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

Primary Purpose

Chickenpox

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Poxclin Coolmousse
Sponsored by
Karo Pharma AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chickenpox

Eligibility Criteria

12 Months - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ewa Karamon, private practice

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Poxclin Coolmousse

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 27, 2023
Last Updated
September 7, 2023
Sponsor
Karo Pharma AB
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1. Study Identification

Unique Protocol Identification Number
NCT05732337
Brief Title
Open Clinical Investigation to Evaluate the Effectiveness and Safety of a Topical Medical Device.
Official Title
Prospective, Open Clinical Investigation to Evaluate the Effectiveness and Safety of a Topical Medical Device for the Treatment of Chickenpox Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
July 5, 2023 (Actual)
Study Completion Date
July 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karo Pharma AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chickenpox

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Poxclin Coolmousse
Arm Type
Other
Arm Description
A cooling mousse for application to the skin supplied in a 100 mL plastic bottle with a pump (a foamer)
Intervention Type
Device
Intervention Name(s)
Poxclin Coolmousse
Intervention Description
cooling mousse for application in the skin
Primary Outcome Measure Information:
Title
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.
Description
Children should be diagnosed with chickenpox.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
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.
Description
Children should be diagnosed with chickenpox.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ewa Karamon, private practice
City
Malbork
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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