Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06214559
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2023-12-28
Brief Title:
Evaluate the Effectiveness and the Safety of a Medical Device in the Treatment of Common Warts and Plantar Warts
Sponsor:
Swiss Footcare Laboratories - Poderm Professional
Organization:
Swiss Footcare Laboratories - Poderm Professional
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 01 and 05cm and present since less than 6 months will be included to reach this objective
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 01 and 05cm 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 01 and 05cm and present since less than 6 months will be included to reach this objective
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 01 and 05cm and present since less than 6 months will be included to reach this objective
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None