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Common WartPhase 4NCT03183765

Intralesional Measles, Mumps, Rubella (MMR) Vaccine Versus Cryotherapy in Treatment of Multiple Common and Planter Warts

A Phase 4 study testing Measles-Mumps-Rubella Vaccine and cryotherapy in people with Common Wart and Plantar Wart, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Warts are benign epidermal tumors caused by human papilloma virus, which are epitheliotropic non-enveloped double stranded DNA viruses. Transmission of warts occurs from direct person-to-person contact or indirectly by fomites . Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Common Wart, Plantar Wart
What is being tested?
Measles-Mumps-Rubella Vaccine and cryotherapy
Type of treatment
Vaccines, Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteEgypt
Study dates
1 Aug 2017to 1 May 2018
Phase
Phase 4
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients should have multiple common or plantar warts.
  • No concurrent systemic or topical treatment of warts

Who cannot join

  • patients under 16 years old.
  • Patients with fever or signs of any inflammation or infection.
  • Patients with other types of warts.
  • Patients with single warts.
  • Pregnancy.
  • Lactation.
Show all 9Show fewer
  • Immunosuppression.
  • Patients who received any other treatments for their warts in the month before starting study.
  • Past history of asthma, allergic skin disorders, meningitis or convulsions.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut university hospitals

    Asyut, 71515

Other trials in Egypt

About this study

Official title: Intralesional Measles, Mumps, Rubella (MMR) Vaccine Versus Cryotherapy in Treatment of Multiple Common and Planter Warts : a Randomized Controlled Trial

Warts are benign epidermal tumors caused by human papilloma virus, which are epitheliotropic non-enveloped double stranded DNA viruses. Transmission of warts occurs from direct person-to-person contact or indirectly by fomites . Warts appear in various forms including verruca vulgaris, plane, plantar, filiform, digitate and periungual.

Read the detailed description

Treatment of warts is difficult for patients and physicians . Currently Available treatment options include cryosurgery, laser, electrosurgery, bleomycin, and topical keratolytic applications; many of them are painful, ineffective, costly and prone for recurrences.

Cryotherapy, which uses liquid nitrogen to freeze tissues and destroy warts, is one of the most common and effective treatments. freezing causes local irritation, leading the host to mount an immune reaction against the virus.

Immunotherapy appears to enhance virus recognition by immune system; allowing clearance of treated wart, distant warts , and helps to prevent infection .Recently, intralesional immunotherapy using different antigens such as mumps, Candida, and tuberculin has been proved effective in the treatment of warts.

The exact mechanism of action of intralesional immunotherapy is still obscure. Intralesional antigen injection probably induces strong non specific inflammatory response against the human papilloma virus-infected cells.

It has been suggested that intralesional measles mumps rubella vaccine results in regression of warts via induction of immune system.

Being tested
Measles-Mumps-Rubella Vaccine, cryotherapy
Medical subject headings
Warts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Measles-Mumps-Rubella VaccineDrug

    Also called MMR

    MMR vaccine will be injected 0.5 ml into the largest wart at 2-week intervals until complete clearance was achieved or for a maximum of 3 treatments.

    Response to treatment will be evaluated 1 month after the last session by decrease in the size of warts, decrease in the number of warts and photographic comparison. The clinical response was graded into complete (complete cure), partial (if there was a decrease in the size and\or a decrease in the total number of warts), and no response (no change in size and number of warts).

  • cryotherapyProcedure or surgery

    patients received cryotherapy with liquid nitrogen once every 2 weeks until complete clearance or for a maximum of 3 sessions.Response to treatment will be evaluated 1 month after the last session by decrease in the size of warts, decrease in the number of warts and photographic comparison.

    The clinical response was graded into complete (complete cure), partial (if there was a decrease in the size and\or a decrease in the total number of warts), and no response (no change in size and number of warts).

Study groups in NCT03183765
Study groupRoleWhat they receive
MMR vaccineExperimentalMeasles-Mumps-Rubella Vaccine will be injected 0.5 ml into the largest wart at 2-week intervals until complete clearance was achieved or for a maximum of 3 treatments
Receives: Drug: Measles-Mumps-Rubella Vaccine
CryotherapyActive comparatorpatients received cryotherapy with liquid nitrogen once every 2 weeks until complete clearance or for a maximum of 3 sessions
Receives: Procedure: cryotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cure rate

    Assess cure rate of MMR vaccine and cryotherapy in treatment of common and planter warts (complete disappearance of lesions) one month after last session, compare efficacy of both measures.

    Measured: 60 days

Secondary outcomes (2)

  1. Detection of partial response to both measures

    if there was a decrease in the size or a decrease in the total number of warts

    Measured: 60 days

  2. Side effects

    Detection of post procedure side effects such as flu like symptoms, pain , hypopigmentation.

    Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2017
  2. Study start1 Aug 2017
  3. Primary completion1 Mar 2018
  4. Study completion1 May 2018

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03183765
Sponsor's protocol ID
MMRVCRYO
Status last verified
Jun 2020
First submitted
9 Jun 2017
Last updated
16 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shaheen 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 25847793

  • Tomson N, Sterling J, Ahmed I, Hague J, Berth-Jones J. Human papillomavirus typing of warts and response to cryotherapy. J Eur Acad Dermatol Venereol. 2011 Sep;25(9):1108-11. doi: 10.1111/j.1468-3083.2010.03906.x. Epub 2010 Nov 25.

    PubMed 21812829

  • Nofal A, Nofal E, Yosef A, Nofal H. Treatment of recalcitrant warts with intralesional measles, mumps, and rubella vaccine: a promising approach. Int J Dermatol. 2015 Jun;54(6):667-71. doi: 10.1111/ijd.12480. Epub 2014 Jul 29.

    PubMed 25070525

  • Johnson SM, Roberson PK, Horn TD. Intralesional injection of mumps or Candida skin test antigens: a novel immunotherapy for warts. Arch Dermatol. 2001 Apr;137(4):451-5.

    PubMed 11295925

  • Sapp M, Bienkowska-Haba M. Viral entry mechanisms: human papillomavirus and a long journey from extracellular matrix to the nucleus. FEBS J. 2009 Dec;276(24):7206-16. doi: 10.1111/j.1742-4658.2009.07400.x.

    PubMed 19878308

  • Castellsague X, Cohet C, Puig-Tintore LM, Acebes LO, Salinas J, San Martin M, Breitscheidel L, Remy V. Epidemiology and cost of treatment of genital warts in Spain. Eur J Public Health. 2009 Jan;19(1):106-10. doi: 10.1093/eurpub/ckn127. Epub 2008 Dec 26.

    PubMed 19112075

  • Choi MH, Seo SH, Kim IH, Son SW. Comparative study on the sustained efficacy of diphencyprone immunotherapy versus cryotherapy in viral warts. Pediatr Dermatol. 2008 May-Jun;25(3):398-9. doi: 10.1111/j.1525-1470.2008.00696.x.

    PubMed 18577059

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Measles-Mumps-Rubella Vaccine and cryotherapy in people with Common Wart and Plantar Wart, run by Assiut 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 16 Jun 2020. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cure rate (time frame: 60 days). 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 NCT03183765, which also lists 7 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 16 Jun 2020.

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