XerosisNCT07820943
Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function
A study testing moisturizing cream in people with Xerosis and Dry 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 efficacy of a moisturizing product in participants with moderate to severe xerosis of the lower limbs. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- What is being tested?
- moisturizing cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Sep 2026to 17 Nov 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female participants aged 36 to 65 years.
- Participants presenting moderate to severe xerosis of the lower limbs, corresponding to grades 2 or 3 on the Overall Dry Skin Score (ODS) scale, confirmed by clinical evaluation.
- Participants presenting a stratum corneum hydration index between 35 and 55 arbitrary units (AU), as measured by corneometry on the forearm during the eligibility assessment.
- Participants considered healthy by the investigator, with no medical conditions or use of medications that could pose an undue risk or interfere with the study results.
- 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, antihistamine, or any other medication that, in the investigator's opinion, may interfere with skin condition assessments or study outcomes.
- Presence of skin marks in the test area that may interfere with clinical or instrumental evaluations of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
- Presence of active atopic dermatitis, eczema, or other dermatoses that may interfere with evaluation of the test area.
- Active localized or generalized skin diseases and/or lesions in the assessment area that, in the investigator's opinion, may compromise participation in the study.
- Immunosuppression due to medication use or active disease.
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- Uncontrolled endocrine disorders.
- Presence of significant vascular alterations in the lower limbs, such as severe venous insufficiency, significant edema, lymphedema, or ulcers that may interfere with study assessments.
- 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 the baseline assessment.
- Aesthetic or dermatological treatments within 4 weeks prior to the baseline assessment.
- Procedures that may temporarily alter skin condition in the test area, such as exfoliation or hair removal, within the timeframe specified by the study protocol.
- Any other condition that, in the investigator's opinion, may pose a risk to the participant, interfere with protocol compliance, or compromise the interpretation of study results.
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, Subjective, and Instrumental Evaluation of Dermatological Acceptability and Efficacy in Improving Dryness, Hydration, and Skin Barrier Function in Participants With Xerosis
The goal of this clinical trial is to evaluate the dermatological safety and efficacy of a moisturizing product in participants with moderate to severe xerosis of the lower limbs. The main questions it aims to answer are:
- Does the investigational product demonstrate dermatological acceptability and absence of irritation under real-world conditions of use?
- Does the investigational product improve skin hydration after single and repeated applications?
- Does the investigational product improve skin barrier recovery and strengthen skin barrier function?
- How do participants perceive the performance and efficacy of the investigational product?
Read more
Participants will:
- Apply the investigational moisturizing product twice daily for 28 days.
- Undergo clinical dermatological evaluations to assess skin tolerability and potential irritation.
- Undergo instrumental assessments of skin hydration using a Corneometer® and skin barrier function using a Tewameter®.
- Complete questionnaires regarding product performance and perceived efficacy.
The study will enroll 22 male and female participants aged 35 to 65 years with clinically confirmed moderate to severe xerosis of the lower limbs.
- Being tested
- moisturizing cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moisturizing creamOther
A topical moisturizing product intended for the management of xerosis. The product will be applied twice daily to the lower limbs for 28 consecutive days. Its dermatological acceptability, effects on skin hydration, and effects on skin barrier recovery and strengthening will be evaluated through clinical, subjective, and instrumental assessments, including Corneometer® and Tewameter® measurements.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product Group | Experimental | Participants with moderate to severe xerosis of the lower limbs will apply the investigational moisturizing product twice daily for 28 days. Dermatological, subjective, and instrumental assessments will be performed to evaluate skin tolerability, hydration, and skin barrier function. Receives: Other: moisturizing cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatological Acceptability Assessed by Clinical Dermatological Evaluation
Dermatological acceptability of the investigational product under real-world conditions of use, including the assessment of signs of skin irritation and participant-reported discomfort sensations. Evaluations will be performed by a dermatologist throughout the study period.
Measured: Baseline and Day 28
Secondary outcomes (6)
Skin Hydration Assessed by Corneometer®
Evaluation of skin hydration following a single application of the investigational product using Corneometer®. Skin hydration will be measured in arbitrary units (AU), with higher values indicating greater skin hydration.
Measured: Immediately after application, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 12 hours, 24 hours, and 48 hours after a single application.
Skin Barrier Recovery Assessed by Tewameter® Following Tape Stripping
Evaluation of skin barrier recovery following barrier disruption induced by tape stripping and a single application of the investigational product. Skin barrier function will be assessed using Tewameter® measurements of transepidermal water loss (TEWL). Lower TEWL values indicate improved skin barrier recovery and function.
