Immunotherapy in Eyelid Viral Papilloma | NCT06720467 | Trialant

Immunotherapy in Eyelid Viral Papilloma | NCT06720467 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with eyelid warts will receive treatment in the form of intralesional injection of Candida	Experimental	Intralesional injection of 0.2 ml of 1/1000 solution of Candida albicans antigen using an insulin syringe directly into the warts; Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.). The same injection was repeated every 2 weeks until complete clearance for a maximum of six treatment sessions.	Biological: Intralesional injection of Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intralesional injection of Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.)	Biological	Intralesional injection of 0.2 ml of 1/1000 solution of Candida albicans antigen using an insulin syringe directly into the warts; Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.). The same injection was repeated every 2 weeks until complete clearance for a maximum of six treatment sessions.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complete response	to report the complete response defined by the efficacy of intralesional injection of Candida antigen in achieving complete disappearance of eyelid warts and return to normal skin	after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions

Secondary Outcomes

Measure	Description	Time Frame
partial response	to report Partial response which will be considered when wart regress in size by 50%-99%.	after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
Failure

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Ayman Marie, Professor	Professor of Medical Microbiology and Immunology, Faculty of Medicine, Zagazig University, Egypt	Principal Investigator
Ghada Boghdadi, Professor	Professor of Medical Microbiology and Immunology, Faculty of Medicine, Zagazig University, Egypt	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31328869	Background	Marei A, Nofal A, Alakad R, Abdel-Hady A. Combined bivalent human papillomavirus vaccine and Candida antigen versus Candida antigen alone in the treatment of recalcitrant warts. J Cosmet Dermatol. 2020 Mar;19(3):758-762. doi: 10.1111/jocd.13077. Epub 2019 Jul 22.
26991521	Background	Aldahan AS, Mlacker S, Shah VV, Kamath P, Alsaidan M, Samarkandy S, Nouri K. Efficacy of intralesional immunotherapy for the treatment of warts: A review of the literature. Dermatol Ther. 2016 May;29(3):197-207. doi: 10.1111/dth.12352. Epub 2016 Mar 15.