An interventional study of Sérum VERRUPRO in Warts, Plantar Wart and Common Wart, sponsored by Swiss Footcare Laboratories - Poderm Professional. Completed at 2 sites in Tunisia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-05.
Sponsored by Swiss Footcare Laboratories - Poderm Professional · Not applicable, Interventional, and Treatment
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.
171 studies on the registry are indexed under Warts; 35 are open to participants now.
This study's enrollment of 33 is below the median of 70 across 155 interventional studies indexed under Warts.
Browse Warts studies →Swiss Footcare Laboratories - Poderm Professional is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 should use an accepted 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 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, patient , 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To be applied twice a day
Device: Sérum VERRUPRO
To be applied twice a day
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
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
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
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
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
Recruitment in two private prictise in Tunisia from 19.02.2024 to 16.07.2024
| Milestone | Serum VERRUPRO |
|---|---|
| Started | 33 |
| Completed | 33 |
| Not completed | 0 |
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.
| cm | Serum VERRUPRO |
|---|---|
| Diameter of the Wart | -0.12 ± 0.14 |
The global improvement of the wart will be assessed by the investigator after 35 days of treatment.
| Participants | Serum VERRUPRO |
|---|---|
| Beginning of improvement | 15 |
| Significant improvement | 12 |
| Total recovery | 4 |
| No change | 1 |
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).
| score on a scale | Serum VERRUPRO |
|---|---|
| Roughness of the Wart | -1.4 ± 1.0 |
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)
| score on a scale | Serum VERRUPRO |
|---|---|
| Thickness of the Wart | -1.5 ± 0.8 |
The effect of the product on these clinical parameters will be evaluated by a comparison before and after treatment.
| number of dermal papillae | Serum VERRUPRO |
|---|---|
| Number of Dermal Papillae | -4.1 ± 3.8 |
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
| Participants | Serum VERRUPRO |
|---|---|
| Number of Participants Who Participated in Photography Session | 32 |
Analysis of the answers to the patient questionnaire regarding effectiveness, tolerance, and acceptability of the investigational device 35 days after treatment.
| Participants | Serum VERRUPRO |
|---|---|
| totally agree | 8 |
| agree | 9 |
| neutral | 11 |
| disagree | 4 |
| totally disagree | 0 |
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.
| Participants | Serum VERRUPRO |
|---|---|
| Adverse Event | 0 |
Product tolerance will be assessed by the investigator at D0 (before the product use) and D35 by a clinical examination.
| Participants | Serum VERRUPRO |
|---|---|
| None | 18 |
| Very mild | 9 |
| Mild | 3 |
| Moderate | 1 |
| Severe | 1 |
Collected over 35 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Serum VERRUPRO | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Age, Continuous(years) | Serum VERRUPRO |
|---|---|
| Mean | 36.15 ± 14.12 |
| Sex: Female, Male(Participants) | Serum VERRUPRO |
|---|---|
| Female | 23 |
| Male | 10 |
| Race and Ethnicity Not Collected(Participants) | Serum VERRUPRO |
|---|
| Region of Enrollment(participants) | Serum VERRUPRO |
|---|---|
| Tunisia | 33 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2024 to primary completion in Aug 2024, 6 months.
Results were first posted in Mar 2025, 6 months after primary completion.
Of 28 interventional studies with no phase under Warts, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Swiss Footcare Laboratories - Poderm Professional