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NCT07839104From ClinicalTrials.govRecruiting

Pediatric Acceptability Evaluation of a Cosmetic Product

Clinical Evaluation of Pediatric Acceptability of a Cosmetic Product

  • Pediatric Safety

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Brainfarma Industria Química e Farmacêutica S/A
Enrolment target
33
Started
21 October 2026
Main results due
7 December 2026
Study sites
1
Registry updated
24 September 2026

Can you take part?

  • Ages 7 days to 14 years.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • Grupo Medcin

    Osasco, São Paulo, Brazil

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07839104. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Pediatric Acceptability Evaluation of a Cosmetic Product | Trialion