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

Molluscum Contagiosum Clinical Trial

— SERENITE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05680181
• Other study ID #: 2022-A01503-40
• Status: Recruiting
• Start date: January 20, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2023
• Source: Laboratoire Dermatologique ACM
• Contact: Renaud URBINELLI
• Phone: 0756882093
• Email: contact[@]clin-experts.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Molluscum Contagiosum

Locations

Country	Name	City	State
France	Multiple locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Laboratoire Dermatologique ACM	Clin-Experts

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage change in the number of lesions compared to D0		at day 45 +- 2 days
Secondary	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
Secondary	Percentage of children in whom new lesions appeared since inclusion according to the parents		at day 45 +- 2 days
Secondary	Time of disappearance of the initial lesions (judgment of the parents)		up to 45 days
Secondary	Disappearance of pruritus since inclusion	Yes/non Yes/no	at day 45 +- 2 days
Secondary	Occurrence of contamination of a subject of the family since inclusion	Yes/no	at day 45 +- 2 days
Secondary	Compliance with the terms of use of the prescribed treatment	Yes/no	at day 45 +- 2 days
Secondary	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
Secondary	Assessment of tolerance	Tolerance is measured by adverse events reported	at day 45 +- 2 days