Evaluation of the Efficacy of Cryotherapy Combined With Intralesional Hepatitis B Virus Vaccine Versus Either Therapy in the Treatment of Multiple Cutaneous Warts :a Comparative Study

NCT05902624 | Not Yet Recruiting Early Phase 1

• 1 other identifier: cutaneous warts treatment
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.investigate the efficacy and safety of combined cryotherapy with intralesional HBV vaccine injection in the treatment of multiple common warts.
2. 2.compare the efficacy and safety of the combined treatment versus either therapy in the treatment of multiple cutaneous warts.

Conditions

Cutaneous Warts

Outcome Measures

Primary Outcomes (2)

• Investigate the efficacy and safety of combined cryotherapy with intralesional HBV vaccine injection in the treatment of multiple common warts.

  size of cutaneous warts in millimeters will be measured every visit

  10 weeks

• Compare the efficacy and safety of the combined treatment versus either therapy in the treatment of multiple cutaneous warts.

  number of cutaneous warts will be measured every visit

  10 weeks

Study Arms (3)

Group intralesional injection of HBV vaccine

OTHER

Group 1: will include 20 patients with multiple cutaneous warts. They will be treated by intralesional injection of HBV vaccine into the largest wart by an insulin syringe every 2-weeks until complete clearance or for a maximum of 5 sessions.

Drug: Hepatitis B Virus Vaccine(HBV)

Group cryotherapy

OTHER

Group 2: will include 20 patients with multiple cutaneous warts. They will be treated by cryotherapy every 2-weeks until complete clearance or for a maximum of 5 sessions.

Drug: Hepatitis B Virus Vaccine(HBV)

Group cryotherapy with intralesional injection of HBV vaccine

OTHER

Group 3: will include 20 patients with multiple cutaneous warts. They will be treated by cryotherapy with intralesional injection of HBV vaccine into the largest wart by an insulin syringe every 2-weeks until complete clearance or for a maximum of 5 sessions.

Drug: Hepatitis B Virus Vaccine(HBV)

Interventions

Hepatitis B Virus Vaccine(HBV) DRUG

Hepatitis B Virus Vaccine(HBV)

Also known as: cryotherapy

Group cryotherapy; Group cryotherapy with intralesional injection of HBV vaccine; Group intralesional injection of HBV vaccine

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patients with multiple cutaneous warts of any site.
• Patients age above 10 years old
• No concurrent systemic or topical treatment of warts

You may not qualify if:

• Pregnancy and lactation.
• 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.
• Patients with history of neuropathy or peripheral ischemia.
• Patients with signs of inflammation or infection.
• Patients with history of a serious systemic or anaphylactic reaction or allergy to a prior dose of HBV vaccine or to any of its components.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• Nofal A, Salah E, Nofal E, Yosef A. Intralesional antigen immunotherapy for the treatment of warts: current concepts and future prospects. Am J Clin Dermatol. 2013 Aug;14(4):253-60. doi: 10.1007/s40257-013-0018-8.

  PMID: 23813361 BACKGROUND

• Thappa DM, Chiramel MJ. Evolving role of immunotherapy in the treatment of refractory warts. Indian Dermatol Online J. 2016 Sep-Oct;7(5):364-370. doi: 10.4103/2229-5178.190487.

  PMID: 27730031 BACKGROUND

• Araujo MG, Magalhaes GM, Garcia LC, Vieira EC, Carvalho-Leite MLR, Guedes ACM. Update on human papillomavirus - Part II: complementary diagnosis, treatment and prophylaxis. An Bras Dermatol. 2021 Mar-Apr;96(2):125-138. doi: 10.1016/j.abd.2020.11.005. Epub 2021 Feb 16.

  PMID: 33637397 BACKGROUND

• Burlamaqui JC, Cassanti AC, Borim GB, Damrose E, Villa LL, Silva L. Human Papillomavirus and students in Brazil: an assessment of knowledge of a common infection - preliminary report. Braz J Otorhinolaryngol. 2017 Mar-Apr;83(2):120-125. doi: 10.1016/j.bjorl.2016.02.006. Epub 2016 Apr 22.

