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Pediatric Acceptability Evaluation of a Cosmetic Product

Sponsor: Brainfarma Industria Química e Farmacêutica S/A • ClinicalTrials.gov ID: NCT07839104

Registry updated: 2026-09-24

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Description

The goal of this clinical trial is to evaluate the dermatological safety and acceptability of a cosmetic product in healthy pediatric participants. The main questions it aims to answer are: * Does the investigational product demonstrate pediatric acceptability under normal conditions of use? * Does the investigational product present a low risk of skin irritation in the pediatric population? * Are any discomfort sensations reported during product use? Participants will: * Apply the investigational product to the face and body twice daily for 21 days. * Undergo clinical evaluations to assess skin tolerability and identify any signs of irritation or adverse reactions. * Be monitored for potential discomfort sensations throughout the study period. The study will enroll 33 healthy male and female participants aged from 7 days to 14 years. This is a single-center, single-blind clinical trial designed to evaluate the safety of the investigational product through clinical assessments under normal conditions of use.

Interventions

moisturizing cream (Other)
A cosmetic product applied to the face and body twice daily for 21 days under normal conditions of use. The product will be evaluated for pediatric acceptability and tolerability through clinical assessments of skin irritation and discomfort in healthy pediatric participants.

Eligibility criteria

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

Conditions

Pediatric Safety

Locations

Grupo Medcin — Osasco, São Paulo, Brazil

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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