WartsPhase 3NCT07848100
Intralesional Acyclovir Versus Intralesional Zinc Sulphate in the Treatment of Plantar Warts
A Phase 3 study testing Intralesional Acyclovir and Intralesional Zinc Sulphate in people with Warts and Plantar Warts, run by Assiut University.
Trial summary
This clinical trial aims to compare the efficacy and safety of intralesional acyclovir versus intralesional zinc sulphate in the treatment of plantar warts. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Warts, Plantar Warts, Human Papillomavirus Infection
- What is being tested?
- Intralesional Acyclovir and Intralesional Zinc Sulphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Mar 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-50 years of both sexes clinically diagnosed with multiple plantar warts.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This clinical trial aims to compare the efficacy and safety of intralesional acyclovir versus intralesional zinc sulphate in the treatment of plantar warts.
Read the detailed description
Viral warts represent benign epidermal proliferations associated with human papillomavirus (HPV) infection. HPV is a double-stranded DNA virus with more than 150 identified types, several of which have a predilection for cutaneous tissues and can produce distinct clinical forms of warts. Transmission occurs through direct skin-to-skin contact, indirect contact with contaminated surfaces, or autoinoculation, as when a wart is scratched or picked and virus is carried to a new site.
Cutaneous warts occur worldwide, with an estimated overall population prevalence of roughly 10%, rising to 10-20% among school-aged children. Although warts may develop at any age, incidence climbs through childhood and peaks between 12 and 16 years. Most lesions are asymptomatic, but they are not without consequence: warts can produce cosmetic disfigurement and psychosocial distress, and those on weight-bearing surfaces such as the plantar skin can become painful with walking or pressure. The principal clinical types are common, plantar, plane, filiform, and genital warts.
Plantar warts, the focus of the present study, arise on the sole and are most commonly attributed to HPV types 1, 2, 4, 27 and 57. Because of the constant pressure exerted by weight-bearing, these lesions tend to grow inward rather than outward and are often covered by a thick overlying callus that can mask the lesion and delay diagnosis; adjacent warts may also coalesce into a mosaic pattern. Unlike many other cutaneous warts, plantar warts are frequently symptomatic, producing a sharp, well-localized pain on walking or standing that can meaningfully impair mobility and daily activities. Clinically, they are distinguished from corns and calluses by the presence of pinpoint black dots, corresponding to thrombosed dermal capillaries, and by interruption of the normal skin lines across the lesion.
Several therapeutic modalities are available for cutaneous warts, including destructive methods such as salicylic acid, cryotherapy, silver nitrate, electrosurgery and pulsed-dye laser, antiproliferative agents such as formaldehyde, vitamin D3, bleomycin, 5-fluorouracil, podophyllin and podophyllotoxin, topical immunological agents such as imiquimod ; However, treatment remains challenging because of variable efficacy, prolonged treatment courses, recurrence and adverse effects. No single treatment option is considered gold standard.
Intralesional therapies are an emerging and effective approach for treating recalcitrant warts. Several immunotherapeutic agents for warts including vitamin D3; tuberculin purified protein derivative (PPD); Candida antigen (Candida); the measles, mumps, rubella (MMR) vaccine, BCG, zinc sulphate and antivirals such as acyclovir have demonstrated variable complete response rates in randomized controlled trials. Unlike various other treatment options, immunotherapeutic approaches upregulate the immune system to recognize and destroy the lesions at both the target site and distant locations.
Acyclovir, a synthetic purine nucleoside analogue, is active against herpes simplex virus (HSV) and varicella-zoster virus (VZV) through a selective activation pathway: viral thymidine kinase first converts the drug to its monophosphate form, after which host-cell enzymes complete its conversion to the active triphosphate metabolite. This triphosphate form competitively blocks viral DNA polymerase and, once incorporated into the elongating viral DNA strand, halts further chain extension, thereby arresting viral DNA synthesis.
Acyclovir is considered an evolving treatment option for warts; however, its mechanism of action against HPV is not fully understood. In a recent randomized controlled trial, intralesional acyclovir (70 mg/ml) was injected at a dose of 0.1 ml using an insulin syringe into each of the largest three warts (total 0.3 ml per session), repeated every 2 weeks until complete clearance or for a maximum of five sessions, resulting in a complete response rate of 37.5%.
The therapeutic effect of zinc sulphate in warts is thought to reflect a combination of direct local cytotoxicity and immune stimulation. Following intralesional injection, it triggers a localized inflammatory cascade in which eosinophils arrive first, followed sequentially by lymphocytes and fibroblasts, which may help drive immune-mediated clearance of HPV-infected keratinocytes. Zinc also contributes to immune regulation by supporting leukocyte and natural killer cell function. However, the precise mechanism by which intralesional zinc sulphate promotes HPV clearance remains incompletely understood.
Zinc sulfate has been investigated as an effective intralesional immunotherapy treatment for warts. A recent randomized controlled study evaluated intralesional 2% zinc sulphate in patients with common, plantar, and plane warts. Zinc sulphate was prepared by dissolving 2 g in 100 ml sterile distilled water and autoclaving at 95°C for 20 minutes. A dose of 0.1 ml was injected into the largest wart until blanching or bleb formation, with treatment repeated for up to six sessions. Complete response was achieved in 68.6% of patients, while complete clearance of the target wart was observed in 74.3% of cases.
Although both agents have demonstrated promising efficacy in the treatment of cutaneous warts, so far, there is no direct comparative study evaluating intralesional acyclovir versus intralesional zinc sulphate. Therefore, the present study aims to provide a direct head to head comparison of the efficacy and safety of intralesional acyclovir versus intralesional zinc sulphate in the treatment of patients with plantar warts.
- Being tested
- Intralesional Acyclovir, Intralesional Zinc Sulphate
- Keywords
- Plantar Warts, Intralesional Acyclovir, Intralesional Zinc Sulphate, Dermoscopy, Human Papillomavirus, Randomized Controlled Trial
- Medical subject headings
- Warts, Papillomavirus Infections, Skin Diseases, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional AcyclovirDrug
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 Zinc SulphateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intralesional Acyclovir | Active comparator | This group will receive intralesional acyclovir Receives: Drug: Intralesional Acyclovir |
| Intralesional Zinc Sulphate | Active comparator | This group will receive intralesional zinc sulphate 2% Receives: Drug: Intralesional Zinc Sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for WartsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvana Saeed Shawky, Assiut University
- Investigators
- Dalia A Attallah, Professor, Study director, Dermatology Department Assiut University Hospital, Assiut, EgyptRadwa M Bakr, Assistant Professor, Study director, Dermatology Department Assiut University Hospital, Assiut, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848100
- Sponsor's protocol ID
- PlantarWarts-RCT-2026
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29907964Youssef 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.
PubMed 36567351Mohamed 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.
PubMed 27123361Gharib 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.
PubMed 38822848Mullen 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.
PubMed 38585192Al 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/
PubMed 28613701