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OpenTrials
Completed

NCT Number: NCT05732337

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

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

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Key information

Age range

12 month–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ewa Karamon, private practice

Malbork, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Poxclin Coolmousse

Device

cooling mousse for application in the skin

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.

    Time frame: 3 days

    Children should be diagnosed with chickenpox.

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.

    Time frame: 7 days

    Children should be diagnosed with chickenpox.

Sponsors and collaborators

Lead sponsor

Karo Pharma AB

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2023
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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