Gardasil Versus Cervarix in the Treatment of Warts

NCT05383625 | Completed Phase 3 FDA Drug

• 1 other identifier: ZU-IRB#5859/15-1-2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Warts are common, benign, epidermal proliferations caused by HPV infecting skin and mucous membranes. Treatment of warts poses a true challenge despite existing variable therapeutic modalities, whether destructive or immunotherapeutic. Human papilloma virus (HPV) vaccines are FDA approved for the prevention of genital warts and wart related precancerous and cancerous lesions but they are not indicated for treatment of preexisting warts yet

Conditions

Verruca Viral

Outcome Measures

Primary Outcomes (1)

• Therapeutic response

  The percentage of patients in each group achieving complete, partial or no response at the end of the treatment sessions

  Through study completion for a maximum of 12 weeks, evaluation held at two weeks interval and at the end of treatment sessions (12th week visit)

Secondary Outcomes (3)

• Safety measure

  Through study completion every treatment session held at two weeks interval for a maximum of 5 sessions

• Safety measure

  Through study completion for a maximum of 12 weeks held every two weeks till the end of the treatment sessions (12th week visit)

• Recurrence

  6 months following the end of treatment sessions

Study Arms (3)

Quadrivalent vaccine

EXPERIMENTAL

Patient receive 0.1 ml of quadrivalent HPV vaccine intralesional every two weeks

Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine

Bivalent Vaccine

EXPERIMENTAL

Patient received 0.1 ml of bivalent HPV vaccine intralesional once every two weeks

Drug: Bivalent Human Papilloma Virus Vaccine

Saline control

PLACEBO COMPARATOR

Patient received 0.1 ml of intralesional saline once every two weeks

Drug: Saline

Interventions

Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine DRUG

intralesional 0.1 ml every two weeks

Quadrivalent vaccine

Bivalent Human Papilloma Virus Vaccine DRUG

Intralesional 0.1 ml every two weeks

Bivalent Vaccine

Saline DRUG

intralesional into the largest warts every two weeks

Saline control

Eligibility Criteria

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

You may qualify if:

• Adult Patients with recalcitrant multiple warts of any type. Warts were considered recalcitrant if they persisted for at least 6 months without any response to 2 different therapeutic modalities or more.
• Immunocompetent patients.
• Patients who do not receive any treatment of warts for at least 1 month before the start of study.
• Patients who are able to understand and follow the study protocol and approve to sign the informed consent

You may not qualify if:

• Patients with acute febrile illness.
• Past history of asthma.
• Allergic skin disorders, such as generalized eczema, or severe urticaria.
• Pregnancy or lactation
• History of hypersensitivity to the treatment vaccines.
• Children
• Immunocompromised patients
• Patients unable to follow the study protocol

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University

Zagazig, Select Region, 44511, Egypt

Location

Related Publications (5)

• Nofal A, Marei A, Amer A, Amen H. Significance of interferon gamma in the prediction of successful therapy of common warts by intralesional injection of Candida antigen. Int J Dermatol. 2017 Oct;56(10):1003-1009. doi: 10.1111/ijd.13709. Epub 2017 Aug 8.

  PMID: 28791682 BACKGROUND

• Nofal A, Marei A, Ibrahim AM, Nofal E, Nabil M. Intralesional versus intramuscular bivalent human papillomavirus vaccine in the treatment of recalcitrant common warts. J Am Acad Dermatol. 2020 Jan;82(1):94-100. doi: 10.1016/j.jaad.2019.07.070. Epub 2019 Jul 29.

  PMID: 31369771 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

• Landis MN, Lookingbill DP, Sluzevich JC. Recalcitrant plantar warts treated with recombinant quadrivalent human papillomavirus vaccine. J Am Acad Dermatol. 2012 Aug;67(2):e73-4. doi: 10.1016/j.jaad.2011.08.022. No abstract available.

  PMID: 22794819 BACKGROUND

• Kreuter A, Waterboer T, Wieland U. Regression of cutaneous warts in a patient with WILD syndrome following recombinant quadrivalent human papillomavirus vaccination. Arch Dermatol. 2010 Oct;146(10):1196-7. doi: 10.1001/archdermatol.2010.290. No abstract available.

  PMID: 20956677 BACKGROUND

MeSH Terms

Interventions

Vaccines, Synthetic; Sodium Chloride

Intervention Hierarchy (Ancestors)

Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; Antigens; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 20, 2022
• Study Start: September 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)