Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age9+
SponsorZagazig University

About this trial

To follow up the efficacy and safety of Candida antigen, bivalent HPV vaccine in treatment of common warts either mono or combined intralesional therapy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients with multiple, recalcitrant, or non-recalcitrant common warts of different sites, sizes, duration, and with or without distant lesions will be enrolled in the study

Disqualifiers

Pregnant female. Hypersensitivity to Candida antigen or bivalent HPV vaccine

Trial design

Design model

Factorial

Treatments tested in this trial

  • Candida antigen vaccine

    Biological/Vaccine

    we will study the efficacy and safety of agent in the treatment of multiple warts, we will follow up the recurrence rate of each group

  • Bivalent HPV vaccine

    Biological/Vaccine

    we will study the efficacy and safety of agent in the treatment of multiple warts, we will follow up the recurrence rate of each group

Treatment groups

162 Participants
are divided into 3 treatment groups
Group A: Candida antigen groupExperimental treatment 1 intervention
Group B: Bivalent HPV vaccineExperimental treatment 1 intervention
Group C: both agents groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

complete response

if there is disappearance of warts and return of the normal skin markings

Time frame
upto 3 months
2

partial response

if warts regressed in size by 50-99% (the size will be measured as the summation of size of all lesions in cm)

Time frame
upto 3 months
3

no response

if there is \< 50% decrease in wart size. (the size will be measured as the summation of size of all lesions in cm)

Time frame
upto 3 months

Secondary outcomes

1

recurrence rate after recovery

appearance of new lesions or recurrence of previous one

Time frame
follow up for 6 months after recovery

Other outcomes

Sponsors and contacts

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