Evaluate the Effectiveness and the Safety of a Medical Device in the Treatment of Common Warts and Plantar Warts.

NCT06214559 | Completed Results

• 1 other identifier: 23E2007
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

The principal aim of this study is to evaluate the efficacy and the safety of the tested product on common and plantar wart after 35 days of treatment. For this study, 33 patients presenting at least one common wart on the fingers, back on the hand or a plantar wart of a size between 0.1 and 0.5cm and present since less than 6 months will be included to reach this objective

Conditions

Warts; Plantar Wart; Common Wart

Outcome Measures

Primary Outcomes (1)

• Diameter of the Wart

  Clinical examination performed by the investigator to evaluate the diameter of the wart at D0 and 35 days after treatment. The effect of the product on clinical parameters will be evaluated by comparing the mean diameter before and after treatment.

  Day 0, Day 35

Secondary Outcomes (8)

• Global Improvement of the Wart

  Day 35

• Roughness of the Wart

  Day 0, Day 35

• Thickness of the Wart

  Day 0, Day 35

• Number of Dermal Papillae

  Day 0, Day 35

• Number of Participants Who Participated in Photography Session

  Day 0, Day 35

Study Arms (1)

Serum VERRUPRO

EXPERIMENTAL

To be applied twice a day

Device: Sérum VERRUPRO

Interventions

Sérum VERRUPRO DEVICE

To be applied twice a day

Serum VERRUPRO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient having given freely her/his informed, written consent. Patient having a good general health. Age: more than 18 years. Patient cooperative and aware of the device's modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
• Patient being psychologically able to understand information and to give his/her consent.
• Patient presenting at least 1 common wart, present since less than 6 months, on the fingers, back of the hands (60% of patients) and/or at least 1 plantar wart (40% of patients).
• Patient presenting wart of a size between 0,1 and 0,5 cm. Women of childbearing potential should use an accepted contraceptive regimen (at the Investigator's discretion) since at least 12 weeks before the beginning of the study and during all the study.

You may not qualify if:

• For plantar wart: wart on the point of support. Wart with keratosis. Wart in mosaic. Pregnant or nursing woman or planning a pregnancy during the investigation. Patient considered by the investigator likely to be non-compliant with the protocol.
• Patient enrolled in another clinical trial during the test period. Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.
• Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk.
• Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, immunocompromised patient HIV, psoriasis, lichen planus, immunosuppressive pathology, chronic venous insufficiency, Peripheral Arterial Obstructive Disease, delay or lack of ungual growth … Patient with cutaneous pathology on studied zone other than warts.

Sponsors & Collaborators

• Swiss Footcare Laboratories - Poderm Professional: lead

Study Sites (2)

L'Activité Privée Complémentaire (APC) Habib Thameur hospital

Tunis, 1082, Tunisia

Location

Private practice

Tunis, 2074, Tunisia

Location

MeSH Terms

Conditions

Warts

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

Results Point of Contact

• Title: Project Manager
• Organization: Eurofins Dermscan Pharmascan

manon.laune@cpt.eurofinseu.com

+33 (0)4 72 82 36 56

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 19, 2024
• Study Start: February 19, 2024
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)