NCT05732337

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2023

Completed
Last Updated

September 8, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

January 27, 2023

Last Update Submit

September 7, 2023

Conditions

Chickenpox

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

    7 days

Study Arms (1)

Poxclin Coolmousse

OTHER

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

Device: Poxclin Coolmousse

Interventions

Poxclin CoolmousseDEVICE

cooling mousse for application in the skin

Poxclin Coolmousse

Eligibility Criteria

Age12 Months - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewa Karamon, private practice

Malbork, Poland

Location

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: To determine the efficacy of PoxClin® CoolMousse in relieving itching associated with chickenpox after 3 days of use (using 5-point scale)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 17, 2023

Study Start

January 30, 2023

Primary Completion

July 5, 2023

Study Completion

July 5, 2023

Last Updated

September 8, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)