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

NCT03158168 | Unknown Phase 3

• 1 other identifier: candida and zinc in warts
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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. \[ 1 \].

Conditions

Warts

Outcome Measures

Primary Outcomes (1)

• complete resolution of the injected wart

  by photography

  9 weeks

Study Arms (2)

study group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Interventions

Candida Antigen DRUG

Candida Albicans Antigen injection

study group

Zinc Sulfate DRUG

Zinc Sulfate injection

control group

Eligibility Criteria

• Age: 5 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

RECRUITING

Related Publications (15)

• Lynch MD, Cliffe J, Morris-Jones R. Management of cutaneous viral warts. BMJ. 2014 May 27;348:g3339. doi: 10.1136/bmj.g3339. No abstract available.

  PMID: 24865780 BACKGROUND

• Bacelieri R, Johnson SM. Cutaneous warts: an evidence-based approach to therapy. Am Fam Physician. 2005 Aug 15;72(4):647-52.

  PMID: 16127954 BACKGROUND

• Gibbs S, Harvey I. Topical treatments for cutaneous warts. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD001781. doi: 10.1002/14651858.CD001781.pub2.

  PMID: 16855978 BACKGROUND

• Scheinfeld N. Treatment of molluscum contagiosum: a brief review and discussion of a case successfully treated with adapelene. Dermatol Online J. 2007 Jul 13;13(3):15.

  PMID: 18328209 BACKGROUND

• Sinha S, Relhan V, Garg VK. Immunomodulators in warts: Unexplored or ineffective? Indian J Dermatol. 2015 Mar-Apr;60(2):118-29. doi: 10.4103/0019-5154.152502.

  PMID: 25814698 BACKGROUND

• Sterling JC, Gibbs S, Haque Hussain SS, Mohd Mustapa MF, Handfield-Jones SE. British Association of Dermatologists' guidelines for the management of cutaneous warts 2014. Br J Dermatol. 2014 Oct;171(4):696-712. doi: 10.1111/bjd.13310. Epub 2014 Oct 1. No abstract available.

  PMID: 25273231 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

• Silverberg NB, Lim JK, Paller AS, Mancini AJ. Squaric acid immunotherapy for warts in children. J Am Acad Dermatol. 2000 May;42(5 Pt 1):803-8. doi: 10.1067/mjd.2000.103631.

  PMID: 10775858 BACKGROUND

• Rogers CJ, Gibney MD, Siegfried EC, Harrison BR, Glaser DA. Cimetidine therapy for recalcitrant warts in adults: is it any better than placebo? J Am Acad Dermatol. 1999 Jul;41(1):123-7. doi: 10.1016/s0190-9622(99)70421-4.

  PMID: 10411426 BACKGROUND

• Orlow SJ, Paller A. Cimetidine therapy for multiple viral warts in children. J Am Acad Dermatol. 1993 May;28(5 Pt 1):794-6. doi: 10.1016/s0190-9622(09)80278-8. No abstract available.

  PMID: 8496433 BACKGROUND

• Nofal A, Nofal E. Intralesional immunotherapy of common warts: successful treatment with mumps, measles and rubella vaccine. J Eur Acad Dermatol Venereol. 2010 Oct;24(10):1166-70. doi: 10.1111/j.1468-3083.2010.03611.x.

  PMID: 20202055 BACKGROUND

• Perman M, Sterling JB, Gaspari A. The painful purple digit: an alarming complication of Candida albicans antigen treatment of recalcitrant warts. Dermatitis. 2005 Mar;16(1):38-40.

  PMID: 15996350 BACKGROUND

• Raza N, Khan DA. Zinc deficiency in patients with persistent viral warts. J Coll Physicians Surg Pak. 2010 Feb;20(2):83-6.

  PMID: 20378032 BACKGROUND

• Lopez-Garcia DR, Gomez-Flores M, Arce-Mendoza AY, de la Fuente-Garcia A, Ocampo-Candiani J. Oral zinc sulfate for unresponsive cutaneous viral warts: too good to be true? A double-blind, randomized, placebo-controlled trial. Clin Exp Dermatol. 2009 Dec;34(8):e984-5. doi: 10.1111/j.1365-2230.2009.03623.x. No abstract available.

  PMID: 20055878 BACKGROUND

• Youssef EMK, Eissa MAA, Bakr RM. Intralesional Candida albicans antigen versus intralesional zinc sulfate in treatment of cutaneous warts. Arch Dermatol Res. 2023 Jul;315(5):1305-1314. doi: 10.1007/s00403-022-02499-w. Epub 2022 Dec 26.

  PMID: 36567351 DERIVED

MeSH Terms

Conditions

Warts

Interventions

PRA1 protein, Candida albicans; Zinc Sulfate

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)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Central Study Contacts

Eman Mohamed Kamal, MD

CONTACT

01005369338; emohanya@yahoo.com

Radwa Bakr, MD

CONTACT

01119988 115; radwabakr2011@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: March 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 24, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)