Clinical trial NCT06214559: Evaluate the Effectiveness and the Safety of a Medical Device in the Treatment of Common Warts and Plantar Warts.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Warts
Plantar Wart
Common Wart
Lead sponsor: Swiss Footcare Laboratories - Poderm Professional
Sponsor class: INDUSTRY
First posted: 2024-01-19
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diameter of the Wart
timeFrame: Day 0, Day 35
Secondary outcomes:
measure: Global Improvement of the Wart
timeFrame: Day 35
measure: Roughness of the Wart
timeFrame: Day 0, Day 35
measure: Thickness of the Wart
timeFrame: Day 0, Day 35
measure: Number of Dermal Papillae
timeFrame: Day 0, Day 35
measure: Number of Participants Who Participated in Photography Session
timeFrame: Day 0, Day 35
measure: Patient Evaluation
timeFrame: Day 35
measure: Adverse Event
timeFrame: Day 0, Day 35
measure: Product Tolerance
timeFrame: Day 0, Day 35
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: L'Activité Privée Complémentaire (APC) Habib Thameur hospital
city: Tunis
country: Tunisia
facility: Private practice
Study officials:
References: