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Intralesional Candidal Antigen Versus Intralesional Zinc Sulphate in Treatment of Cutaneous Warts

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ClinicalTrials.gov Identifier: NCT03158168
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
MAAbdelsalam, Assiut University

Brief Summary:
Warts are common and infectious viral diseases of the skin and are prevalent worldwide. Warts are caused by the human papilloma virus (HPV), which has more than 100 strains; some of them are known to be premalignant .Although warts can appear at any age, they are more common in children and adolescents. The prognosis of warts cannot be predicted. In some patients they may spontaneously disappear, whereas others show persistence and progression with spreading to other body sites, leading to physical and emotional distress to the patients. [ 1 ].

Condition or disease Intervention/treatment Phase
Warts Drug: Candida Antigen Drug: Zinc Sulfate Phase 3

Detailed Description:

Forty percent of children spontaneously clear in two years without treatment owing to natural immunity [ 2,3.]. However, warts can persist and increase in size and number [2] .

Warts may reflect a localized or systemic cell-mediated immune (CMI) deficiency to HPV. Various reasons like lack of production of memory T cells to target HPV infection, failure of clonal expansion of lymphocytes to adequate stimulation, inability of T lymphocytes to traffic to sites of infection and weak effector response mechanism have been hypothesized. [4] .] Consequently, warts are particularly exuberant in patients with Hodgkin's disease, AIDS and those on immunosuppressant [ 5 ].

The conventional modalities in treatment of warts include destructive therapies such as salicylic acid, trichloroacetic acid, cryotherapy, silver nitrate, phenol, canthiridin, electrocautary, surgical interventions and lasers; antiproliferative agents such as bleomycin, vitamin D analogs, podophyllin, 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 [ 6 ] . It enhances recognition of the virus by the immune system. This allows not only clearing of the treated wart, and frequently warts at distant anatomic sites, but also may prevent future clinical infection [ 7 ] .

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 [ 8 ] . A second modality is the use of oral immune modulators such as cimetidine and zinc(10mg/kg/day for 2months) [ 9 , 10 ] .

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. This clears not only the local warts but also distant warts unlike traditional wart therapies [ 11 ] .

There are a few side effects reported by most of the studies. The most common side effect was pain and discomfort during injection, however, serious side effects such as vitiligo-like depigmentation and painful purple digit have also been reported [ 12 ] .

Zinc is important for immune regulation as it stimulates the leucocytes and natural killer cells. It has been shown that there is a deficiency of zinc in patients with multiple or recurrent warts [ 13 ,14 ].The use of zinc in treatment of warts was proven in many studies either in the topical form or systemic oral therapy [ 15 ].. However, Little studies have utilized intralesional injection of 2% zinc sulfate solution for the treatment of common wart one of them was of [16] .


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intralesional Candidal Antigen Versus Intralesional Zinc Sulphate in Treatment of Cutaneous Warts, A Randomized Clinical Trial
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arm Intervention/treatment
Experimental: study group

The first group will receive Intralesional injection of Candidal antigen with a dose of (0.1ml -0.3ml) by insulin syringe in the largest wart at the first visit.( Only those patients who showed a positive response to the Candida test antigen).I njections will be repeated for all patients into the same lesion every 3 weeks for three treatment sessions. Follow up for next six months for any recurrences.

Storage: A 1ml multidose vial of candidal antigen (Candin) which is an intradermal test antigen, stored between 2c-8c.

Drug: Candida Antigen
Candida Albicans Antigen injection

Active Comparator: control group

The second group will receive an IL injection of 2%Zn sulfate with a dose of (0.1ml-0.3ml) by insulin syringe ,in the largest one .the wart is injected with the solution till blanching or bleb formation. Subcutaneous injections and acral parts such as fingers and toes will be avoided, as it may cause vascular necrosis [19]. Injections will be repeated for all patients into the same lesion every 2 weeks for three treatment sessions.Follow up for next six months for any recurrences.

Preparation of 2% zinc sulfate: A measure of 2g. of zinc sulfate powder is to be dissolved in 100 ml of sterile distilled water and autoclaved at 95c for 20 min(20).

Drug: Zinc Sulfate
Zinc Sulfate injection




Primary Outcome Measures :
  1. complete resolution of the injected wart [ Time Frame: 9 weeks ]
    by photography



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- patients with ages ranging from 10 to 40 years with cutaneous common or planter wart ,

  • or were either resistant to treatment
  • or had relapsed at least once after treatment with any of the tissue-destructive modalities

Exclusion Criteria:.- Patients with any evidence of immunosuppressant,

  • eczematous skin disorder,
  • those with any history of hypersensitivity to Candida albicans antigen,
  • pregnant or lactating women,
  • and those who received any wart treatment 1 month before the start of the study will be excluded from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158168


Contacts
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Contact: Eman Mohamed Kamal, MD 01005369338 emohanya@yahoo.com
Contact: Radwa Bakr, MD 01119988 115 radwabakr2011@hotmail.com

Locations
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Egypt
Assiut University Hospital Recruiting
Assiut, Egypt
Contact: Radwa Bakr, MD    01119988115    radwabakr2011@hotmail.com   
Contact: Eman Kamal, MD    01005369338    emohanya@yahoo.com   
Sponsors and Collaborators
Assiut University

Publications:

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Responsible Party: MAAbdelsalam, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03158168     History of Changes
Other Study ID Numbers: candida and zinc in warts
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Astringents
Dermatologic Agents