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

NCT03183765 | Completed Phase 4

• 1 other identifier: MMRVCRYO
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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 . Warts appear in various forms including verruca vulgaris, plane, plantar, filiform, digitate and periungual.

Conditions

Common Wart; Plantar Wart

Outcome Measures

Primary Outcomes (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.

  60 days

Secondary Outcomes (2)

• Detection of partial response to both measures

  60 days

• Side effects

  60 days

Study Arms (2)

MMR vaccine

EXPERIMENTAL

Measles-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

Drug: Measles-Mumps-Rubella Vaccine

Cryotherapy

ACTIVE COMPARATOR

patients received cryotherapy with liquid nitrogen once every 2 weeks until complete clearance or for a maximum of 3 sessions

Procedure: cryotherapy

Interventions

Measles-Mumps-Rubella Vaccine DRUG

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).

Also known as: MMR

MMR vaccine

cryotherapy PROCEDURE

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).

Cryotherapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospitals

Asyut, 71515, Egypt

Location

Related Publications (7)

• 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.

  PMID: 25847793 BACKGROUND

• 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.

  PMID: 21812829 BACKGROUND

• 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.

  PMID: 25070525 BACKGROUND

• 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.

  PMID: 11295925 BACKGROUND

• 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.

  PMID: 19878308 BACKGROUND

• 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.

  PMID: 19112075 BACKGROUND

• 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.

  PMID: 18577059 BACKGROUND

MeSH Terms

Conditions

Warts

Interventions

Measles-Mumps-Rubella Vaccine; Cryotherapy

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 12, 2017
• Study Start: August 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: May 1, 2018
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)