Intralesional Acyclovir Versus Intralesional Zinc Sulphate in the Treatment of Plantar Warts

NCT07848100 | Not Yet Recruiting Phase 3

• 1 other identifier: PlantarWarts-RCT-2026
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical trial aims to compare the efficacy and safety of intralesional acyclovir versus intralesional zinc sulphate in the treatment of plantar warts.

Conditions

Warts; Plantar Warts; Human Papillomavirus Infection; Skin Diseases, Viral

Keywords

Plantar Warts; Intralesional Acyclovir; Intralesional Zinc Sulphate; Dermoscopy; Human Papillomavirus; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Clinical Response of the Injected Warts

  Clinical response assessed by standardized digital photographs and dermoscopic evaluation. Response will be graded using scoring system : Score 0: neither clinical nor dermoscopic response. Score 1: clinical improvement without dermoscopic clearance. Score 2: clinical disappearance with dermoscopic evidence of residual wart tissue. Score 3: complete clinical and dermoscopic clearance with return of normal skin markings.

  8 weeks

Study Arms (2)

Intralesional Acyclovir

ACTIVE COMPARATOR

This group will receive intralesional acyclovir

Drug: Intralesional Acyclovir

Intralesional Zinc Sulphate

ACTIVE COMPARATOR

This group will receive intralesional zinc sulphate 2%

Drug: Intralesional Zinc Sulphate

Interventions

Intralesional Acyclovir DRUG

Intralesional injection of acyclovir, prepared using 250 mg acyclovir vial diluted with 3.5 ml saline (yielding an acyclovir concentration of approximately 70 mg/ml), at a dose of (0.1- 0.3 ml) injected into the largest (target) wart under aseptic precautions using an insulin syringe. The injection will be repeated every 2 weeks until complete clearance of warts or for a maximum of five sessions.

Intralesional Acyclovir

Intralesional Zinc Sulphate DRUG

Intralesional injection of 2% zinc sulphate prepared using 2 gm of zinc sulphate powder dissolved in 100 ml of sterile distilled water and autoclaved at 95°C for 20 minutes, at a dose of (0.1- 0.3 ml) in the base of the largest (target) wart . The wart is injected with the solution till blanching or bleb formation. Subcutaneous injections and acral parts such as fingers and toes will be avoided, as it may cause vascular necrosis. Injections will be repeated for all patients into the same lesion every 2 weeks until complete clearance of warts or for a maximum of five sessions.

Intralesional Zinc Sulphate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18-50 years of both sexes clinically diagnosed with multiple plantar warts.

You may not qualify if:

• Patients with wart types other than plantar warts (genital, common, and plane warts).
• Pregnant or lactating women.
• Immunocompromised patients.
• Individuals receiving systemic immunosuppressive or antiviral therapy.
• History of hypersensitivity to acyclovir or zinc compounds.
• Patients with current acute febrile illness or any bacterial infection.
• Receiving any treatment for warts within 1 month before the study.
• Concurrent other skin disorders.
• Patients with systemic diseases (liver or renal disease, bleeding disorders).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• Barkat MT, Abdel-Aziz RTA, Mohamed MS. Evaluation of intralesional injection of bleomycin in the treatment of plantar warts: clinical and dermoscopic evaluation. Int J Dermatol. 2018 Dec;57(12):1533-1537. doi: 10.1111/ijd.14092. Epub 2018 Jun 15.

  PMID: 29907964 BACKGROUND

• Youssef EMK, Eissa MAA, Bakr RM. Intralesional Candida albicans antigen versus intralesional zinc sulfate in treatment of cutaneous warts. Arch Dermatol Res. 2023 Jul;315(5):1305-1314. doi: 10.1007/s00403-022-02499-w. Epub 2022 Dec 26.

  PMID: 36567351 BACKGROUND

• Mohamed EE, Tawfik KM, Mahmoud AM. The Clinical Effectiveness of Intralesional Injection of 2% Zinc Sulfate Solution in the Treatment of Common Warts. Scientifica (Cairo). 2016;2016:1082979. doi: 10.1155/2016/1082979. Epub 2016 Mar 31.

  PMID: 27123361 BACKGROUND

• Gharib K, Taha A, Elradi M. Intralesional acyclovir versus intralesional Hepatitis-B vaccine in treatment of resistant plantar warts: a randomized controlled trial. Arch Dermatol Res. 2024 Jun 1;316(6):325. doi: 10.1007/s00403-024-03001-4.

  PMID: 38822848 BACKGROUND

• Mullen SA, Myers EL, Brenner RL, Nguyen KT, Harper TA, Welsh D, Keffer S, Mueller J, Whitley MJ. Systematic Review of Intralesional Therapies for Cutaneous Warts. JID Innov. 2024 Jan 24;4(3):100264. doi: 10.1016/j.xjidi.2024.100264. eCollection 2024 May.

  PMID: 38585192 BACKGROUND

• Al Aboud AM, Nigam PK. Wart. 2023 Aug 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK431047/

  PMID: 28613701 BACKGROUND

MeSH Terms

Conditions

Warts; Papillomavirus Infections; Skin Diseases, Viral

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dalia A Attallah, Professor

  Dermatology Department Assiut University Hospital, Assiut, Egypt

  STUDY DIRECTOR

• Radwa M Bakr, Assistant Professor

  Dermatology Department Assiut University Hospital, Assiut, Egypt

  STUDY DIRECTOR

Central Study Contacts

Silvana S Shawky, Resident

CONTACT

01099029774; Silvana.18313420@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Department of Dermatology

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share