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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05732337
Other study ID # 22E3464/ PXC_001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 30, 2023
Est. completion date July 5, 2023

Study information

Verified date January 2023
Source Karo Pharma AB
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date July 5, 2023
Est. primary completion date July 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 11 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Poxclin Coolmousse
cooling mousse for application in the skin

Locations

Country Name City State
Poland Ewa Karamon, private practice Malbork

Sponsors (1)

Lead Sponsor Collaborator
Karo Pharma AB

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 days
Secondary 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. 7 days
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