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

Chickenpox Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05732337
• Other study ID #: 22E3464/ PXC_001
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chickenpox

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