Molluscum ContagiosumSERENITENCT05680181
Study of a Cohort of Children With Molluscum Contagiosum (MC) Treated With a 5% Solution of Potassium Hydroxide (Molutrex®) Applied Locally to the Skin
An observational study of Molluscum Contagiosum, run by Laboratoire Dermatologique ACM at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Molluscum Contagiosum
- How many people
- 109 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2023to 26 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Child seen in private dermatology consultation for suspected molluscum contagiosum
Who may be able to join
- 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
Who cannot join
- Doubt about the diagnosis of molluscum contagiosum Molluscum contagiosum surge already treated Immunocompromised child Atopic eczema in outbreak Lesions around the eye
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Medical subject headings
- Molluscum Contagiosum
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children healed healing defined by a decrease of more than 90% in the number of lesions present at D0.
Measured: at day 45 +- 2 days
Secondary outcomes (9)
Percentage change in the number of lesions compared to D0
Measured: 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%)
Measured: at day 45 +- 2 days
Percentage of children in whom new lesions appeared since inclusion according to the parents
Measured: at day 45 +- 2 days
Time of disappearance of the initial lesions (judgment of the parents)
Measured: up to 45 days
Disappearance of pruritus since inclusion
Yes/non Yes/no
Measured: at day 45 +- 2 days
Occurrence of contamination of a subject of the family since inclusion
Yes/no
Measured: at day 45 +- 2 days
Compliance with the terms of use of the prescribed treatment
Yes/no
Measured: 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)
Measured: at day 45 +- 2 days
Assessment of tolerance
Tolerance is measured by adverse events reported
Measured: at day 45 +- 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start20 Jan 2023
- Primary completion26 Jan 2024
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molluscum ContagiosumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire Dermatologique ACM
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Responsible party
- Sponsor
- Investigators
- Eric CAUMES, Principal investigator, Hôtel Dieu de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680181
- Sponsor's protocol ID
- 2022-A01503-40
- Acronym
- SERENITE
- Status last verified
- May 2024
- First submitted
- 16 Dec 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05680181
- Acronym / sponsor ID
- SERENITE / 2022-A01503-40
- Conditions
- Molluscum Contagiosum
- Keywords
- Molluscum Contagiosum, Observational study, Medical device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Laboratoire Dermatologique ACMIndustry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Child seen in private dermatology consultation for suspected molluscum contagiosum
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Doubt about the diagnosis of molluscum contagiosum Molluscum contagiosum surge already treated Immunocompromised child Atopic eczema in outbreak Lesions around the eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
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
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
Time frame: at day 45 +- 2 days
Occurrence of contamination of a subject of the family since inclusion
Time frame: at day 45 +- 2 days
Compliance with the terms of use of the prescribed treatment
Time frame: at day 45 +- 2 days
Assessment of the ability to use the treatment
Time frame: at day 45 +- 2 days
Assessment of tolerance
Time frame: at day 45 +- 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric CAUMES principal investigator
Hôtel Dieu de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Molluscum Contagiosum, run by Laboratoire Dermatologique ACM at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.