An interventional study of moisturizing cream in Pediatric Safety, sponsored by Brainfarma Industria Química e Farmacêutica S/A. Recruiting at 1 site in Brazil. Open to participants aged 7 Days to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Brainfarma Industria Química e Farmacêutica S/A (part of Hypera Pharma) · Not applicable, Interventional, and Other
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:
Participants will:
Brainfarma Industria Química e Farmacêutica S/A is the lead sponsor of 15 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 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.
Time frame: Day 21
Plan to share: No — No plan has been established to share individual participant data (IPD) collected during this study. Participant confidentiality and privacy will be protected in accordance with applicable regulations and institutional policies.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2026, 1 month later.
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