Plantar WartPhase 2/3NCT06261684
Intralesional Acyclovir Versus Cryotherapy in the Treatment of Plantar Warts. A Randomized Controlled Trial.
A Phase 2/3 study testing Intralesional Acyclovir and Cryotherapy in people with Plantar Wart, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this prospective randomized controlled study is to study the safety and efficacy of intralesional acyclovir compared to cryotherapy in plantar warts. The main questions needed to be answered are: 1. Is Intralesional acyclovir safe for plantar warts? 2. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plantar Wart
- What is being tested?
- Intralesional Acyclovir and Cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Oct 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older, of both genders, with plantar warts
Who cannot join
- Patients on systemic treatment for warts eg. Acitretin, Acyclovir
- Hypersensitivity to Acyclovir
- Previous treatment to the same wart during the last 3 months
- Immunocompromised patients (as HIV, steroid intake, uncontrolled diabetes, etc.)
- Pregnant and breastfeeding females
- Cognitively impaired patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Hospital
Cairo
Basant Helal, MRCP
Shahira Ramadan, Professor
About this study
The goal of this prospective randomized controlled study is to study the safety and efficacy of intralesional acyclovir compared to cryotherapy in plantar warts. The main questions needed to be answered are:
- Is Intralesional acyclovir safe for plantar warts?
- Is Intralesional acyclovir more efficient in treating plantar warts compared to cryotherapy?
- Conditions
- Plantar Wart
- Being tested
- Intralesional Acyclovir, Cryotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional AcyclovirDrug
Intralesional Acyclovir in plantar warts
CryotherapyDevice
Cryotherapy of plantar warts
| Study group | Role | What they receive |
|---|---|---|
| Intralesional Acyclovir | Experimental | Intralesional acyclovir will be prepared by diluting 1 ampoule of Acyclovir 250mg into 3.5ml of saline solution to achieve a concentration of approximately 70mg/ml. Then 0.1ml will be injected intra-lesionally into the base of the wart. Any hyperkeratotic lesions should be pared before the treatment. This process will be repeated every 2 weeks for 5 sessions, and can be discontinued if complete resolution is achieved early. Receives: Drug: Intralesional Acyclovir |
| Cryotherapy | Active comparator | Patients allocated to Group B will undergo cryotherapy using a liquid nitrogen spray gun. Any hyperkeratotic lesions should be pared before the treatment. Two freeze-thaw cycles will be applied each session, the spray gun should be held 1cm away from the wart and maintained until the wart and the 1-3mm of surrounding skin shows freezing, and each cycle should last 15 seconds. Next, the lesion will be left to thaw completely before starting the second cycle. This process will be repeated every 2 weeks for 5 sessions, and can be discontinued if complete resolution is achieved early Receives: Device: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate
Number of patients healed after completion of the sessions
Measured: 10 weeks (5 sessions max)
Recurrence rate
Number of patients had recurred plantar warts after receiving the treatment
Measured: 24 weeks
Patient satisfaction score
Patient satisfaction questionnaire score
Measured: 10 weeks
Secondary outcomes (4)
Correlation of treatment with number of ipsilateral warts
Number of warts increased, decreased or stationary
Measured: 10 weeks
Correlation of treatment with age
Percentage of patients successfully treated in each age group (Young 18-32 years; Middle age 33-46, Old age 47-60
Measured: 10 weeks
Correlation of treatment with gender
Percentage of successfully treated male to female patients
Measured: 10 weeks
Correlation of treatment with size of the wart
Percentage of successful treatment compared to the size of the wart
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Oct 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Plantar WartStudies of the same condition, open and under way.
- More trials run by Cairo 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basant Ahmed Mohamed Abdelaal Helal, Cairo University
- Investigators
- Shahira Ramadan, Professor, Study chair, Cairo UniversityYousra Azzazi, Lecturer, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261684
- Sponsor's protocol ID
- MS-259-2023
- Status last verified
- Feb 2024
- First submitted
- 6 Oct 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elsayed A, Nassar A, Marei A, Hoseiny HAM, Alakad R. Intralesional Acyclovir: A Potential Therapeutic Option for Cutaneous Warts. J Cutan Med Surg. 2022 Jan-Feb;26(1):25-30. doi: 10.1177/12034754211037998. Epub 2021 Aug 19.
