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Intralesional Injection of Acyclovir Versus Candida Antigen in Treatment of Plantar Warts

Registration Number
NCT05429151
Lead Sponsor
Sohag University
Brief Summary

This study aims to evaluate the efficacy of intralesional injection of acyclovir versus candida antigen in plantar wart patients will be randomly divided into 2 groups,At least 20 patients will be enrolled in each group.

Group 1: will be treated with intralesional injection of acyclovir 250 mg acyclovir vial diluted with 3.5 ml saline to get approximately 70 mg/ml solution. The base of each wart was injected with 0.1 ml of intralesional acyclovir (70 mg/ml) every 2 weeks until the resolution of warts or for a maximum of 5 sessions Group 2: will be treated by intralesional Candida antigen injection (candida antigen ) at a dose of 0.2 mL. injected into the largest wart every 2 weeks until complete clearance of warts or for a maximum of 5 treatment sessions.

3.Patient evaluation: Assessment of treatment efficacy and side effects will be carried out by clinical examination and comparative photographic evaluation and dermoscopy

Detailed Description

patients will be randomly divided into 2 groups, group (1) and group (2). At least 20 patients will be enrolled in each group.

Group 1: will be treated with intralesional injection of acyclovir (Acyclovir 250mg Powder for Solution for Infusion, each vial contains 250mg of acyclovir as the sodium salt, Chandra Bhagat Pharma Pvt. Ltd) 250 mg acyclovir vial diluted with 3.5 ml saline to get approximately 70 mg/ml solution. During the study, the dosage of the drug and frequency of treatment were uniform in all patients. The base of each wart was injected with 0.1 ml of intralesional acyclovir (70 mg/ml) using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until the resolution of warts or for a maximum of 5 sessions

Group 2: will be treated by intralesional Candida antigen injection (candida antigen ) at a dose of 0.2 mL. injected into the largest wart using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until complete clearance of warts or for a maximum of 5 treatment sessions.

patients will be followed up for 3months after treatment.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
40
Inclusion Criteria
  • The study will include patients with single or multiple planter wart. Age group 18:50 years old
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Exclusion Criteria
  • : patients with history of renal or liver disease, pregnant and lactating females, patients taking immunosuppressant drugs, patients who received any treatment for wart in the last month before the study.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
group 1Acyclovir 250mg Powder for Solution for Infusion, each vial contains 250mg of acyclovir as the sodium salt, Chandra Bhagat Pharma Pvt. Ltd andcandida antigenwill be treated with intralesional injection of acyclovir (Acyclovir 250mg Powder for Solution for Infusion, each vial contains 250mg of acyclovir as the sodium salt, Chandra Bhagat Pharma Pvt. Ltd) 250 mg acyclovir vial diluted with 3.5 ml saline to get approximately 70 mg/ml solution. During the study, the dosage of the drug and frequency of treatment were uniform in all patients. The base of each wart was injected with 0.1 ml of intralesional acyclovir (70 mg/ml) using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until the resolution of warts or for a maximum of 5 sessions
group 2Acyclovir 250mg Powder for Solution for Infusion, each vial contains 250mg of acyclovir as the sodium salt, Chandra Bhagat Pharma Pvt. Ltd andcandida antigenwill be treated by intralesional Candida antigen injection (candida antigen ) at a dose of 0.2 mL. injected into the largest wart using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until complete clearance of warts or for a maximum of 5 treatment sessions.
Primary Outcome Measures
NameTimeMethod
degree of improvment of wart after intralesional injection of acyclovir and candida antigen3months after treatment.

1. complete response: when 100% complete disappearance of the wart.

2. partial response: if there is 50% to 99% reduction in its original diameter.

3. no response: if there reduction in its size \<50% .

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Sohag

🇪🇬

Sohag, Egypt

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