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

Swiss Footcare Laboratories - Poderm Professional33 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

Conditions

Warts Plantar Wart Common Wart

Interventions

Sérum VERRUPRODEVICE

To be applied twice a day

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

L'Activité Privée Complémentaire (APC) Habib Thameur hospital

Tunis, Tunisia

Private practice

Tunis, Tunisia

Outcomes

Primary Outcomes

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.

Time frame: Day 0, Day 35

Secondary Outcomes

Global Improvement of the Wart

The global improvement of the wart will be assessed by the investigator after 35 days of treatment.

Time frame: Day 35

Roughness of the Wart

The effect of the product on these clinical parameters will be evaluated by a comparison before and after treatment. This outcome was measured using a scale from 0 (No roughness) to 5 (very severe roughness).

Time frame: Day 0, Day 35

Thickness of the Wart

The effect of the product on these clinical parameters will be evaluated by a comparison before and after treatment. This outcome was measured using a scale form 0 (no tickness) to 4(Very severe)

Time frame: Day 0, Day 35

Number of Dermal Papillae

The effect of the product on these clinical parameters will be evaluated by a comparison before and after treatment.

Time frame: Day 0, Day 35

Number of Participants Who Participated in Photography Session

Illustration of the effectiveness of Sérum VERRUPRO® on the skin aspect before and after the treatment with photographs. A standardized photographs was taken at D0 an D35 in order to illustrate the effect of the product. No data were measured on these pictures. Number of Participants Who Participated in Photography Session

Time frame: Day 0, Day 35

Data from ClinicalTrials.gov

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