Pediatric SafetyNCT07839104
Pediatric Acceptability Evaluation of a Cosmetic Product
A study testing moisturizing cream in people with Pediatric Safety, run by Brainfarma Industria Química e Farmacêutica S/A at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 days to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Safety
- What is being tested?
- moisturizing cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Oct 2026to 7 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Grupo Medcin
Osasco, São Paulo, 06023-070
Camila Canale, +55 (11) 98343 6952, camila.canale.ext@medcin.com.br
Sergio Schalka
About this study
Official title: Clinical Evaluation of Pediatric Acceptability of a Cosmetic Product
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?
Read more
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
- Being tested
- moisturizing cream
- Keywords
- Pediatric Acceptability, Pediatric Safety, Dermatological Safety, Skin Tolerability, Cosmetic Product, Infants, Children, Skin Irritation, Pediatric Skin Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moisturizing creamOther
Also called Hydraporin AI Creme
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: moisturizing cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start21 Oct 2026 (estimated)
- Primary completion7 Dec 2026 (estimated)
- Study completion7 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839104
- Sponsor's protocol ID
- 26-0197-03
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Pediatric Acceptability of a Cosmetic Product
- ClinicalTrials.gov ID
- NCT07839104
- Acronym / sponsor ID
- 26-0197-03
- Conditions
- Pediatric Safety
- Keywords
- Pediatric Acceptability, Pediatric Safety, Dermatological Safety, Skin Tolerability, Cosmetic Product, Infants, Children, Skin Irritation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/AIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2026 (estimated)
- Primary completion
- 7 Dec 2026 (estimated)
- Study completion
- 7 Dec 2026 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cosmetic Product Group | Experimental | Other: moisturizing creamHealthy 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. |
Who may qualify
- Ages
- 7 days to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| moisturizing creamAlso: Hydraporin AI CremeA 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. | Other | Cosmetic Product Group |
Primary outcome
Pediatric dermatological acceptability assessed by pediatrician clinical evaluation
Time frame: Baseline and Day 21
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.
Participant-reported tolerability assessed through daily use diary
Time frame: Day 21
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moisturizing cream in people with Pediatric Safety, run by Brainfarma Industria Química e Farmacêutica S/A at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Layane Melody Da Silva Reis Cavalcante (+55 (11) 4507-2183, layane.reis@brainfarma.ind.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric dermatological acceptability assessed by pediatrician clinical evaluation (time frame: Baseline and Day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.