Condition category
Skin and Connective Tissue Diseases
Date applied
04/09/2019
Date assigned
06/09/2019
Last edited
07/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
Warts are very common and can affect anybody. They are caused by several viruses. Palmoplantar warts (warts on the palm of the hand), especially in babies and toddlers, are a common reason for a visit to a dermatology (skin) clinic. There can be several warts in a small area, meaning that it can be too painful for the child to have them all treated at the same time by the doctor freezing them with liquid nitrogen. Nitric-zinc complex solution (NZCS) is a liquid containing nitric acid, zinc, copper and organic acids, sold as Verrutop®, that can be applied to the wart (including warts on the palm or close to the fingernail) to reduce its size painlessly. This study aims to investigate whether Verrutop® treatment is effective and tolerable in children and teenagers with warts on the palm or near the fingernail.

Who can participate?
Children over 5 years old with warts on the palm or near the fingernail.

What does the study involve?
Verrutop® is applied directly to warts using thin tube until the wart changes colour. This application is repeated, with intervals of at least 2 weeks, until the wart has disappeared or until the investigator considers that no further treatment is required.

What are the possible benefits and risks of participating?
The frequent follow-ups can benefit the participants because they are more likely to have the wart treated regularly. The Verrutop® application is only applied to the wart and not the skin around it, so the normal skin should not be damaged. Verrutop® stimulates the release of a substance called nitric oxide, which can protect against viral infection, so it is less likely that the wart will regrow. Side effects are extremely rare and occur only where the liquid has been applied.

Where is the study run from?
Hospital Universitario Son Espases (Spain)

When is the study starting and how long is it expected to run for?
January 2018 to December 2018.

Who is funding the study?
ISDIN SA (Spain)

Who is the main contact?
Javier Bustos, javier.bustos@isdin.com

Trial website

Contact information

Type

Public

Primary contact

Miss Javier Bustos

ORCID ID

Contact details

ISDIN S.A.
Provençals 33
Barcelona
08019
Spain
+34 (0)932402020
javier.bustos@isdin.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

ISDINTOP W1

Study information

Scientific title

Evaluation of the application of VERRUTOP® in the treatment of palmoplantar and periungual warts in the paediatric population

Acronym

Study hypothesis

Verrutop® is already in use in adults and children. It induces a painless caustic effect on 'difficult-to-treat' warts, including those in palmoplantar and periungual locations. However, there are few data available on this product in children and adolescents in clinical studies; therefore, the objective of the present study was to describe the efficacy and tolerability of Verrutop® in the treatment of palmoplantar and periungual warts in this population.

Ethics approval

Approved 27/02/2018, Comité d'Ética de la Investigació de les llles Balears (CEl-lB) (Son Espases Hospital Univeristari) , C/Crta. de Valldermossa, 79 07120 Palma Mallorca; Tel: +34 (0)871 205 000; Email: sonespases.info@ssib.es), ref: CI-214-18

Study design

Prospective and open study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Palmoplantar and periungual warts

Intervention

Verrutop® is topically applied on warts using a 30 µL capillary tube on each lesion until the wart changes color. Patients received Verrutop application every 2 weeks, until the wart was resolved or until the investigator considered that no further treatment was required. Product quantity applied is under investigator’s criteria.

Intervention type

Device

Phase

Phase IV

Drug names

Verrutop

Primary outcome measure

Clearance of warts assessed by a dermatologist at the clinical site during all study visits and at the end of treatment. Complete clearance of verruca will be defined as the restoration of normal skin upon close inspection.

Secondary outcome measures

1. Number of sessions needed for complete disappearance of warts
2. Physician’s global satisfaction evaluation
3. Physician and patient's evaluation of esthetic results
4. Tolerability of treatment

Overall trial start date

21/12/2017

Overall trial end date

18/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Eligible patients were immunocompetent children and adolescents, with at least one palmoplantar or periungual wart suitable for topical treatment
2. Patients who had not used any other topical treatment during the previous month

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

12

Total final enrolment

12

Participant exclusion criteria

1. Pregnancy or lactation
2. Received previous treatments interfering with the evaluation of the warts during 30 days previous to be included in the study

Recruitment start date

01/03/2018

Recruitment end date

18/08/2018

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Universitario Son Espases
Carretera de Valldemossa, 79,
Palma de Mallorca (Islas Baleares)
07020
Spain

Sponsor information

Organisation

ISDIN S.A.

Sponsor details

Provençals 33
Barcelona
08019
Spain
+34 (0)932402020
javier.bustos@isdin.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

ISDIN S.A

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers intend to publish the study results in an international peer-reviewed indexed scientific journal.

IPD sharing statement:
The datasets generated and analysed during the current study will be available upon request and for no less than 5 years from Javier Bustos (javier.bustos@isdin.com). The data sets are stored on MS Excel spreadsheets and all appropriate requests for appropriate analysis and mechanisms will be considered.
Written informed consent from participants was obtained.

Intention to publish date

01/10/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31586309 (added 07/10/2019)

Publication citations

Additional files

Editorial Notes

07/10/2019: Publication reference and total final enrolment number added. 06/09/2019: Trial's existence confirmed by ethics committee.