Sensitive SkinNCT07848347
Dermal Acceptability Evaluation in Sensitive Skin
A study testing moisturizing cream in people with Sensitive Skin, 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 participants with sensitive skin. The main questions it aims to answer are: Does the investigational product demonstrate dermatological acceptability in participants with sensitive skin under normal… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sensitive Skin
- 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
- 8 Sep 2026to 19 Oct 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female participants aged 18 years or older.
- Participants with sensitive skin, clinically confirmed by a positive Stinging Test.
- Participants with any skin type (combination, oily, dry, or normal skin).
- Intact skin in the assessment area.
- Willingness to comply with all study procedures and attend the study site on the scheduled dates and times for assessments.
- Ability to understand the study requirements, provide written informed consent, and sign the Informed Consent Form (ICF).
Who cannot join
- Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study, when applicable.
- 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.
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- Uncontrolled endocrine disorders.
- Relevant medical history or current evidence of alcohol or substance abuse.
- 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 Dermal Acceptability in Participants With Sensitive Skin
The goal of this clinical trial is to evaluate the dermatological safety and acceptability of a cosmetic product in participants with sensitive skin. The main questions it aims to answer are:
- Does the investigational product demonstrate dermatological acceptability in participants with sensitive skin under normal conditions of use?
- Does the investigational product present a low risk of skin irritation?
- What discomfort sensations, if any, are reported by participants with sensitive skin during product use?
Read more
Participants will:
- Apply the investigational product to the face and body twice daily under normal conditions of use.
- Undergo clinical dermatological evaluations to assess signs of irritation and product tolerability.
- Report any discomfort sensations experienced during the study period. The study will enroll 33 healthy male and female participants aged 18 years or older with sensitive skin confirmed by a positive Stinging Test. This is a single-center, single-blind clinical trial designed to evaluate the dermatological safety of the investigational product through clinical dermatological assessments under real-world conditions of use.
- Conditions
- Sensitive Skin
- Being tested
- moisturizing cream
- Keywords
- Sensitive Skin, Dermatological Safety, Dermatological Acceptability, Skin Tolerability, Skin Irritation, Stinging Test, Cosmetic Product, Sensitive Skin Syndrome
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 under normal conditions of use. The product will be evaluated for dermatological acceptability and tolerability in participants with sensitive skin confirmed by a positive Stinging Test. Clinical dermatological assessments will be performed throughout the study period to evaluate signs of irritation and participant-reported discomfort sensations.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product Group | Experimental | Participants with sensitive skin confirmed by a positive Stinging Test will apply the investigational cosmetic product to the face and body twice daily under normal conditions of use. Dermatological evaluations will be performed to assess product tolerability, irritation, and discomfort sensations throughout the study period. Receives: Other: moisturizing cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Dermatological Signs and Symptoms Assessed by Clinical Dermatological Evaluation
Dermatological evaluation of the occurrence and severity of erythema, edema, desquamation, pruritus, burning sensation, vesicles, papules, irritation, or other clinical signs and symptoms of adverse events. Severity was assessed using a 4-point scale ranging from 0 to 3, where 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Higher scores indicate greater severity of dermatological signs and symptoms and therefore a worse outcome.
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 posted30 Sep 2026
- Study start8 Sep 2026
- Primary completion19 Oct 2026 (estimated)
- Study completion19 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitive SkinStudies 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
- NCT07848347
- Sponsor's protocol ID
- 26-0197-04
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Dermal Acceptability in Participants With Sensitive Skin
- ClinicalTrials.gov ID
- NCT07848347
- Acronym / sponsor ID
- 26-0197-04
- Conditions
- Sensitive Skin
- Keywords
- Sensitive Skin, Dermatological Safety, Dermatological Acceptability, Skin Tolerability, Skin Irritation, Stinging Test, Cosmetic Product, Sensitive Skin Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/AIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 19 Oct 2026 (estimated)
- Study completion
- 19 Oct 2026 (estimated)
- First posted
- 30 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 participants with sensitive skin. The main questions it aims to answer are:
- Does the investigational product demonstrate dermatological acceptability in participants with sensitive skin under normal conditions of use?
- Does the investigational product present a low risk of skin irritation?
- What discomfort sensations, if any, are reported by participants with sensitive skin during product use?
Participants will:
- Apply the investigational product to the face and body twice daily under normal conditions of use.
- Undergo clinical dermatological evaluations to assess signs of irritation and product tolerability.
- Report any discomfort sensations experienced during the study period. The study will enroll 33 healthy male and female participants aged 18 years or older with sensitive skin confirmed by a positive Stinging Test. This is a single-center, single-blind clinical trial designed to evaluate the dermatological safety of the investigational product through clinical dermatological assessments under real-world 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 |
|---|---|---|
| Investigational Product Group | Experimental | Other: moisturizing creamParticipants with sensitive skin confirmed by a positive Stinging Test will apply the investigational cosmetic product to the face and body twice daily under normal conditions of use. Dermatological evaluations will be performed to assess product tolerability, irritation, and discomfort sensations throughout the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female participants aged 18 years or older.
- Participants with sensitive skin, clinically confirmed by a positive Stinging Test.
- Participants with any skin type (combination, oily, dry, or normal skin).
- Intact skin in the assessment area.
- Willingness to comply with all study procedures and attend the study site on the scheduled dates and times for assessments.
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study, when applicable.
- 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.
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 under normal conditions of use. The product will be evaluated for dermatological acceptability and tolerability in participants with sensitive skin confirmed by a positive Stinging Test. Clinical dermatological assessments will be performed throughout the study period to evaluate signs of irritation and participant-reported discomfort sensations. | Other | Investigational Product Group |
Primary outcome
Severity of Dermatological Signs and Symptoms Assessed by Clinical Dermatological Evaluation
Time frame: Day 21
Dermatological evaluation of the occurrence and severity of erythema, edema, desquamation, pruritus, burning sensation, vesicles, papules, irritation, or other clinical signs and symptoms of adverse events. Severity was assessed using a 4-point scale ranging from 0 to 3, where 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Higher scores indicate greater severity of dermatological signs and symptoms and therefore a worse outcome.
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 30 Sep 2026.
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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 Sensitive Skin, 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 6 inclusion and 12 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 30 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?
Severity of Dermatological Signs and Symptoms Assessed by Clinical Dermatological Evaluation (time frame: Day 21). 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 30 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.