WartsNCT05300009
Efficacy and Safety of Topical Methotrexate Gel 1% Coupled With Microneedling in Treatment of Warts
A study testing topical methotrexate hydrogel 1% coupled with microneedling. and Liquid nitrogen in people with Warts, run by Assiut University.
Trial summary
To study the clinical efficacy of the topically applied MTX hydrogel preparation combined with microneedling to increase drug delivery and efficacy in comparison with cryotherapy in treatment of warts. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Warts
- What is being tested?
- topical methotrexate hydrogel 1% coupled with microneedling. and Liquid nitrogen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2022to 15 Aug 2023
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients older than 18 years up to 60 years old.
- Patients with plantar or common warts.
Who cannot join
- pregnancy and lactation
- immunosuppression or being under any kind of treatment causing absolute or relative immunosuppression.
- history of any bleeding, clotting disorder or using anticoagulants.
- chronic systemic diseases such as chronic renal failure, hepatic insufficiency, and cardiovascular disorders.
- concurrent use of systemic or topical treatments of warts .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Topical Methotrexate Gel 1% Coupled With Microneedling in Treatment of Warts : A Prospective Controlled Randomized Trial
To study the clinical efficacy of the topically applied MTX hydrogel preparation combined with microneedling to increase drug delivery and efficacy in comparison with cryotherapy in treatment of warts.
Read the detailed description
Warts are benign proliferation of skin and mucosa caused by the human papilloma virus (HPV). Currently, over 170 HPV types have been identified. Certain HPV types tend to infect skin at anatomical sites, for an example, palmoplantar warts are usually caused by Serotypes 1, 2, and 4; however, warts of any HPV type may occur at any site. Warts are transmitted by direct or indirect contact, and predisposing factors include disruption to the normal epithelial barrier.
There are several modalities for treatment of warts including cryotherapy, electrocoagulation, topical salicylic acid, topical 5-fluorouracil, and laser surgery. All these treatment options can be painful, time-consuming, and/or expensive, and none is considered the gold standard.
Treatments for warts have also included intralesional injections of tuberculin purified protein derivative (PPD), measles, mumps, and rubella vaccine (MMR), and Candida albicans antigen (candidin). This treatment approach is known as intralesional immunotherapy as it is thought that these modalities activate the immune system to recognize the virus, leading to wart clearance
. MTX as an antimetabolite and antifolate drug is a time-tested effective treatment extensively used orally or parenteral in various autoimmune disorders like psoriasis, psoriatic arthritis, alopecia areata, lupus erythematosus, and rheumatoid arthritis in low to moderate doses with good efficacy, safety, and tolerability on a long-term basis
MTX is appropriate for rapidly growing tumors since it inhibits DNA synthesis in actively dividing cells. MTX is a folic acid analog that binds to the dihydrofolate reductase, blocking the formation of tetrahydrofolate and preventing the synthesis of the purine nucleotide thymidine .
Antiviral effect of MTX was observed in the treatment of Zika virus infected cells explaining the antiviral effect of MTX through inhibition of dihydrofolate reductase ..
A literature review shows that intralesional MTX has been successfully used for several indications with no complications reported.
Unlike systemic MXT, topical preparations of the drug, that was adapted for the treatment of localized lesions, showed nonsignificant related hepatotoxic and hematologic adverse effects .
Previous studies used intralesional MTX injection in the treatment of viral warts with different concentrations and revealed that intralesional MTX was less effective in treating plantar warts .
Since MTX is used for various diseases via different routes of administration, the development of novel drug delivery systems to improve its pharmacokinetic properties and targetability is a necessary step for future investigations .
Controlling the burst release and the introduction of new routes of administration would be possible if the drug could be formulated using different delivery systems. Among various drug delivery systems proposed for MTX delivery, great attention has been directed to hydrogels due to their unique and attractive characteristics .
Microneedling is a fine needle that penetrates the skin to induce micro-injuries leading to production of collagen fibers and release of growth factors .
Microneedling has been used as an adjuvant therapy helping a drug delivery and also used in treatment of various dermatologic diseases .
In this study, the investigators chose the hydrogel formulation at a concentration of 1%w/v as a topical MTX form coupled with microneedling to increase the efficacy of methotrexate in treatment of warts. Hydrogel used will be optimized for biocompatibility, consistency and chemical compatibility with methotrexate.
