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

Sohag University

Status and phase: Enrolling; Phase 4

Conditions: Acyclovir and Candida Antigen in Treatment of Plantar Wart

Treatments: Drug: Acyclovir 250mg Powder for Solution for Infusion, each vial contains 250mg of acyclovir as the sodium salt, Chandra Bhagat Pharma Pvt. Ltd andcandida antigen

Study type: Interventional

Funder types: Other

Identifiers

NCT05429151

Soh-Med-22-06-06

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The study will include patients with single or multiple planter wart. Age group 18:50 years old

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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40 participants in 2 patient groups

group 1

Active Comparator group

Description:

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

Treatment:

Drug: Acyclovir 250mg Powder for Solution for Infusion, each vial contains 250mg of acyclovir as the sodium salt, Chandra Bhagat Pharma Pvt. Ltd andcandida antigen

group 2

Active Comparator group

Description:

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.

Treatment:

Drug: Acyclovir 250mg Powder for Solution for Infusion, each vial contains 250mg of acyclovir as the sodium salt, Chandra Bhagat Pharma Pvt. Ltd andcandida antigen