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CompletedNCT05732337Updated Sep 8, 2023

Open Clinical Investigation to Evaluate the Effectiveness and Safety of a Topical Medical Device.

An interventional study of Poxclin Coolmousse in Chickenpox, sponsored by Karo Pharma AB. Completed at 1 site in Poland. Open to participants aged 12 Months to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-08.

Sponsored by Karo Pharma AB · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
12 Months to 11 Years
Sex
All
01

Study summary

The primary endpoint is the change of the itching score after 3 days of the product use in comparison to the basal value.

02

Conditions studied

  • Chickenpox

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03

In context

Chickenpox

156 studies on the registry are indexed under Chickenpox; 26 are open to participants now.

This study's enrollment of 28 is below the median of 475 across 128 interventional studies indexed under Chickenpox.

Browse Chickenpox studies →

Lead sponsor

Karo Pharma AB is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Female and/or male
  2. Aged between 12 months to 11 years
  3. phototype: I to IV
  4. Subject or parent(s)/legal representative(s) must be registered with health social security or health social insurance.
  5. Parent(s)/legal representative(s) having signed their written Informed Consent form (ICF) for their children's participation in the study
  6. Subject and / or parent(s)/legal representative(s) able to understand the language used in the investigation centre and the information given
  7. 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)
  8. Subjects presenting non severe and non complicated chicken pox

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. Subject taking part or planning to participate in another clinical trial during the study in the same or another investigation centre
  3. Subject or parent(s)/legal representative(s) deprived of freedom by administrative or legal decision or under guardianship
  4. Subject or parent(s)/legal representative(s) admitted in a sanitary or social facility
  5. Subjects planning a hospitalization during the study
  6. Severe or complicated chicken pox (surinfection, profuse eruption, pneumonia, etc)
  7. 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
  8. 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
  9. 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...)
  10. Having taken any previous treatment considered by the Investigator liable to interfere with the study data or incompatible with the study requirements
  11. Systemic antibiotics within 1 week before the inclusion or required during the study
  12. Systemic immunosuppressive treatment within 6 months before the inclusion or required during the study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Other
    Poxclin Coolmousse

    A cooling mousse for application to the skin supplied in a 100 mL plastic bottle with a pump (a foamer)

    Device: Poxclin Coolmousse

Interventions

  • DevicePoxclin Coolmousse

    cooling mousse for application in the skin

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 7 days

07

Study locations

1 site
  • Ewa Karamon, private practice
    Malbork, Poland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2023 to primary completion in Jul 2023, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2023
First posted
Feb 17, 2023
StartActual
Jan 30, 2023
Primary completionActual
Jul 5, 2023
CompletionActual
Jul 5, 2023
Last update
Sep 8, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05732337
Lead sponsor
Karo Pharma AB
Responsible party
Sponsor
First posted
Feb 17, 2023
Start date
Jan 30, 2023
Primary completion
Jul 5, 2023
Completion
Jul 5, 2023
Last update
Sep 8, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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