluated the efficacy of intralesional acyclovir versus intralesional saline in treatment of warts and reported complete clearance rate of 52.6% and a partial response of 16.7% for acyclovir with a statistically significant difference from saline (0% complete clearance) .

Conditions

Plantar Wart

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group 1

this group will be intralesionaly injected with vitamin D3

Group Type: ACTIVE_COMPARATOR

Vitamin D

Intervention Type: 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 2

this group will be intralesionally injected with acyclovir

Group Type: ACTIVE_COMPARATOR

acyclovir

Intervention Type: 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

Interventions

Vitamin D

• 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

Intervention Type: DRUG

acyclovir

-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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• - 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

maha mostafa ali mostafa

Resident physician of Dermatology, Venereology and Andrology, kom Ombo central hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

maha m mostafa, MD

Role: PRINCIPAL_INVESTIGATOR

Assuit University faculty of medicine

Locations

Assuit University

Asyut, , Egypt

Countries

Egypt

Central Contacts

maha m mostafa, MD

Role: CONTACT

mahamostafaali@yahoo.com

+201158597040 ext. a

maha m mostafa, MD

Role: CONTACT

mahamostafaali@yahoo.com

01158597040 ext. a

Other Identifiers

vitamin D3, acyclovir in warts

Identifier Type: -

Identifier Source: org_study_id