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

NCT ID: NCT05732337

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2023-07-05

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.

Conditions

Chickenpox

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Poxclin Coolmousse

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

Group Type: OTHER

Poxclin Coolmousse

Intervention Type: DEVICE

cooling mousse for application in the skin

Interventions

Poxclin Coolmousse

cooling mousse for application in the skin

Intervention Type: DEVICE

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karo Pharma AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ewa Karamon, private practice

Malbork, , Poland

Countries

Poland

Other Identifiers

22E3464/ PXC_001

Identifier Type: -

Identifier Source: org_study_id