An observational study in Molluscum Contagiosum, sponsored by Laboratoire Dermatologique ACM. Completed at 1 site in France. Open to participants aged 2 Years to 10 Years. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Laboratoire Dermatologique ACM · Observational
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.
Child seen in private dermatology consultation for suspected molluscum contagiosum
Child aged 2 to 10 years old :
Exclusion Criteria:
Doubt about the diagnosis of molluscum contagiosum Molluscum contagiosum surge already treated Immunocompromised child Atopic eczema in outbreak Lesions around the eye
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
Percentage change in the number of lesions compared to D0
Time frame: 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%)
Time frame: at day 45 +- 2 days
Percentage of children in whom new lesions appeared since inclusion according to the parents
Time frame: at day 45 +- 2 days
Time of disappearance of the initial lesions (judgment of the parents)
Time frame: up to 45 days
Disappearance of pruritus since inclusion
Yes/non Yes/no
Time frame: at day 45 +- 2 days
Occurrence of contamination of a subject of the family since inclusion
Yes/no
Time frame: at day 45 +- 2 days
Compliance with the terms of use of the prescribed treatment
Yes/no
Time frame: 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)
Time frame: at day 45 +- 2 days
Assessment of tolerance
Tolerance is measured by adverse events reported
Time frame: at day 45 +- 2 days
Plan to share: Undecided
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Laboratoire Dermatologique ACM