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Completed

NCT Number: 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

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.

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Key information

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple locations

Multiple Locations, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of children healed healing defined by a decrease of more than 90% in the number of lesions present at D0.

    Time frame: at day 45 +- 2 days

Secondary outcomes

  1. Percentage change in the number of lesions compared to D0

    Time frame: at day 45 +- 2 days

  2. Percentage of patients according to the reduction in the number of lesions compared to D0

    Time frame: at day 45 +- 2 days

    (> 90%, 90% 75%; 74%-50%; 49%-25%; < 25%)

  3. Percentage of children in whom new lesions appeared since inclusion according to the parents

    Time frame: at day 45 +- 2 days

  4. Time of disappearance of the initial lesions (judgment of the parents)

    Time frame: up to 45 days

  5. Disappearance of pruritus since inclusion

    Time frame: at day 45 +- 2 days

    Yes/non Yes/no

  6. Occurrence of contamination of a subject of the family since inclusion

    Time frame: at day 45 +- 2 days

    Yes/no

  7. Compliance with the terms of use of the prescribed treatment

    Time frame: at day 45 +- 2 days

    Yes/no

  8. Assessment of the ability to use the treatment

    Time frame: at day 45 +- 2 days

    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)

  9. Assessment of tolerance

    Time frame: at day 45 +- 2 days

    Tolerance is measured by adverse events reported

Sponsors and collaborators

Lead sponsor

Laboratoire Dermatologique ACM

Industry

Collaborators

  • Clin-Experts

Registry information

Official study 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

Acronym: SERENITE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 11, 2023
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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