Study of a Cohort of Children With Molluscum Contagiosum (MC) Treated With a 5% Solution of Potassium Hydroxide (Molutrex®) Applied Locally to the Skin (SERENITE)

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

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 2017/745 RDM, he is a class IIa medical device. In accordance with Regulation (EU) 2017/745 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.

Study Overview

• Status: Recruiting
• Conditions: Molluscum Contagiosum

• Study Type: Observational
• Enrollment (Estimated): 95

Contacts and Locations

• Study Contact: Name: Renaud URBINELLI; Phone Number: 0756882093; Email: contact@clin-experts.fr

Study Locations

• France
  • Multiple Locations, France
    • Recruiting
    • Multiple locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Child seen in private dermatology consultation for suspected molluscum contagiosum

Description

Inclusion Criteria:

Child aged 2 to 10 years old :

• Ambulatory
• Seen in dermatology consultation for molluscum contagiosum
• For which a treatment with a 5% solution of potassium hydroxide (Molutrex®) in local cutaneous application has been decided by the dermatologist as monotherapy
• Not treated for their molluscum contagiosum in the previous month
• For which one of the parents gives their written consent to participate

Exclusion Criteria:

Doubt about the diagnosis of molluscum contagiosum Molluscum contagiosum surge already treated Immunocompromised child Atopic eczema in outbreak Lesions around the eye

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of children healed healing defined by a decrease of more than 90% in the number of lesions present at D0.	at day 45 +- 2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in the number of lesions compared to D0		at day 45 +- 2 days
Percentage of patients according to the reduction in the number of lesions compared to D0	(> 90%, 90% 75%; 74%-50%; 49%-25%; < 25%)	at day 45 +- 2 days
Percentage of children in whom new lesions appeared since inclusion according to the parents		at day 45 +- 2 days
Time of disappearance of the initial lesions (judgment of the parents)		up to 45 days
Disappearance of pruritus since inclusion	Yes/non Yes/no	at day 45 +- 2 days
Occurrence of contamination of a subject of the family since inclusion	Yes/no	at day 45 +- 2 days
Compliance with the terms of use of the prescribed treatment	Yes/no	at day 45 +- 2 days
Assessment of the ability to use the treatment	Assessed with 4 questions : Did you find the instructions easy or difficult to understand (Very difficult;Difficult;Neither easy nor difficult;Easy;Very easy) Did you find the bottle easy or difficult to open (Very difficult;Difficult;Neither easy nor difficult;Easy;Very easy) Did you find the product easy or difficult to apply (Very difficult;Difficult;Neither easy nor difficult;Easy;Very easy) Did you find the bottle with the cap with the brush easy or difficult to close (Very difficult;Difficult;Neither easy nor difficult;Easy;Very easy)	at day 45 +- 2 days
Assessment of tolerance	Tolerance is measured by adverse events reported	at day 45 +- 2 days

Collaborators and Investigators

• Sponsor: Laboratoire Dermatologique ACM
• Collaborators: Clin-Experts
• Investigators: Principal Investigator: Eric CAUMES, Hotel Dieu de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: December 24, 2022
• First Posted (Actual): January 11, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Observational study; Medical device; Molluscum Contagiosum
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Poxviridae Infections; Molluscum Contagiosum
• Other Study ID Numbers: 2022-A01503-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No