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

Warts Clinical Trial

Official title:

Prospective Multicentric, Before After Study to Evaluate the Effectiveness and the Safety of a Medical Device in the Treatment of Common Warts and Plantar Warts.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06214559
• Other study ID #: 23E2007
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: April 2024

Study information

• Verified date: March 2024
• Source: Swiss Footcare Laboratories - Poderm Professional
• Contact: Charlotte Bosson
• Phone: +41 78 245 18 78
• Email: c.bosson[@]poderm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Warts are the cutaneous manifestations of human papillomavirus (HPV). (1) Cutaneous warts are benign, spontaneously regressing, epithelial tumors differing in clinical morphology depending on the human papilloma virus HPV-types. (2) Warts may exist in different forms given the epithelial surface and HPV type responsible for the infection. Common warts (Verruca vulgaris), plantar warts (Verruca plantaris), flat or planar warts (Verruca plana), and genital warts (Condyloma acuminata) are some of the clinical manifestations of HPV infection. (1) Warts are most common on your hands, feet, and face. (3)

Warts are common worldwide and affect approximately 10% of the population. In school-aged children, the prevalence is as high as 10% to 20% (4). The range of greatest incidence is between 12 and 16 years of age. (1) It is known that nearly two-thirds of warts spontaneously disappear within 24 months. (4)

The majority of warts do not cause symptoms. However, they do cause cosmetic disfigurement and, in a rare patient, may cause localized pain. Plantar warts can be painful because of compression and extensive friction that can lead to bleeding. (4) Once the diagnosis is made, the treatment depends on symptoms, patient preferences, and cost. Even though there are many treatments for warts, none is very effective, and recurrences are common with each of them. (4) This is why, developing a product that is effective against warts seems necessary.

PODERM Professional has developed an innovative wart-treatment formula based on biomimetics. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Common Wart
• Foot Diseases
• Plantar Wart
• Warts

Intervention

Device:
• Sérum VERRUPRO
To be applied twice a day

Locations

Country	Name	City	State
Tunisia	L'Activité Privée Complémentaire (APC) Habib Thameur hospital	Tunis
Tunisia	Private practice	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Footcare Laboratories - Poderm Professional

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	global improvement of the wart	The global improvement of the wart will be assessed by the investigator after 35 days of treatment.	Day 35
Secondary	Roughness of the wart	The effect of the product on these clinical parameters will be evaluated by a comparison before and after treatment.	Day 0, Day 35
Secondary	Thickness of the wart	The effect of the product on these clinical parameters will be evaluated by a comparison before and after treatment.	Day 0, Day 35
Secondary	Number of dermal papillae	The effect of the product on these clinical parameters will be evaluated by a comparison before and after treatment.	Day 0, Day 35
Secondary	Photography	Illustration of the effectiveness of Sérum VERRUPRO® on the skin aspect before and after the treatment with photographs.	Day 0, Day 35
Secondary	Patient evaluation	Analysis of the answers to the patient questionnaire regarding effectiveness, tolerance, and acceptability of the investigational device 35 days after treatment.	Day 35
Secondary	Adverse event	Products safety will be assessed by collection of Adverse Events (AEs) throughout the study. AEs will be summarized and tabulated by severity, causality, action taken and outcome, using descriptive statistics.	Day 0, Day 35
Secondary	Product tolerance	Product tolerance will be assessed by the investigator at D0 (before the product use) and D35 by a clinical examination.	Day 0, Day 35