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

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

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

Conditions
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Chickenpox

Intervention / Treatment
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* Device: Poxclin Coolmousse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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) 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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Poxclin Coolmousse<br>A cooling mousse for application to the skin supplied in a 100 mL plastic bottle with a pump (a foamer) | Device: Poxclin Coolmousse<br>* cooling mousse for application in the skin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |