Oily SkinNCT07848555
Dermal and Ophthalmological Acceptability and Comedogenicity Assessment of a Cosmetic Product
A study testing moisturizing cream in people with Oily Skin and Acne Prone 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 and ophthalmological safety of a cosmetic product and to assess its comedogenic and acnegenic potential in participants with oily or acne-prone skin. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Oily Skin, Acne Prone 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 28 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants aged 18 to 45 years.
- Participants with oily, acne-prone skin.
- 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).
- Normal ophthalmological examination, including slit-lamp evaluation.
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 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.
- Additional Ophthalmological Exclusion Criteria:
- Presence of entropion, ectropion, hordeolum, conjunctivitis, uveitis, or other active ocular diseases at the time of screening.
- Presence of corneal ulceration, blepharitis, meibomian gland dysfunction (meibomitis), pterygium, trichiasis, distichiasis, or other moderate to severe ocular conditions.
- 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 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 and Ophthalmological Acceptability and Comedogenic and Acnegenic Potential of a Cosmetic Product
The goal of this clinical trial is to evaluate the dermatological and ophthalmological safety of a cosmetic product and to assess its comedogenic and acnegenic potential in participants with oily or acne-prone skin. The main questions it aims to answer are:
- Does the investigational product demonstrate an absence of comedogenic potential under normal conditions of use?
- Does the investigational product demonstrate an absence of acnegenic potential under normal conditions of use?
- Does the investigational product demonstrate dermatological and ophthalmological acceptability?
- Does the investigational product present a low risk of irritation or discomfort during the study period?
Read more
Participants will:
- Apply the investigational cosmetic product to the face and body twice daily for 28 days.
- Undergo dermatological evaluations to assess skin tolerability and identify any signs of irritation or adverse reactions.
- Undergo ophthalmological evaluations to assess ocular tolerability.
- Undergo clinical assessments to evaluate the comedogenic and acnegenic potential of the investigational product.
The study will enroll 33 male and female participants aged 18 to 45 years with oily or acne-prone skin. Participants will be followed for 28 days while using the investigational product according to the study protocol.
- Conditions
- Oily Skin, Acne Prone Skin
- Being tested
- moisturizing cream
- Keywords
- Dermatological Safety, Ophthalmological Safety, Dermatological Acceptability, Ophthalmological Acceptability, Comedogenicity, Cosmetic Product, Acnegenicity, Oily Skin, Acne-Prone Skin, Skin Tolerability
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 28 days under normal conditions of use. The product will be evaluated for dermal and ophthalmological acceptability, as well as for its comedogenic and acnegenic potential, through clinical dermatological and ophthalmological assessments in participants with oily or acne-prone skin.
| Study group | Role | What they receive |
|---|---|---|
| Cosmetic Product Group | Experimental | Participants with oily or acne-prone skin will apply the investigational cosmetic product to the face and body twice daily for 28 days. Dermatological, ophthalmological, comedogenicity, and acnegenicity assessments will be performed 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.
Comedogenic and acnegenic potential assessed by clinical dermatological evaluation
Evaluation of the absence of comedogenic and acnegenic potential of the investigational product under normal conditions of use. Clinical dermatological assessments will be performed to identify the occurrence of comedones and acne lesions throughout the study period.
Measured: Baseline and Day 28
Secondary outcomes (2)
Dermatological Acceptability Assessed by Dermatologist Clinical Evaluation of Cutaneous Irritation Signs
Dermatological acceptability of the investigational product under normal conditions of use, assessed by a dermatologist through clinical evaluation of cutaneous irritation signs, including erythema, edema, dryness, desquamation, and other skin reactions at Baseline and Day 28.
Measured: Baseline and Day 28
Ophthalmological acceptability assessed by ophthalmologist clinical evaluation using slit-lamp examination
Participant-reported tolerability of the investigational product assessed through a standardized questionnaire evaluating sensations of burning, stinging, itching, tightness, tearing, ocular discomfort, or other subjective symptoms during the 28-day study period.
Measured: Day 28
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 completion28 Oct 2026 (estimated)
- Study completion28 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oily 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
- NCT07848555
- Sponsor's protocol ID
- 26-0197-05
- 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
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Dermal and Ophthalmological Acceptability and Comedogenic and Acnegenic Potential of a Cosmetic Product
- ClinicalTrials.gov ID
- NCT07848555
- Acronym / sponsor ID
- 26-0197-05
- Conditions
- Oily Skin, Acne Prone Skin
- Keywords
- Dermatological Safety, Ophthalmological Safety, Dermatological Acceptability, Ophthalmological Acceptability, Comedogenicity, Cosmetic Product, Acnegenicity, Oily 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
- 8 Sep 2026 (actual)
- Primary completion
- 28 Oct 2026 (estimated)
- Study completion
- 28 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 and ophthalmological safety of a cosmetic product and to assess its comedogenic and acnegenic potential in participants with oily or acne-prone skin. The main questions it aims to answer are:
- Does the investigational product demonstrate an absence of comedogenic potential under normal conditions of use?
- Does the investigational product demonstrate an absence of acnegenic potential under normal conditions of use?
- Does the investigational product demonstrate dermatological and ophthalmological acceptability?
- Does the investigational product present a low risk of irritation or discomfort during the study period?
Participants will:
- Apply the investigational cosmetic product to the face and body twice daily for 28 days.
- Undergo dermatological evaluations to assess skin tolerability and identify any signs of irritation or adverse reactions.
- Undergo ophthalmological evaluations to assess ocular tolerability.
- Undergo clinical assessments to evaluate the comedogenic and acnegenic potential of the investigational product.
The study will enroll 33 male and female participants aged 18 to 45 years with oily or acne-prone skin. Participants will be followed for 28 days while using the investigational product according to the study protocol.
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 creamParticipants with oily or acne-prone skin will apply the investigational cosmetic product to the face and body twice daily for 28 days. Dermatological, ophthalmological, comedogenicity, and acnegenicity assessments will be performed throughout the study period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female participants aged 18 to 45 years.
- Participants with oily, acne-prone skin.
- 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).
- Normal ophthalmological examination, including slit-lamp evaluation.
Key exclusion criteria (18 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 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 for 28 days under normal conditions of use. The product will be evaluated for dermal and ophthalmological acceptability, as well as for its comedogenic and acnegenic potential, through clinical dermatological and ophthalmological assessments in participants with oily or acne-prone skin. | Other | Cosmetic Product Group |
Primary outcome
Comedogenic and acnegenic potential assessed by clinical dermatological evaluation
Time frame: Baseline and Day 28
Evaluation of the absence of comedogenic and acnegenic potential of the investigational product under normal conditions of use. Clinical dermatological assessments will be performed to identify the occurrence of comedones and acne lesions throughout the study period.
2 secondary outcomes
Dermatological Acceptability Assessed by Dermatologist Clinical Evaluation of Cutaneous Irritation Signs
Time frame: Baseline and Day 28
Ophthalmological acceptability assessed by ophthalmologist clinical evaluation using slit-lamp examination
Time frame: Day 28
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.
- 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 Oily Skin and Acne Prone 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 5 inclusion and 18 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?
Comedogenic and acnegenic potential assessed by clinical dermatological evaluation (time frame: Baseline and Day 28). 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.