Clinical trial NCT05324904: Intralesional Vitamin D3 Versus Intralesional Acyclovir in Treatment of Plantar Warts
Official title: Intralesional Vitamin D3 Versus Intralesional Acyclovir in Treatment of Plantar Warts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plantar Wart
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 44
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) .

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.

Primary outcomes:
measure: complete healing rate
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University
Study officials:
affiliation: Assuit University faculty of medicine
name: maha m mostafa, MD
role: PRINCIPAL_INVESTIGATOR
References: