Pediatric Acceptability Evaluation of a Cosmetic Product
ConditionPediatric Safety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-14
SponsorBrainfarma Industria Química e Farmacêutica S/A
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
moisturizing cream
Other interventionA 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.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Cosmetic Product GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pediatric dermatological acceptability assessed by pediatrician clinical evaluation
Dermatological acceptability of the investigational product in pediatric participants under normal conditions of use, assessed by a pediatrician through clinical evaluation of skin integrity, signs of irritation, and the occurrence of adverse events at Baseline and Day 21.
Time frame
Baseline and Day 212
Participant-reported tolerability assessed through daily use diary
Tolerability of the investigational product assessed through information recorded by parents or legal guardians in the daily use diary, including reports of discomfort sensations, signs of intolerance, and adverse events during the 21-day product use period.
Time frame
Day 21Sponsors and contacts
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Source ClinicalTrials.gov