Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05680181
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2022-12-16
Brief Title:
Study of a Cohort of Children With Molluscum Contagiosum MC Treated With a 5 Solution of Potassium Hydroxide Molutrex Applied Locally to the Skin
Sponsor:
Laboratoire Dermatologique ACM
Organization:
Laboratoire Dermatologique ACM
Study Overview
Official Title:
Multicenter National Observational and Prospective Study of a Cohort of Children With Molluscum Contagiosum MC Treated With a 5 Solution of Potassium Hydroxide Molutrex Applied Locally to the Skin
Status:
COMPLETED
Status Verified Date:
2024-05
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:
SERENITE
Brief Summary:
Molutrex a 5 potassium hydroxide solution for topical application to the skin Molutrex is intended for the superficial treatment of certain types of warts molluscum contagiosum and is composed of potassium hydroxide 5 purified water With regard to the 2017745 RDM he is a class IIa medical device In accordance with Regulation EU 2017745 of the European Parliament and of the Council of April 5 2017 relating to medical devices as part of the Molutrex Post-Marketing Monitoring Plan the objective of this study is to have data on the performance safety and suitability for real-life use of Molutrex in a prospective cohort of patients with molluscum contagiosum
Since molluscum contagiosum is most prevalent in children and potassium hydroxide is used very little in adults because most often they are immunocompromised patients requiring other antiviral treatments the study will be conducted in children aged 2 to 10 years This population represents the majority of patients treated with Molutrex although the product can be used in adults The study includes 2 visits the objective of the study being to evaluate the percentage of children healed at 45 days healing defined by a reduction of more than 90 in the number of lesions present at inclusion in the study
Since molluscum contagiosum is most prevalent in children and potassium hydroxide is used very little in adults because most often they are immunocompromised patients requiring other antiviral treatments the study will be conducted in children aged 2 to 10 years This population represents the majority of patients treated with Molutrex although the product can be used in adults The study includes 2 visits the objective of the study being to evaluate the percentage of children healed at 45 days healing defined by a reduction of more than 90 in the number of lesions present at inclusion in the study
Detailed Description:
None
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