Intralesional Vitamin D3 Versus Intralesional Acyclovir in Treatment of Plantar Warts
Primary Purpose
Plantar Wart
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D
acyclovir
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Wart
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.
Sites / Locations
- Assuit University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group 1
group 2
Arm Description
this group will be intralesionaly injected with vitamin D3
this group will be intralesionally injected with acyclovir
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05324904
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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) .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Wart
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Active Comparator
Arm Description
this group will be intralesionaly injected with vitamin D3
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
this group will be intralesionally injected with acyclovir
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
- 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
Intervention Name(s)
acyclovir
Intervention Description
-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
Primary Outcome Measure Information:
Title
complete healing rate
Description
Main outcome variable is the complete healing rate among planter warts patients treated with intralesional vitamin D3 compared to those by Intralesional acyclovir
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
maha m mostafa, MD
Phone
+201158597040
Ext
a
Email
mahamostafaali@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
maha m mostafa, MD
Phone
01158597040
Ext
a
Email
mahamostafaali@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
maha m mostafa, MD
Organizational Affiliation
Assuit University faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assuit University
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Intralesional Vitamin D3 Versus Intralesional Acyclovir in Treatment of Plantar Warts
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