Clinical trial NCT05732337: Open Clinical Investigation to Evaluate the Effectiveness and Safety of a Topical Medical Device.
Official title: Prospective, Open Clinical Investigation to Evaluate the Effectiveness and Safety of a Topical Medical Device for the Treatment of Chickenpox Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chickenpox
Lead sponsor: Karo Pharma AB
Sponsor class: INDUSTRY
First posted: 2023-02-17
Enrollment: 28
Sex: ALL
Minimum age (years): 12
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To determine the efficacy of PoxClin® CoolMousse in relieving itching associated with chickenpox after 3 days of use (using 5-point scale)
Primary purpose: TREATMENT

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


Eligibility criteria: 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:

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

Primary outcomes:
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.
timeFrame: 3 days
Secondary outcomes:
measure: 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.
timeFrame: 7 days
Other outcomes:
Locations:
city: Malbork
country: Poland
facility: Ewa Karamon, private practice
Study officials:
References: