Efficacy of Intralesional MMR Vaccine,Intralesional Candidal Antigen&Topical Podophyllin in Treatment of Genital Warts

NCT ID: NCT03853785

Last Updated: 2019-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-29
• Study Completion Date: 2021-12-31

Brief Summary

This study compares the safety and efficacy of intralesional Candidal antigen versus Intralesional MMR vaccine versus podophyllin for treatment of genital warts.

Detailed Description

Anogenital human papillomavirus (HPV) is a highly prevalent sexually transmitted infection ,seen predominantly in young adults.

Condyloma acuminata or benign anogenital warts are typically caused by HPV-6 OR 11 which are considered low risk types.Persistent infection with high risk HPV types predominantly HPV-16 and 18 is the primary and major cause of cervical cancers and a subset of vaginal,vulvar, penile , anal ,oropharyngeal and rarely squamous cell carcinoma of the digits.

Warts may reflect a localized or systemic cell-mediated immune (CMI) deficiency to HPV.

Anogenital warts may appear as a single lesion or in clusters as flat, flesh-coloured to pigmented plaques or rough-surfaced papules and exophytic nodules.

The conventional modalities in treatment of warts include destructive therapies such as salicylic acid, trichloroacetic acid, cryotherapy, silver nitrate, phenol, cantharidin, surgical interventions and lasers; antiproliferative agents such as bleomycin, podophyllin, podophyllotoxin, and 5-fluro uracil; antiviral agents such as cidofovir and retinoids.

Because of the cumbersome nature of these procedures and a high risk of recurrence, immunotherapy is becoming more and more popular, especially in the treatment of refractory cutaneous and genital warts.It enhances recognition of the virus by the immune system. immunotherapy not only causes a resolution of the treated wart but also leads to clearance of distant warts, at least in a subset of the responders.

Immunotherapy in warts can be administered by various methods. The first method is topical application of certain inorganic molecules that are capable of eliciting a contact hypersensitivity reaction with secondary activation of an immunological response .or even topical applications of immune modulators like imiquimod,A second modality is the use of oral immune modulators such as cimetidine,and levamisole .

A third method is Intralesional injection of immunotherapeutic agent that utilizes the ability of the immune system to mount a delayed type hypersensitivity response to various antigens and also the wart tissue leading to production of Th1 cytokines which activate cytotoxic and natural killer cells to eradicate HPV infection.

Immunotherapy with different skin test antigens like Candida, mumps or trichophyton antigen is a relatively new treatment option for warts. Candida antigen reported success in majority of patients treated with this test antigen .

Mumps, measles and rubella (MMR) vaccine is a freeze-dried preparation of live attenuated strains of measles, mumps and rubella viruses (0.5 ml/dose). In some of the previous studies, it has been shown that mumps-measles-rubella (MMR) vaccine results in regression of warts via immunomodulation and induction of immune system.

Conditions

Condylomata Acuminata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intralesional MMR vaccine

Intralesional Mumps, measles and rubella (MMR) vaccine in genital warts

Group Type: ACTIVE_COMPARATOR

MMR vaccine

Intervention Type: BIOLOGICAL

Intralesional injection of 0.5 ml MMR vaccine in the largest lesion . Injections will be repeated into the same lesion every 2 weeks for a maximum of three treatment sessions.

intralesional candida antigen

intralesional candida antigen in genital warts

Group Type: ACTIVE_COMPARATOR

Candida antigen

Intervention Type: BIOLOGICAL

Intralesional injection of Candidal antigen with a dose of (0.1ml -0.3ml) by an insulin syringe in the largest wart at the first visit. Injections will be repeated for all patients into the same lesion every 2 weeks for a maximum of three treatment sessions.

Topical Podophyllin

Topical Podophyllin in genital warts

Group Type: ACTIVE_COMPARATOR

Topical Podophyllin

Intervention Type: DRUG

It will be applied to the wart by using a cotton tipped swab once a week . The procedure will be limited to 10 cm2 per session .Surrounding skin will be protected by Vaseline. Podophyllin will be washed 4 hour after application . The procedure will be repeated every week till 6 weeks .

Interventions

MMR vaccine

Intralesional injection of 0.5 ml MMR vaccine in the largest lesion . Injections will be repeated into the same lesion every 2 weeks for a maximum of three treatment sessions.

Intervention Type: BIOLOGICAL

Candida antigen

Intralesional injection of Candidal antigen with a dose of (0.1ml -0.3ml) by an insulin syringe in the largest wart at the first visit. Injections will be repeated for all patients into the same lesion every 2 weeks for a maximum of three treatment sessions.

Intervention Type: BIOLOGICAL

Topical Podophyllin

It will be applied to the wart by using a cotton tipped swab once a week . The procedure will be limited to 10 cm2 per session .Surrounding skin will be protected by Vaseline. Podophyllin will be washed 4 hour after application . The procedure will be repeated every week till 6 weeks .

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with anogenital warts with ages ranging from 3 to 50 years
• Genital warts resistant to treatment
• Genital warts that had relapsed at least once after treatment with any of the tissue-destructive modalities.

Exclusion Criteria

• Patients with any evidence of immunosuppression
• Eczematous skin disorder
• Those with any history of hypersensitivity to Candida albicans antigen
• Pregnant or lactating women.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Meriam Mamdouh Boshra

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hisham Zayan, MD

Role: CONTACT

hishamzayan@yahoo.com

201223971409 ext. 00+20

Yasmin tawfik, MD

Role: CONTACT

dr.yasminmostawfik@yahoo.com

201006033331 ext. 00+20

Other Identifiers

MMR vaccine in genital warts

Identifier Type: -

Identifier Source: org_study_id