PubMed 34412535Garcia-Oreja S, Alvaro-Afonso FJ, Tardaguila-Garcia A, Lopez-Moral M, Garcia-Madrid M, Lazaro-Martinez JL. Efficacy of cryotherapy for plantar warts: A systematic review and meta-analysis. Dermatol Ther. 2022 Jun;35(6):e15480. doi: 10.1111/dth.15480. Epub 2022 Apr 6.
PubMed 35365922
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralesional Acyclovir Versus Cryotherapy in the Treatment of Plantar Warts. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06261684
- Acronym / sponsor ID
- MS-259-2023
- Conditions
- Plantar Wart
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective randomized controlled study is to study the safety and efficacy of intralesional acyclovir compared to cryotherapy in plantar warts. The main questions needed to be answered are:
- Is Intralesional acyclovir safe for plantar warts?
- Is Intralesional acyclovir more efficient in treating plantar warts compared to cryotherapy?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralesional Acyclovir | Experimental | Drug: Intralesional AcyclovirIntralesional acyclovir will be prepared by diluting 1 ampoule of Acyclovir 250mg into 3.5ml of saline solution to achieve a concentration of approximately 70mg/ml. Then 0.1ml will be injected intra-lesionally into the base of the wart. Any hyperkeratotic lesions should be pared before the treatment. This process will be repeated every 2 weeks for 5 sessions, and can be discontinued if complete resolution is achieved early. |
| Cryotherapy | Active comparator | Device: CryotherapyPatients allocated to Group B will undergo cryotherapy using a liquid nitrogen spray gun. Any hyperkeratotic lesions should be pared before the treatment. Two freeze-thaw cycles will be applied each session, the spray gun should be held 1cm away from the wart and maintained until the wart and the 1-3mm of surrounding skin shows freezing, and each cycle should last 15 seconds. Next, the lesion will be left to thaw completely before starting the second cycle. This process will be repeated every 2 weeks for 5 sessions, and can be discontinued if complete resolution is achieved early |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 years or older, of both genders, with plantar warts
Key exclusion criteria (6 listed)
- Patients on systemic treatment for warts eg. Acitretin, Acyclovir
- Hypersensitivity to Acyclovir
- Previous treatment to the same wart during the last 3 months
- Immunocompromised patients (as HIV, steroid intake, uncontrolled diabetes, etc.)
- Pregnant and breastfeeding females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intralesional AcyclovirIntralesional Acyclovir in plantar warts | Drug | Intralesional Acyclovir |
| CryotherapyCryotherapy of plantar warts | Device | Cryotherapy |
Primary outcome
Cure rate
Time frame: 10 weeks (5 sessions max)
Number of patients healed after completion of the sessions
Recurrence rate
Time frame: 24 weeks
Number of patients had recurred plantar warts after receiving the treatment
Patient satisfaction score
Time frame: 10 weeks
Patient satisfaction questionnaire score
4 secondary outcomes
Correlation of treatment with number of ipsilateral warts
Time frame: 10 weeks
Correlation of treatment with age
Time frame: 10 weeks
Correlation of treatment with gender
Time frame: 10 weeks
Correlation of treatment with size of the wart
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 34412535Elsayed A, Nassar A, Marei A, Hoseiny HAM, Alakad R. Intralesional Acyclovir: A Potential Therapeutic Option for Cutaneous Warts. J Cutan Med Surg. 2022 Jan-Feb;26(1):25-30. doi: 10.1177/12034754211037998. Epub 2021 Aug 19.
- Background: PubMed 35365922Garcia-Oreja S, Alvaro-Afonso FJ, Tardaguila-Garcia A, Lopez-Moral M, Garcia-Madrid M, Lazaro-Martinez JL. Efficacy of cryotherapy for plantar warts: A systematic review and meta-analysis. Dermatol Ther. 2022 Jun;35(6):e15480. doi: 10.1111/dth.15480. Epub 2022 Apr 6.
- Individual participant dataSharing planned: No
Related trials for Plantar Wart
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Intralesional Acyclovir Versus Intralesional Zinc Sulphate in the Treatment of Plantar Warts
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Hydrogen Peroxide 40% Versus Salicylic Acid 40% for Plantar Warts
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Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts
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RecruitingPhase 4
Intralesional Therapies For Cutaneous Viral Warts: A Comparative Analysis Of Vitamin D3 And Acyclovir
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahira Ramadan, Professor study chair
Cairo University
Yousra Azzazi, Lecturer study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intralesional Acyclovir and Cryotherapy in people with Plantar Wart, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Basant Helal, MRCP (+201144166922, basant_helal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate (time frame: 10 weeks (5 sessions max)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06261684, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.