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

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

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

Study Overview

• Status: Completed
• Conditions: Chickenpox
• Intervention / Treatment: Device: Poxclin Coolmousse

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diana Zeneli; Phone Number: 0031614706949; Email: diana.pasho@karo.com

Study Locations

• Poland
  • Malbork, Poland
    • Ewa Karamon, private practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 11 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karo Pharma AB

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Actual): July 5, 2023
• Study Completion (Actual): July 5, 2023

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Chickenpox
• Other Study ID Numbers: 22E3464/ PXC_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No