Testing VERRUTOP® liquid to treat warts on the hands in children and teenagers
| ISRCTN | ISRCTN90862249 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90862249 |
| Secondary identifying numbers | ISDINTOP W1 |
- Submission date
- 04/09/2019
- Registration date
- 06/09/2019
- Last edited
- 07/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
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
Contact information
Public
ISDIN S.A.
Provençals 33
Barcelona
08019
Spain
| Phone | +34 (0)932402020 |
|---|---|
| javier.bustos@isdin.com |
Study information
| Study design | Prospective and open study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Evaluation of the application of VERRUTOP® in the treatment of palmoplantar and periungual warts in the paediatric population |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 study start date | 21/12/2017 |
| Completion date | 18/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 12 |
| Total final enrolment | 12 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2018 |
| Date of final enrolment | 18/08/2018 |
Locations
Countries of recruitment
- Spain
Study participating centre
Palma de Mallorca (Islas Baleares)
07020
Spain
Sponsor information
Industry
Provençals 33
Barcelona
08019
Spain
| Phone | +34 (0)932402020 |
|---|---|
| javier.bustos@isdin.com | |
"ROR" |
https://ror.org/04dg86p75 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/10/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers intend to publish the study results in an international peer-reviewed indexed scientific journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2019 | 07/10/2019 | Yes | No |
Editorial Notes
07/10/2019: Publication reference and total final enrolment number added.
06/09/2019: Trial's existence confirmed by ethics committee.
