Trial Outcomes & Findings for Evaluate the Effectiveness and the Safety of a Medical Device in the Treatment of Common Warts and Plantar Warts. (NCT NCT06214559)
NCT ID: NCT06214559
Last Updated: 2025-03-05
Results Overview
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.
COMPLETED
NA
33 participants
Day 0, Day 35
2025-03-05
Participant Flow
Recruitment in two private prictise in Tunisia from 19.02.2024 to 16.07.2024
Not applicable. No enrolled patient were excluded from the study before groups assignments
Participant milestones
| Measure |
Serum VERRUPRO
To be applied twice a day
Sérum VERRUPRO: To be applied twice a day
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Serum VERRUPRO
n=33 Participants
To be applied twice a day
Sérum VERRUPRO: To be applied twice a day
|
|---|---|
|
Age, Continuous
|
36.15 years
STANDARD_DEVIATION 14.12 • n=33 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=33 Participants
|
|
Region of Enrollment
Tunisia
|
33 participants
n=33 Participants
|
PRIMARY outcome
Timeframe: Day 0, Day 35Population: On ITT population
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.
Outcome measures
| Measure |
Serum VERRUPRO
n=33 Participants
To be applied twice a day
Sérum VERRUPRO: To be applied twice a day
|
|---|---|
|
Diameter of the Wart
|
-0.12 cm
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Day 35Population: On per protocol population
The global improvement of the wart will be assessed by the investigator after 35 days of treatment.
Outcome measures
| Measure |
Serum VERRUPRO
n=32 Participants
To be applied twice a day
Sérum VERRUPRO: To be applied twice a day
|
|---|---|
|
Global Improvement of the Wart
Beginning of improvement
|
15 Participants
|
|
Global Improvement of the Wart
Significant improvement
|
12 Participants
|
|
Global Improvement of the Wart
Total recovery
|
4 Participants
|
|
Global Improvement of the Wart
No change
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 0, Day 35Population: On per protocol population
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).
Outcome measures
| Measure |
Serum VERRUPRO
n=32 Participants
To be applied twice a day
Sérum VERRUPRO: To be applied twice a day
|
|---|---|
|
Roughness of the Wart
|
-1.4 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Day 0, Day 35Population: On per protocol population
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)
Outcome measures
| Measure |
Serum VERRUPRO
n=32 Participants
To be applied twice a day
Sérum VERRUPRO: To be applied twice a day
|
|---|---|
|
Thickness of the Wart
|
-1.5 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Day 0, Day 35Population: On per protocol population
The effect of the product on these clinical parameters will be evaluated by a comparison before and after treatment.
Outcome measures
| Measure |
Serum VERRUPRO
n=32 Participants
To be applied twice a day
Sérum VERRUPRO: To be applied twice a day
|
|---|---|
|
Number of Dermal Papillae
|
-4.1 number of dermal papillae
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Day 0, Day 35Population: Only photographs for illustration, no data analysed. 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
Outcome measures
| Measure |
Serum VERRUPRO
n=32 Participants
To be applied twice a day
Sérum VERRUPRO: To be applied twice a day
|
|---|---|
|
Number of Participants Who Participated in Photography Session
|
32 Participants
|
SECONDARY outcome
Timeframe: Day 35Population: On per protocol population, are you globally statisfied with the product
Analysis of the answers to the patient questionnaire regarding effectiveness, tolerance, and acceptability of the investigational device 35 days after treatment.
Outcome measures
| Measure |
Serum VERRUPRO
n=32 Participants
To be applied twice a day
Sérum VERRUPRO: To be applied twice a day
|
|---|---|
|
Patient Evaluation
totally agree
|
8 Participants
|
|
Patient Evaluation
agree
|
9 Participants
|
|
Patient Evaluation
neutral
|
11 Participants
|
|
Patient Evaluation
disagree
|
4 Participants
|
|
Patient Evaluation
totally disagree
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0, Day 35Population: No adverse event during the study
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.
Outcome measures
| Measure |
Serum VERRUPRO
n=33 Participants
To be applied twice a day
Sérum VERRUPRO: To be applied twice a day
|
|---|---|
|
Adverse Event
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0, Day 35Population: on per protocol population, evaluation of local tolerance on redness / edema / Desquamation and dryness. here is presented redness at D35
Product tolerance will be assessed by the investigator at D0 (before the product use) and D35 by a clinical examination.
Outcome measures
| Measure |
Serum VERRUPRO
n=32 Participants
To be applied twice a day
Sérum VERRUPRO: To be applied twice a day
|
|---|---|
|
Product Tolerance
None
|
18 Participants
|
|
Product Tolerance
Very mild
|
9 Participants
|
|
Product Tolerance
Mild
|
3 Participants
|
|
Product Tolerance
Moderate
|
1 Participants
|
|
Product Tolerance
Severe
|
1 Participants
|
Adverse Events
Serum VERRUPRO
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place