ChickenpoxNCT05732337
Open Clinical Investigation to Evaluate the Effectiveness and Safety of a Topical Medical Device.
A study testing Poxclin Coolmousse in people with Chickenpox, run by Karo Pharma AB at 1 site in Poland.
Trial summary
The primary endpoint is the change of the itching score after 3 days of the product use in comparison to the basal value. Read more about this study
- Who is it for?
- Ages 12 months to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Chickenpox
- What is being tested?
- Poxclin Coolmousse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePoland
- Study dates
- 30 Jan 2023to 5 Jul 2023
- Phase
- Interventional
- 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 12 months to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Female and/or male
- Aged between 12 months to 11 years
- phototype: I to IV
- Subject or parent(s)/legal representative(s) must be registered with health social security or health social insurance.
- Parent(s)/legal representative(s) having signed their written Informed Consent form (ICF) for their children's participation in the study
- Subject and / or parent(s)/legal representative(s) able to understand the language used in the investigation centre and the information given
- Subject or parent(s)/legal representative(s) able to comply with the protocol, follow protocol's constraints and specific requirements and able to follow the medical recommendation regarding the pathology and its requirements (treatment, social eviction etc)
- Subjects presenting non severe and non complicated chicken pox
Who cannot join
- Subject or parent(s)/legal representative(s) who is (are) unable to understand the information (for linguistic or psychiatric reasons) and to give his/her (their) consent to his/ her (their child) participation
- Subject taking part or planning to participate in another clinical trial during the study in the same or another investigation centre
- Subject or parent(s)/legal representative(s) deprived of freedom by administrative or legal decision or under guardianship
- Subject or parent(s)/legal representative(s) admitted in a sanitary or social facility
- Subjects planning a hospitalization during the study
- Severe or complicated chicken pox (surinfection, profuse eruption, pneumonia, etc)
Show all 12Show fewer
- Having an acute, chronic, or progressive disease or dermatological condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- Having personal medical history liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- Being under any treatment for a severe or complicated chicken pox considered by the Investigator liable to interfere with the study data or incompatible with the study requirements (antiviral (Herviran) or antibiotics...)
- Having taken any previous treatment considered by the Investigator liable to interfere with the study data or incompatible with the study requirements
- Systemic antibiotics within 1 week before the inclusion or required during the study
- Systemic immunosuppressive treatment within 6 months before the inclusion or required during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Open Clinical Investigation to Evaluate the Effectiveness and Safety of a Topical Medical Device for the Treatment of Chickenpox Symptoms
The primary endpoint is the change of the itching score after 3 days of the product use in comparison to the basal value.
- Conditions
- Chickenpox
- Being tested
- Poxclin Coolmousse
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poxclin CoolmousseDevice
cooling mousse for application in the skin
| Study group | Role | What they receive |
|---|---|---|
| Poxclin Coolmousse | Other | A cooling mousse for application to the skin supplied in a 100 mL plastic bottle with a pump (a foamer) Receives: Device: Poxclin Coolmousse |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of PoxClin® CoolMousse in relieving itching associated with chickenpox (using 5-point scale,"none (0)" to "severe (4)" ) will be evaluated after 3 days.
Children should be diagnosed with chickenpox.
Measured: 3 days
Secondary outcomes (1)
The efficacy of the PoxClin® CoolMousse in relieving itch during chickenpox (using 5 point scale, "none (0)" to "severe (4)"): itching) will be evaluated after 7 days.
Children should be diagnosed with chickenpox.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start30 Jan 2023
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChickenpoxStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To determine the efficacy of PoxClin® CoolMousse in relieving itching associated with chickenpox after 3 days of use (using 5-point scale)
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karo Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732337
- Sponsor's protocol ID
- 22E3464/ PXC_001
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open Clinical Investigation to Evaluate the Effectiveness and Safety of a Topical Medical Device for the Treatment of Chickenpox Symptoms
- ClinicalTrials.gov ID
- NCT05732337
- Acronym / sponsor ID
- 22E3464/ PXC_001
- Conditions
- Chickenpox
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Karo Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 17 Feb 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.
The primary endpoint is the change of the itching score after 3 days of the product use in comparison to the basal value.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To determine the efficacy of PoxClin® CoolMousse in relieving itching associated with chickenpox after 3 days of use (using 5-point scale)
| Arm | Type | Receives |
|---|---|---|
| Poxclin Coolmousse | Other | Device: Poxclin CoolmousseA cooling mousse for application to the skin supplied in a 100 mL plastic bottle with a pump (a foamer) |
Who may qualify
- Ages
- 12 months to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Female and/or male
- Aged between 12 months to 11 years
- phototype: I to IV
- Subject or parent(s)/legal representative(s) must be registered with health social security or health social insurance.
- Parent(s)/legal representative(s) having signed their written Informed Consent form (ICF) for their children's participation in the study
Key exclusion criteria (12 listed)
- Subject or parent(s)/legal representative(s) who is (are) unable to understand the information (for linguistic or psychiatric reasons) and to give his/her (their) consent to his/ her (their child) participation
- Subject taking part or planning to participate in another clinical trial during the study in the same or another investigation centre
- Subject or parent(s)/legal representative(s) deprived of freedom by administrative or legal decision or under guardianship
- Subject or parent(s)/legal representative(s) admitted in a sanitary or social facility
- Subjects planning a hospitalization during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Poxclin Coolmoussecooling mousse for application in the skin | Device | Poxclin Coolmousse |
Primary outcome
The efficacy of PoxClin® CoolMousse in relieving itching associated with chickenpox (using 5-point scale,"none (0)" to "severe (4)" ) will be evaluated after 3 days.
Time frame: 3 days
Children should be diagnosed with chickenpox.
1 secondary outcome
The efficacy of the PoxClin® CoolMousse in relieving itch during chickenpox (using 5 point scale, "none (0)" to "severe (4)"): itching) will be evaluated after 7 days.
Time frame: 7 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 8 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poxclin Coolmousse in people with Chickenpox, run by Karo Pharma AB at 1 site in Poland.
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 8 inclusion and 12 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 8 Sep 2023. 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 Poland. 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?
The efficacy of PoxClin® CoolMousse in relieving itching associated with chickenpox (using 5-point scale,"none (0)" to "severe (4)" ) will be evaluated after 3 days. (time frame: 3 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 8 Sep 2023.