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.
Phase: NA
Conditions: Warts, Plantar Wart, Common Wart
Sponsor: Swiss Footcare Laboratories - Poderm Professional

 
 
 
PRM03-F-227_V7_EN  
Clinical investigational plan for MD 
 
 
 
 
 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 investigation plan #: 
23E2007 
NCT number:  
NCT06214559 
Date and version :  
V1.0 of 27.10.2023 
Title of the clinical investigation: 
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 
Sponsor: 
PODERM Professional 
Swiss Footcare Laboratories 
Chemin du Pré-Fleuri 1-3  
1228 Plan-les-ouates  
SWITZERLAND 
Development phase: 
Exploratory study 
Interventional 
MD without CE mark  
Objectives: 
Primary objective:  
To evaluate the effectiveness of Sérum VERRUPRO® in the 
treatment of warts, assess by the evolution of the wart diameter after 
35 days of treatment.  
 
Secondary objectives:  
- 
To evaluate the effectiveness of Sérum VERRUPRO® in the 
treatment of warts, assessed by the investigator , after 35 
days of treatment.  
- 
To evaluate the effectiveness of Sérum VERRUPRO® in the 
treatment of warts assess by the investigator clinical 
examination, after 35 days of treatment.  
- 
To illustrate the effectiveness of Sérum VERRUPRO® on the 
skin aspect before and after the treatment assess by 
photographs.   
- 
To evaluate the patient’s opinion of Sérum VERRUPRO® on 
the effectiveness, tolerance, and acceptability after 35 days 
of treatment.  
- 
To evaluate the safety and tolerance of Sérum VERRUPRO®  
Design: 
Prospective, multi center, before/after study.  
Planned Sample Size: 
33 included patients to expect result on 30 patients.  
60% of patients will be treated for a wart on their back of hands or 
fingers.  
40% of patients will be treated for a plantar wart.  
Number of investigational study 
sites: 
2 sites in Tunisia  
Inclusion criteria: 
1. Patient having given freely her/his informed, written consent.  
2. Patient having a good general health. 

 
 
 
PRM03-F-227_V7_EN  
Clinical investigational plan for MD 
 
3. Age: more than 18 years.  
4. 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. 
5. Patient being psychologically able to understand information 
and to give his/her consent. 
6. 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).  
7. Patient presenting wart of a size between 0,1 and 0,5 cm.  
8. 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: 
1. For plantar wart: wart on the point of support.  
2. Wart with keratosis.  
3. Wart in mosaic.  
4. Pregnant or nursing woman or planning a pregnancy during 
the investigation. 
5. Patient considered by the investigator likely to be non-
compliant with the protocol. 
6. Patient enrolled in another clinical trial during the test period. 
7. Patient having a known allergy or hypersensitivity to one of 
the constituents of the tested products. 
8. Patient with a condition or receiving a medication which, in 
the investigator’s judgment, put the patient at undue risk. 
9. 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 unguel growth … 
10. Patient with cutaneous pathology on studied zone other than 
warts. 
Investigational device: 
Name  
Galenic form 
Dosage 
Duration 
Administration route 
 
Sérum VERRUPRO®  
Liquid solution in bottle with a brush applicator  
Twice daily  
35 days  
Topical application 
Endpoints: 
Primary endpoint  
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 endpoints:  
- 
The global improvement of the wart will be assessed by the 
investigator after 35 days of treatment.  
 
- 
Clinical examination performed by the investigator to 
evaluate the roughness, thickness and the number of dermal 
papillae of the wart at D0 and 35 days after treatment.  
The effect of the product on these clinical parameters will be 
evaluated by a comparison before and after treatment.  
 
- 
Illustration of the effectiveness of Sérum VERRUPRO® on 
the skin aspect before and after the treatment with 
photographs.   

 
 
 
PRM03-F-227_V7_EN  
Clinical investigational plan for MD 
 
 
- 
Analysis of the answers to the patient questionnaire 
regarding effectiveness, tolerance, and acceptability of the 
investigational device 35 days after treatment. 
 
- 
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 will be assessed by the investigator at D0 
(before the product use) and D35 by a clinical examination. 
Study Procedures: 
Visit 1: informed consent, medical interview, collection of medical 
history and previous treatment, checking of the inclusion and 
exclusion criteria, patient inclusion, selection of the studied wart, 
clinical examination of the wart by the investigator, tolerance 
parameter evaluation, preparation of the wart by the investigator 
(removal of the stratum corneum if needed), photography of the 
selected wart, application of the product by the patient, distribution of 
daily log and product.  
 
Visit 2: clinical examination by the investigator, tolerance parameter 
evaluation, photography of the selected wart, assessment of the 
global improvement by the investigator, patient subjective 
questionnaire, product tolerance evaluation, record of AE, 
concomitant treatments, study end.  
Statistical methods: 
The following analysis populations will be studied and will be 
considered for the statistical analysis: 
- Safety population: any patient having used the 
investigational device.  
- ITT (Intent-to-Treat): any patient included in the study 
with at least a post-basal value.  
- PP population: any patient included having used at least 
once the investigational device and without any major 
deviation to the CIP.  
 
Descriptive analysis:  
Quantitative data will be summarized using adapted statistics 
(number of values, number of missing values, mean, standard 
deviation, minimum and maximum values) by time point.  
Categorical data will be summarized in frequency (N) and percentage 
(%). 
 
Primary endpoint:  
To evaluate the effectiveness of Sérum VERRUPRO® in the 
treatment of warts, assessed by the evolution of the wart diameter 
after 35 days of treatment.  
Clinical examination will 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 before and after treatment. 
 
A paired t-test will be carried out on the change from baseline 
outcome (D35-D0) to assess whether the mean value of the diameter 
of the wart decrease significantly from baseline.  
 
Secondary endpoints:  
- 
Global improvement Clinical examination of roughness, 
thickness and number of dermal papillae.  
- 
Subjective evaluation by the patient.  

 
 
 
PRM03-F-227_V7_EN  
Clinical investigational plan for MD 
 
- 
Tolerance by the investigator  
  
Each secondary endpoints listed above, will be summarized using 
adapted statistics.  
 
Safety assessment by collecting all the AEs occurred during the 
study will be summarized in frequency and percentage for the Safety 
population.  
 
Each statistical analysis test will be two tailed with a type I error set 
at α=0.05.  
 
Statistical software :  
SAS v9.4  
 
Foreseen study duration: 
Clinical investigation beginning: Q4 2023  
Clinical investigation end: Q2 2024 
Clinical investigation global duration: 4 months 
Duration by patient: 35 days 
 
 
FLOW-CHART 
 
Procedure 
Visit 1 
Day 0 
Visit 2 
Day 35 
Days 
D0 
D35±7  
Informed consent form signature 

 
Medical interview, medical history, previous and 
concomitant 
medications 
collection 
by 
the 
investigator 

 
Checking of the inclusion and exclusion criteria 

 
Patient inclusion  


Selection of the studied wart 

 
Clinical 
examination 
(diameter, 
roughness, 
thickness, dermal papillae) by the investigator 
*

Preparation of the selected wart (removal of the 
stratum corneum if needed) by the investigator 


Clinical examination for evaluation of product 
tolerance by the investigator  
*

Photograph of the selected wart 
* (after removal of 
the stratum 
corneum)

Treatment application by the patient  
 (under investigator control at the site on D0 
then at home)
Patient subjective evaluation questionnaire 


Global improvement evaluation by the investigator 


Distribution of daily log and products  


AE and concomitant treatment collection 
 

Study end 
 

 
*Before treatment application