Clinical trial NCT05680181: Study of a Cohort of Children With Molluscum Contagiosum (MC) Treated With a 5% Solution of Potassium Hydroxide (Molutrex®) Applied Locally to the Skin
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Molluscum Contagiosum
Keywords: Molluscum Contagiosum
Observational study
Medical device
Lead sponsor: Laboratoire Dermatologique ACM
Sponsor class: INDUSTRY
Collaborators: name: Clin-Experts
First posted: 2023-01-11
Enrollment: 109
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child seen in private dermatology consultation for suspected molluscum contagiosum

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of children healed healing defined by a decrease of more than 90% in the number of lesions present at D0.
timeFrame: at day 45 +- 2 days
Secondary outcomes:
measure: Percentage change in the number of lesions compared to D0
timeFrame: at day 45 +- 2 days
measure: Percentage of patients according to the reduction in the number of lesions compared to D0
timeFrame: at day 45 +- 2 days
measure: Percentage of children in whom new lesions appeared since inclusion according to the parents
timeFrame: at day 45 +- 2 days
measure: Time of disappearance of the initial lesions (judgment of the parents)
timeFrame: up to 45 days
measure: Disappearance of pruritus since inclusion
timeFrame: at day 45 +- 2 days
measure: Occurrence of contamination of a subject of the family since inclusion
timeFrame: at day 45 +- 2 days
measure: Compliance with the terms of use of the prescribed treatment
timeFrame: at day 45 +- 2 days
measure: Assessment of the ability to use the treatment
timeFrame: at day 45 +- 2 days
measure: Assessment of tolerance
timeFrame: at day 45 +- 2 days
Other outcomes:
Locations:
city: Multiple Locations
country: France
facility: Multiple locations
Study officials:
affiliation: Hôtel Dieu de Paris
name: Eric CAUMES
role: PRINCIPAL_INVESTIGATOR
References: