Prospective, Open Clinical Investigation to Evaluate the Effectiveness and Safety of a Topical Medical Device for the Treatment of Chickenpox Symptoms

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 11
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Poland
Ewa Karamon, private practice
Malbork
Time Frame
Start Date: 2023-01-30
Completion Date: 2023-07-05
Participants
Target number of participants: 28
Treatments
Other: Poxclin Coolmousse
A cooling mousse for application to the skin supplied in a 100 mL plastic bottle with a pump (a foamer)
Related Therapeutic Areas
Sponsors
Leads: Karo Pharma AB

This content was sourced from clinicaltrials.gov

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