- Conditions
- Warts
- Being tested
- topical methotrexate hydrogel 1% coupled with microneedling., Liquid nitrogen
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical methotrexate hydrogel 1% coupled with microneedling.Combination product
Microneedling will be performed on each wart for a maximum 5 lesions per patient using dermapen (Ostar rechargeable dermapen, OB-DG 03N, Ostar Beauty Sci-Tech Co, Beijing, China) supplied with 12 needles arranged in rows. The penetration depth was adjusted at 2-mm, endpoint was pinpoint bleeding and the dermapen will be held by the hand in a vertical direction on the wart. Then topical methotrexate 1% gel will be applied on the lesions every session.
Liquid nitrogenOther
The wart is frozen for 10 to 30 seconds until a 1- to 2-mm ice ball halo surrounds the targeted area.
The sessions were performed every 2 week until complete clearance for a maximum of six sessions.
| Study group | Role | What they receive |
|---|---|---|
| topical methotrexate hydrogel 1% coupled with microneedling | Experimental | patients who will receive topical methotrexate hydrogel 1% coupled with microneedling Receives: Combination Product: topical methotrexate hydrogel 1% coupled with microneedling. |
| cryotherapy | Active comparator | patients who will receive cryotherapy Receives: Other: Liquid nitrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resolution of all treated wart(s).
Proportion of participants with total remission of wart(s) at the end of the intervention in the two arms of the clinical trial assessed by the investigator and photographic evaluation .
Complete response: responders who show 100% improvement (disappearance of all warts and return to normal skin markings).
Measured: 8 weeks
Partial resolution
Number of subjects achieving partial resolution of treated wart(s) at the end of the intervention in the two arms of the clinical trial assessed by the investigator, photographic evaluation and The following grading system :
Marked response: responders who show 76 to 99% decrease in number and/or decrease in apparent size, as assessed by a clinician and photographic evaluation also known as near-complete response.
Moderate response: partial responders show 25 to 75% improvement. No or minimal response: less than 25% decrease in size/numbers of all warts. the stud
Measured: 8 weeks
Incidence of adverse events
Proportion of participants that developed a serious side effect in the two arms during the clinical trial.
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 Mar 2022
- Study start15 Jun 2022 (estimated)
- Primary completion15 Jun 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khulood Fadhl Ahmed Alhakami, Assiut University
- Investigators
- Khulood F Alhakami, M.B.B.CH, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300009
- Sponsor's protocol ID
- MGMW
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghittoni R, Accardi R, Chiocca S, Tommasino M. Role of human papillomaviruses in carcinogenesis. Ecancermedicalscience. 2015 Apr 29;9:526. doi: 10.3332/ecancer.2015.526. eCollection 2015.
PubMed 25987895Kimura U, Takeuchi K, Kinoshita A, Takamori K, Suga Y. Long-pulsed 1064-nm neodymium:yttrium-aluminum-garnet laser treatment for refractory warts on hands and feet. J Dermatol. 2014 Mar;41(3):252-7. doi: 10.1111/1346-8138.12411. Epub 2014 Feb 10.
PubMed 24506821Shaheen MA, Salem SA, Fouad DA, El-Fatah AA. Intralesional tuberculin (PPD) versus measles, mumps, rubella (MMR) vaccine in treatment of multiple warts: a comparative clinical and immunological study. Dermatol Ther. 2015 Jul-Aug;28(4):194-200. doi: 10.1111/dth.12230. Epub 2015 Apr 6.
PubMed 25847793Sung JY, Hong JH, Kang HS, Choi I, Lim SD, Lee JK, Seok JH, Lee JH, Hur GM. Methotrexate suppresses the interleukin-6 induced generation of reactive oxygen species in the synoviocytes of rheumatoid arthritis. Immunopharmacology. 2000 Apr;47(1):35-44. doi: 10.1016/s0162-3109(99)00185-x.
PubMed 10708808Cipriani P, Ruscitti P, Carubbi F, Liakouli V, Giacomelli R. Methotrexate: an old new drug in autoimmune disease. Expert Rev Clin Immunol. 2014 Nov;10(11):1519-30. doi: 10.1586/1744666X.2014.962996. Epub 2014 Sep 22.
PubMed 25245537Beck S, Zhu Z, Oliveira MF, Smith DM, Rich JN, Bernatchez JA, Siqueira-Neto JL. Mechanism of Action of Methotrexate Against Zika Virus. Viruses. 2019 Apr 10;11(4):338. doi: 10.3390/v11040338.
PubMed 30974762Duarte AA, Carneiro GP, Murari CM, Jesus LCB. Nail psoriasis treated with intralesional methotrexate infiltration. An Bras Dermatol. 2019 Oct 17;94(4):491-492. doi: 10.1590/abd1806-4841.20198170. eCollection 2019. No abstract available.
PubMed 31644634Sutton L, Swinehart JM, Cato A, Kaplan AS. A clinical study to determine the efficacy and safety of 1% methotrexate/Azone (MAZ) gel applied topically once daily in patients with psoriasis vulgaris. Int J Dermatol. 2001 Jul;40(7):464-7. doi: 10.1046/j.1365-4362.2001.01244.x. No abstract available.
PubMed 11679005Abdo HM, Elrewiny EM, Elkholy MS, Ibrahim SM. Efficacy of intralesional methotrexate in the treatment of plantar warts. Dermatol Ther. 2020 Mar;33(2):e13228. doi: 10.1111/dth.13228. Epub 2020 Jan 29.
PubMed 31965678Dehshahri A, Kumar A, Madamsetty VS, Uzieliene I, Tavakol S, Azedi F, Fekri HS, Zarrabi A, Mohammadinejad R, Thakur VK. New Horizons in Hydrogels for Methotrexate Delivery. Gels. 2020 Dec 30;7(1):2. doi: 10.3390/gels7010002.
PubMed 33396629Badran MM, Kuntsche J, Fahr A. Skin penetration enhancement by a microneedle device (Dermaroller) in vitro: dependency on needle size and applied formulation. Eur J Pharm Sci. 2009 Mar 2;36(4-5):511-23. doi: 10.1016/j.ejps.2008.12.008. Epub 2008 Dec 25.
PubMed 19146954Ita K. Dissolving microneedles for transdermal drug delivery: Advances and challenges. Biomed Pharmacother. 2017 Sep;93:1116-1127. doi: 10.1016/j.biopha.2017.07.019. Epub 2017 Jul 19.
PubMed 28738520
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical Methotrexate Gel 1% Coupled With Microneedling in Treatment of Warts : A Prospective Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT05300009
- Acronym / sponsor ID
- MGMW
- Conditions
- Warts
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (estimated)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 29 Mar 2022 (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.
To study the clinical efficacy of the topically applied MTX hydrogel preparation combined with microneedling to increase drug delivery and efficacy in comparison with cryotherapy in treatment of warts.
Detailed description
Warts are benign proliferation of skin and mucosa caused by the human papilloma virus (HPV). Currently, over 170 HPV types have been identified. Certain HPV types tend to infect skin at anatomical sites, for an example, palmoplantar warts are usually caused by Serotypes 1, 2, and 4; however, warts of any HPV type may occur at any site. Warts are transmitted by direct or indirect contact, and predisposing factors include disruption to the normal epithelial barrier.
There are several modalities for treatment of warts including cryotherapy, electrocoagulation, topical salicylic acid, topical 5-fluorouracil, and laser surgery. All these treatment options can be painful, time-consuming, and/or expensive, and none is considered the gold standard.
Treatments for warts have also included intralesional injections of tuberculin purified protein derivative (PPD), measles, mumps, and rubella vaccine (MMR), and Candida albicans antigen (candidin). This treatment approach is known as intralesional immunotherapy as it is thought that these modalities activate the immune system to recognize the virus, leading to wart clearance
. MTX as an antimetabolite and antifolate drug is a time-tested effective treatment extensively used orally or parenteral in various autoimmune disorders like psoriasis, psoriatic arthritis, alopecia areata, lupus erythematosus, and rheumatoid arthritis in low to moderate doses with good efficacy, safety, and tolerability on a long-term basis
MTX is appropriate for rapidly growing tumors since it inhibits DNA synthesis in actively dividing cells. MTX is a folic acid analog that binds to the dihydrofolate reductase, blocking the formation of tetrahydrofolate and preventing the synthesis of the purine nucleotide thymidine .
