Sensitive SkinADOPSNCT07771998
Dermal and Ophthalmological Acceptability Assessment in Sensitive Skin
A study testing Blancy Pro in people with Sensitive Skin, run by Brainfarma Industria Química e Farmacêutica S/A at 1 site in Brazil.
Trial summary
This is a single-center, single-blind clinical study designed to evaluate the safety of the investigational product through dermatological and ophthalmological clinical assessments. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sensitive Skin
- What is being tested?
- Blancy Pro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jul 2026to 3 Sep 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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female participants aged 18 to 60 years.
- Participants with any skin type, with at least 25% representation of each skin type.
- Participants with sensitive skin, clinically confirmed by the Stinging Test.
- Intact skin in the assessment area.
- Willingness to comply with all study procedures and attend scheduled visits and assessments.
- Ability to understand, 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.
- Use of anti-inflammatory, immunosuppressive, or antihistamine medications within 3 weeks prior to screening.
- Skin marks or conditions in the study area that may interfere with the evaluation of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
- History of atopic disease or allergy to cosmetic products.
- Active skin diseases and/or lesions in the assessment area or elsewhere on the body.
- Immunosuppression due to medication use or active disease.
Show all 17Show fewer
- Uncontrolled endocrine disorders.
- Relevant medical history or current evidence of alcohol or drug abuse.
- Known history or suspected intolerance to products of the same category as the investigational product.
- 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 justify exclusion from the study. Reasons for exclusion will be documented in the clinical record.
- Participants with entropion, ectropion, hordeolum (stye), conjunctivitis, uveitis, or other active ocular diseases at screening.
- Participants with corneal ulceration, blepharitis, meibomitis, pterygium, trichiasis, distichiasis, or other moderate to severe ocular disorders.
- Initiation of contact lens use within 1 week prior to screening.
- Use of ophthalmic products, including eye drops and/or ophthalmic ointments, within 3 weeks prior to screening.
- Any other ocular condition that, in the investigator's opinion, may justify exclusion from the study. Reasons for exclusion will be documented in the clinical record.
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: Evaluation of the Dermal and Ophthalmological Acceptability of Blancy Pro in Subjects With Sensitive Skin
This is a single-center, single-blind clinical study designed to evaluate the safety of the investigational product through dermatological and ophthalmological clinical assessments. A total of 33 female participants, aged 18 to 60 years, with a clinical diagnosis of sensitive skin confirmed by the Stinging Test, will be enrolled. Safety evaluations will be performed throughout the study period using standardized clinical assessments.
- Conditions
- Sensitive Skin
- Being tested
- Blancy Pro
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blancy ProOther
Blancy Pro is a cosmetic product evaluated for safety and tolerability in female participants with clinically confirmed sensitive skin through dermatological and ophthalmological assessments.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product Mostrar mais linhas | Experimental | Female participants aged 18 to 60 years with clinically confirmed sensitive skin will receive the investigational product and undergo dermatological and ophthalmological safety assessments throughout the study. Receives: Other: Blancy Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatological and Ophthalmological Safety Assessment
Evaluation of the safety of the investigational product under real-world conditions of use by assessing the absence of dermatological and ophthalmological irritation and capturing participant-reported discomfort sensations in individuals with sensitive skin.
Measured: Baseline (D0); D21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start20 Jul 2026
- Primary completion3 Sep 2026 (estimated)
- Study completion3 Sep 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
- Investigators
- Sergio Schalka, Principal investigator, Grupo Medcin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771998
- Sponsor's protocol ID
- 26-0161-03
- Acronym
- ADOPS
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2026
- Last updated
- 11 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Dermal and Ophthalmological Acceptability of Blancy Pro in Subjects With Sensitive Skin
- ClinicalTrials.gov ID
- NCT07771998
- Acronym / sponsor ID
- ADOPS / 26-0161-03
- Conditions
- Sensitive Skin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/AIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 3 Sep 2026 (estimated)
- Study completion
- 3 Sep 2026 (estimated)
- First posted
- 19 Aug 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.
This is a single-center, single-blind clinical study designed to evaluate the safety of the investigational product through dermatological and ophthalmological clinical assessments. A total of 33 female participants, aged 18 to 60 years, with a clinical diagnosis of sensitive skin confirmed by the Stinging Test, will be enrolled. Safety evaluations will be performed throughout the study period using standardized clinical assessments.
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 Mostrar mais linhas | Experimental | Other: Blancy ProFemale participants aged 18 to 60 years with clinically confirmed sensitive skin will receive the investigational product and undergo dermatological and ophthalmological safety assessments throughout the study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female participants aged 18 to 60 years.
- Participants with any skin type, with at least 25% representation of each skin type.
- Participants with sensitive skin, clinically confirmed by the Stinging Test.
- Intact skin in the assessment area.
- Willingness to comply with all study procedures and attend scheduled visits and assessments.
Key exclusion criteria (17 listed)
- Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study.
- Use of anti-inflammatory, immunosuppressive, or antihistamine medications within 3 weeks prior to screening.
- Skin marks or conditions in the study area that may interfere with the evaluation of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
- History of atopic disease or allergy to cosmetic products.
- Active skin diseases and/or lesions in the assessment area or elsewhere on the body.
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 |
|---|---|---|
| Blancy ProBlancy Pro is a cosmetic product evaluated for safety and tolerability in female participants with clinically confirmed sensitive skin through dermatological and ophthalmological assessments. | Other | Investigational Product Mostrar mais linhas |
Primary outcome
Dermatological and Ophthalmological Safety Assessment
Time frame: Baseline (D0); D21
Evaluation of the safety of the investigational product under real-world conditions of use by assessing the absence of dermatological and ophthalmological irritation and capturing participant-reported discomfort sensations in individuals with sensitive skin.
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 11 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.
Sergio Schalka principal investigator
Grupo Medcin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blancy Pro 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 17 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 11 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 Beatriz Santos Arnoni (+55 (11) 94742 3610, beatriz.arnoni@medcin.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermatological and Ophthalmological Safety Assessment (time frame: Baseline (D0); D21). 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 11 Sep 2026.