Common Wart, Plantar Wart, Warts
Conditions
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.
Interventions
DEVICESérum VERRUPRO
To be applied twice a day
Sponsors
Swiss Footcare Laboratories - Poderm Professional
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diameter of the Wart | Day 0, Day 35 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Roughness of the Wart | Day 0, Day 35 | 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). |
| Thickness of the Wart | Day 0, Day 35 | 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) |
| Number of Dermal Papillae | Day 0, Day 35 | The effect of the product on these clinical parameters will be evaluated by a comparison before and after treatment. |
| Global Improvement of the Wart | Day 35 | The global improvement of the wart will be assessed by the investigator after 35 days of treatment. |
| Patient Evaluation | Day 35 | Analysis of the answers to the patient questionnaire regarding effectiveness, tolerance, and acceptability of the investigational device 35 days after treatment. |
| Adverse Event | Day 0, Day 35 | 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. |
| Product Tolerance | Day 0, Day 35 | Product tolerance will be assessed by the investigator at D0 (before the product use) and D35 by a clinical examination. |
| Number of Participants Who Participated in Photography Session | Day 0, Day 35 | 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 |
Countries
Tunisia
Participant flow
Recruitment details
Recruitment in two private prictise in Tunisia from 19.02.2024 to 16.07.2024
Pre-assignment details
Not applicable. No enrolled patient were excluded from the study before groups assignments
Participants by arm
| Arm | Count |
|---|---|
| Serum VERRUPRO To be applied twice a day
Sérum VERRUPRO: To be applied twice a day | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Serum VERRUPRO | — |
|---|---|---|
| Age, Continuous | 36.15 years STANDARD_DEVIATION 14.12 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Tunisia | 33 participants | — |
| Sex: Female, Male Female | 23 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
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.
Time frame: Day 0, Day 35
Population: On ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serum VERRUPRO | Diameter of the Wart | -0.12 cm | Standard Error 0.14 |
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.
Time frame: Day 0, Day 35
Population: No adverse event during the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Serum VERRUPRO | Adverse Event | 0 Participants |
Secondary
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
Population: On per protocol population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Serum VERRUPRO | Global Improvement of the Wart | Beginning of improvement | 15 Participants |
| Serum VERRUPRO | Global Improvement of the Wart | Significant improvement | 12 Participants |
| Serum VERRUPRO | Global Improvement of the Wart | Total recovery | 4 Participants |
| Serum VERRUPRO | Global Improvement of the Wart | No change | 1 Participants |
Secondary
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
Population: On per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serum VERRUPRO | Number of Dermal Papillae | -4.1 number of dermal papillae | Standard Deviation 3.8 |
Secondary
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
Population: Only photographs for illustration, no data analysed. Number of Participants Who Participated in Photography Session
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Serum VERRUPRO | Number of Participants Who Participated in Photography Session | 32 Participants |
Secondary
Patient Evaluation
Analysis of the answers to the patient questionnaire regarding effectiveness, tolerance, and acceptability of the investigational device 35 days after treatment.
Time frame: Day 35
Population: On per protocol population, are you globally statisfied with the product
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Serum VERRUPRO | Patient Evaluation | totally agree | 8 Participants |
| Serum VERRUPRO | Patient Evaluation | agree | 9 Participants |
| Serum VERRUPRO | Patient Evaluation | neutral | 11 Participants |
| Serum VERRUPRO | Patient Evaluation | disagree | 4 Participants |
| Serum VERRUPRO | Patient Evaluation | totally disagree | 0 Participants |
Secondary
Product Tolerance
Product tolerance will be assessed by the investigator at D0 (before the product use) and D35 by a clinical examination.
Time frame: Day 0, Day 35
Population: on per protocol population, evaluation of local tolerance on redness / edema / Desquamation and dryness. here is presented redness at D35
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Serum VERRUPRO | Product Tolerance | None | 18 Participants |
| Serum VERRUPRO | Product Tolerance | Very mild | 9 Participants |
| Serum VERRUPRO | Product Tolerance | Mild | 3 Participants |
| Serum VERRUPRO | Product Tolerance | Moderate | 1 Participants |
| Serum VERRUPRO | Product Tolerance | Severe | 1 Participants |
Secondary
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
Population: On per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serum VERRUPRO | Roughness of the Wart | -1.4 score on a scale | Standard Deviation 1 |
Secondary
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
Population: On per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serum VERRUPRO | Thickness of the Wart | -1.5 score on a scale | Standard Deviation 0.8 |