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

NCT05680181 | Completed

• 1 other identifier: 2022-A01503-40
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Molluscum Contagiosum

Keywords

Molluscum Contagiosum; Observational study; Medical device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

  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

  at day 45 +- 2 days

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Child seen in private dermatology consultation for suspected molluscum contagiosum

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Laboratoire Dermatologique ACM: lead
• Clin-Experts: collaborator

Study Sites (1)

Multiple locations

Multiple Locations, France

Location

MeSH Terms

Conditions

Molluscum Contagiosum

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Eric CAUMES

  Hôtel Dieu de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 11, 2023
• Study Start: January 20, 2023
• Primary Completion: January 26, 2024
• Study Completion: January 26, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

FR (1)