Pediatric cosmetic product safety and acceptability in healthy children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, single-blind trial will apply the investigational moisturizing cream to the face and body twice daily for 21 days in up to 33 healthy pediatric participants. Participants will undergo clinical evaluations to monitor skin tolerability and look for irritation or adverse reactions, while guardians report any discomfort sensations during use. The study aims to determine if the product is well tolerated and acceptable for pediatric use under typical conditions. Safety data will focus on skin irritation, adverse events, and overall tolerability in a broad pediatric age range.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male and female participants aged from 7 days to 14 years.
* Participants whose parent(s) and/or legal guardian(s) agree to comply with all study procedures and attend the study site on the scheduled dates and times for assessments.
* Parent(s) and/or legal guardian(s) able to understand the study requirements and provide written informed consent by signing the Informed Consent Form (ICF) prior to the performance of any study-specific procedures.
* When applicable, participants able to understand and provide assent by signing the Assent Form, according to their age, maturity, and level of understanding.
* Inclusion of at least one newborn participant.

Exclusion Criteria:

* Use of anti-inflammatory, immunosuppressive, or antihistamine medications within 3 weeks prior to screening.
* Skin conditions or marks in the test area that may interfere with the evaluation of potential skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
* History of atopy or allergic reactions to cosmetic products.
* Active skin diseases and/or lesions (localized or widespread) in the assessment area.
* Immunosuppression due to medication use or active disease.
* Uncontrolled endocrine disorders.
* Known history of or suspected intolerance to products of the same category.
* Intense sun exposure within 15 days prior to assessment.
* Aesthetic or dermatological treatments within 4 weeks prior to assessment.
* Any other condition that, in the investigator's opinion, may reasonably justify exclusion from the study

Where it's running

• Grupo Medcin
  Osasco, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Layane Melody Da Silva Reis Cavalcante
• Email: layane.reis@brainfarma.ind.br
• Phone: +55 (11) 4507-2183

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.