Antiviral effect of MTX was observed in the treatment of Zika virus infected cells explaining the antiviral effect of MTX through inhibition of dihydrofolate reductase ..
A literature review shows that intralesional MTX has been successfully used for several indications with no complications reported.
Unlike systemic MXT, topical preparations of the drug, that was adapted for the treatment of localized lesions, showed nonsignificant related hepatotoxic and hematologic adverse effects .
Previous studies used intralesional MTX injection in the treatment of viral warts with different concentrations and revealed that intralesional MTX was less effective in treating plantar warts .
Since MTX is used for various diseases via different routes of administration, the development of novel drug delivery systems to improve its pharmacokinetic properties and targetability is a necessary step for future investigations .
Controlling the burst release and the introduction of new routes of administration would be possible if the drug could be formulated using different delivery systems. Among various drug delivery systems proposed for MTX delivery, great attention has been directed to hydrogels due to their unique and attractive characteristics .
Microneedling is a fine needle that penetrates the skin to induce micro-injuries leading to production of collagen fibers and release of growth factors .
Microneedling has been used as an adjuvant therapy helping a drug delivery and also used in treatment of various dermatologic diseases .
In this study, the investigators chose the hydrogel formulation at a concentration of 1%w/v as a topical MTX form coupled with microneedling to increase the efficacy of methotrexate in treatment of warts. Hydrogel used will be optimized for biocompatibility, consistency and chemical compatibility with methotrexate.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| topical methotrexate hydrogel 1% coupled with microneedling | Experimental | Combination Product: topical methotrexate hydrogel 1% coupled with microneedling.patients who will receive topical methotrexate hydrogel 1% coupled with microneedling |
| cryotherapy | Active comparator | Other: Liquid nitrogenpatients who will receive cryotherapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients older than 18 years up to 60 years old.
- Patients with plantar or common warts.
Key exclusion criteria (5 listed)
- pregnancy and lactation
- immunosuppression or being under any kind of treatment causing absolute or relative immunosuppression.
- history of any bleeding, clotting disorder or using anticoagulants.
- chronic systemic diseases such as chronic renal failure, hepatic insufficiency, and cardiovascular disorders.
- concurrent use of systemic or topical treatments of warts .
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 |
|---|---|---|
| topical methotrexate hydrogel 1% coupled with microneedling.Microneedling will be performed on each wart for a maximum 5 lesions per patient using dermapen (Ostar rechargeable dermapen, OB-DG 03N, Ostar Beauty Sci-Tech Co, Beijing, China) supplied with 12 needles arranged in rows. The penetration depth was adjusted at 2-mm, endpoint was pinpoint bleeding and the dermapen will be held by the hand in a vertical direction on the wart. Then topical methotrexate 1% gel will be applied on the lesions every session. | Combination product | topical methotrexate hydrogel 1% coupled with microneedling |
| Liquid nitrogenThe wart is frozen for 10 to 30 seconds until a 1- to 2-mm ice ball halo surrounds the targeted area. The sessions were performed every 2 week until complete clearance for a maximum of six sessions. | Other | cryotherapy |
Primary outcome
Complete resolution of all treated wart(s).
Time frame: 8 weeks
Proportion of participants with total remission of wart(s) at the end of the intervention in the two arms of the clinical trial assessed by the investigator and photographic evaluation . Complete response: responders who show 100% improvement (disappearance of all warts and return to normal skin markings).
Partial resolution
Time frame: 8 weeks
Number of subjects achieving partial resolution of treated wart(s) at the end of the intervention in the two arms of the clinical trial assessed by the investigator, photographic evaluation and The following grading system : Marked response: responders who show 76 to 99% decrease in number and/or decrease in apparent size, as assessed by a clinician and photographic evaluation also known as near-complete response. Moderate response: partial responders show 25 to 75% improvement. No or minimal response: less than 25% decrease in size/numbers of all warts. the stud
Incidence of adverse events
Time frame: 8 weeks
Proportion of participants that developed a serious side effect in the two arms during the clinical trial.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Background: PubMed 25987895Ghittoni R, Accardi R, Chiocca S, Tommasino M. Role of human papillomaviruses in carcinogenesis. Ecancermedicalscience. 2015 Apr 29;9:526. doi: 10.3332/ecancer.2015.526. eCollection 2015.
- Background: PubMed 24506821Kimura U, Takeuchi K, Kinoshita A, Takamori K, Suga Y. Long-pulsed 1064-nm neodymium:yttrium-aluminum-garnet laser treatment for refractory warts on hands and feet. J Dermatol. 2014 Mar;41(3):252-7. doi: 10.1111/1346-8138.12411. Epub 2014 Feb 10.
- Background: PubMed 25847793Shaheen MA, Salem SA, Fouad DA, El-Fatah AA. Intralesional tuberculin (PPD) versus measles, mumps, rubella (MMR) vaccine in treatment of multiple warts: a comparative clinical and immunological study. Dermatol Ther. 2015 Jul-Aug;28(4):194-200. doi: 10.1111/dth.12230. Epub 2015 Apr 6.
- Background: PubMed 10708808Sung JY, Hong JH, Kang HS, Choi I, Lim SD, Lee JK, Seok JH, Lee JH, Hur GM. Methotrexate suppresses the interleukin-6 induced generation of reactive oxygen species in the synoviocytes of rheumatoid arthritis. Immunopharmacology. 2000 Apr;47(1):35-44. doi: 10.1016/s0162-3109(99)00185-x.
- Background: PubMed 25245537Cipriani P, Ruscitti P, Carubbi F, Liakouli V, Giacomelli R. Methotrexate: an old new drug in autoimmune disease. Expert Rev Clin Immunol. 2014 Nov;10(11):1519-30. doi: 10.1586/1744666X.2014.962996. Epub 2014 Sep 22.
- Background: PubMed 30974762Beck S, Zhu Z, Oliveira MF, Smith DM, Rich JN, Bernatchez JA, Siqueira-Neto JL. Mechanism of Action of Methotrexate Against Zika Virus. Viruses. 2019 Apr 10;11(4):338. doi: 10.3390/v11040338.
- Background: PubMed 31644634Duarte AA, Carneiro GP, Murari CM, Jesus LCB. Nail psoriasis treated with intralesional methotrexate infiltration. An Bras Dermatol. 2019 Oct 17;94(4):491-492. doi: 10.1590/abd1806-4841.20198170. eCollection 2019. No abstract available.
- Background: PubMed 11679005Sutton L, Swinehart JM, Cato A, Kaplan AS. A clinical study to determine the efficacy and safety of 1% methotrexate/Azone (MAZ) gel applied topically once daily in patients with psoriasis vulgaris. Int J Dermatol. 2001 Jul;40(7):464-7. doi: 10.1046/j.1365-4362.2001.01244.x. No abstract available.
- Background: PubMed 31965678Abdo HM, Elrewiny EM, Elkholy MS, Ibrahim SM. Efficacy of intralesional methotrexate in the treatment of plantar warts. Dermatol Ther. 2020 Mar;33(2):e13228. doi: 10.1111/dth.13228. Epub 2020 Jan 29.
- Background: PubMed 33396629Dehshahri A, Kumar A, Madamsetty VS, Uzieliene I, Tavakol S, Azedi F, Fekri HS, Zarrabi A, Mohammadinejad R, Thakur VK. New Horizons in Hydrogels for Methotrexate Delivery. Gels. 2020 Dec 30;7(1):2. doi: 10.3390/gels7010002.
- Background: PubMed 19146954Badran MM, Kuntsche J, Fahr A. Skin penetration enhancement by a microneedle device (Dermaroller) in vitro: dependency on needle size and applied formulation. Eur J Pharm Sci. 2009 Mar 2;36(4-5):511-23. doi: 10.1016/j.ejps.2008.12.008. Epub 2008 Dec 25.
- Background: PubMed 28738520Ita K. Dissolving microneedles for transdermal drug delivery: Advances and challenges. Biomed Pharmacother. 2017 Sep;93:1116-1127. doi: 10.1016/j.biopha.2017.07.019. Epub 2017 Jul 19.
- Individual participant dataSharing planned: No
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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.
Khulood F Alhakami, M.B.B.CH principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing topical methotrexate hydrogel 1% coupled with microneedling. and Liquid nitrogen in people with Warts, run by Assiut University.
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 2 inclusion and 5 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 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Eman R Mohamed, Professor (+201005298992, e_riad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete resolution of all treated wart(s). (time frame: 8 weeks). 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 NCT05300009, which also lists 12 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 29 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.