  PMID: 27170346 BACKGROUND

• Mohammed GF, Al-Dhubaibi MS, Bahaj SS, Elneam AIA. Systemic immunotherapy for the treatment of warts: A literature review. J Cosmet Dermatol. 2022 Nov;21(11):5532-5536. doi: 10.1111/jocd.15330. Epub 2022 Aug 31.

  PMID: 36017650 BACKGROUND

• Nofal A, Elaraby A, Elkholy BM. Intralesional Versus Intramuscular Hepatitis B Virus Vaccine in the Treatment of Multiple Common Warts. Dermatol Surg. 2022 Nov 1;48(11):1178-1184. doi: 10.1097/DSS.0000000000003595. Epub 2022 Sep 23.

  PMID: 36165681 BACKGROUND

• Nofal A, Elsayed E, Abdelshafy AS. Hepatitis B virus vaccine: A potential therapeutic alternative for the treatment of warts. J Am Acad Dermatol. 2021 Jan;84(1):212-213. doi: 10.1016/j.jaad.2020.04.128. Epub 2020 Apr 29. No abstract available.

  PMID: 32360758 BACKGROUND

• Perez-Gonzalez A, Cachay E, Ocampo A, Poveda E. Update on the Epidemiological Features and Clinical Implications of Human Papillomavirus Infection (HPV) and Human Immunodeficiency Virus (HIV) Coinfection. Microorganisms. 2022 May 18;10(5):1047. doi: 10.3390/microorganisms10051047.

  PMID: 35630489 BACKGROUND

• Colpani V, Soares Falcetta F, Bacelo Bidinotto A, Kops NL, Falavigna M, Serpa Hammes L, Schwartz Benzaken A, Kalume Maranhao AG, Domingues CMAS, Wendland EM. Prevalence of human papillomavirus (HPV) in Brazil: A systematic review and meta-analysis. PLoS One. 2020 Feb 21;15(2):e0229154. doi: 10.1371/journal.pone.0229154. eCollection 2020.

  PMID: 32084177 BACKGROUND

• Abou-Taleb DAE, Abou-Taleb HA, El-Badawy O, Ahmed AO, Thabiet Hassan AE, Awad SM. Intralesional vitamin D3 versus intralesional purified protein derivative in treatment of multiple warts: A comparative clinical and immunological study. Dermatol Ther. 2019 Sep;32(5):e13034. doi: 10.1111/dth.13034. Epub 2019 Aug 7.

  PMID: 31355514 BACKGROUND

• Magalhaes GM, Vieira EC, Garcia LC, De Carvalho-Leite MLR, Guedes ACM, Araujo MG. Update on human papilloma virus - part I: epidemiology, pathogenesis, and clinical spectrum. An Bras Dermatol. 2021 Jan-Feb;96(1):1-16. doi: 10.1016/j.abd.2020.11.003. Epub 2020 Dec 10.

  PMID: 33341319 BACKGROUND

• Ju HJ, Park HR, Kim JY, Kim GM, Bae JM, Lee JH. Intralesional immunotherapy for non-genital warts: A systematic review and meta-analysis. Indian J Dermatol Venereol Leprol. 2022 Nov-Dec;88(6):724-737. doi: 10.25259/IJDVL_1369_20.

  PMID: 35962514 BACKGROUND

• Cubie HA. Diseases associated with human papillomavirus infection. Virology. 2013 Oct;445(1-2):21-34. doi: 10.1016/j.virol.2013.06.007. Epub 2013 Aug 9.

  PMID: 23932731 BACKGROUND

MeSH Terms

Interventions

Hepatitis B Vaccines; Cryotherapy

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Therapeutics

Study Officials

• Maria Awny, Master

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Awny, Master

CONTACT

01274724482; maria.awny11@gmail.com

Sahar Abd-Elmoez, Professor

CONTACT

01008899446; saharsotohy@yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: June 15, 2023
• Study Start: August 1, 2024
• Primary Completion: May 20, 2025
• Study Completion: August 20, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07