Pediatric Acceptability Evaluation of a Cosmetic Product

NCT07839104 | Recruiting

• 1 other identifier: 26-0197-03
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Safety

Keywords

Pediatric Acceptability; Pediatric Safety; Dermatological Safety; Skin Tolerability; Cosmetic Product; Infants; Children; Skin Irritation; Pediatric Skin Care

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and Day 21

• 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.

  Day 21

Study Arms (1)

Cosmetic Product Group

EXPERIMENTAL

Healthy male and female pediatric participants aged from 7 days to 14 years will apply the investigational cosmetic product to the face and body twice daily for 21 days under normal conditions of use. Clinical evaluations will be performed throughout the study period to assess dermatological acceptability, skin tolerability, signs of irritation, and potential discomfort sensations.

Other: moisturizing cream

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.

Also known as: Hydraporin AI Creme

Cosmetic Product Group

Eligibility Criteria

• Age: 7 Days - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brainfarma Industria Química e Farmacêutica S/A: lead

Study Sites (1)

Grupo Medcin

Osasco, São Paulo, 06023-070, Brazil

RECRUITING

Central Study Contacts

Layane Melody Da Silva Reis Cavalcante

CONTACT

+55 (11) 4507-2183; layane.reis@brainfarma.ind.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 24, 2026
• Study Start (Estimated): October 21, 2026
• Primary Completion (Estimated): December 7, 2026
• Study Completion (Estimated): December 7, 2026
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)