Measured: Immediately after application, 1 hour, 2 hours, and 4 hours after a single application.
Perceived Product Performance Assessed by a Perceived Efficacy Questionnaire Following Tape Stripping
Evaluation of the performance and attributes of the investigational product using a perceived efficacy questionnaire following skin barrier disruption induced by tape stripping and a single application of the product. Participants will report the intensity of symptoms and sensations, such as burning sensation, using response categories ranging from "Absent" to "Very Intense."
Measured: Immediately after application, 1 hour, and 2 hours after a single application.
Skin Barrier Strengthening Assessed by Tewameter®
Evaluation of skin barrier strengthening following continuous use of the investigational product. Skin barrier function will be assessed using Tewameter® measurements of transepidermal water loss (TEWL) after 7 and 28 days of product use. Lower TEWL values indicate improved skin barrier function and strengthening of the skin barrier.
Measured: Day 7 and Day 28
Skin Hydration Assessed by Corneometer®
Evaluation of the efficacy of the investigational product in improving skin hydration following continuous use. Skin hydration will be measured using Corneometer® and reported in arbitrary units (AU). Higher values indicate greater skin hydration and a better outcome.
Measured: Day 7 and Day 28
Perceived Product Performance Assessed by a Perceived Efficacy Questionnaire
Evaluation of the performance and attributes of the investigational product using a perceived efficacy questionnaire after 7 and 28 days of product use. Responses will be recorded using a 5-category agreement scale ranging from "Strongly Disagree" to "Strongly Agree."
Measured: Day 7 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start14 Sep 2026
- Primary completion17 Nov 2026 (estimated)
- Study completion17 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerosisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT07820943
- Sponsor's protocol ID
- 26-0197-06
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 2 Nov 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Subjective, and Instrumental Evaluation of Dermatological Acceptability and Efficacy in Improving Dryness, Hydration, and Skin Barrier Function in Participants With Xerosis
- ClinicalTrials.gov ID
- NCT07820943
- Acronym / sponsor ID
- 26-0197-06
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/AIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- 17 Nov 2026 (estimated)
- Study completion
- 17 Nov 2026 (estimated)
- First posted
- 15 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 efficacy of a moisturizing product in participants with moderate to severe xerosis of the lower limbs. The main questions it aims to answer are:
- Does the investigational product demonstrate dermatological acceptability and absence of irritation under real-world conditions of use?
- Does the investigational product improve skin hydration after single and repeated applications?
- Does the investigational product improve skin barrier recovery and strengthen skin barrier function?
- How do participants perceive the performance and efficacy of the investigational product?
Participants will:
- Apply the investigational moisturizing product twice daily for 28 days.
- Undergo clinical dermatological evaluations to assess skin tolerability and potential irritation.
- Undergo instrumental assessments of skin hydration using a Corneometer® and skin barrier function using a Tewameter®.
- Complete questionnaires regarding product performance and perceived efficacy.
The study will enroll 22 male and female participants aged 35 to 65 years with clinically confirmed moderate to severe xerosis of the lower limbs.
Study design
- Primary purpose
- Treatment
- 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 moderate to severe xerosis of the lower limbs will apply the investigational moisturizing product twice daily for 28 days. Dermatological, subjective, and instrumental assessments will be performed to evaluate skin tolerability, hydration, and skin barrier function. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female participants aged 36 to 65 years.
- Participants presenting moderate to severe xerosis of the lower limbs, corresponding to grades 2 or 3 on the Overall Dry Skin Score (ODS) scale, confirmed by clinical evaluation.
- Participants presenting a stratum corneum hydration index between 35 and 55 arbitrary units (AU), as measured by corneometry on the forearm during the eligibility assessment.
- Participants considered healthy by the investigator, with no medical conditions or use of medications that could pose an undue risk or interfere with the study results.
- Willingness to comply with all study procedures and attend the study site on the scheduled dates and times for assessments.
Key exclusion criteria (14 listed)
- Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study, when applicable.
- Use of anti-inflammatory, immunosuppressive, antihistamine, or any other medication that, in the investigator's opinion, may interfere with skin condition assessments or study outcomes.
- Presence of skin marks in the test area that may interfere with clinical or instrumental evaluations of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
- Presence of active atopic dermatitis, eczema, or other dermatoses that may interfere with evaluation of the test area.
- Active localized or generalized skin diseases and/or lesions in the assessment area that, in the investigator's opinion, may compromise participation in the study.
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 creamA topical moisturizing product intended for the management of xerosis. The product will be applied twice daily to the lower limbs for 28 consecutive days. Its dermatological acceptability, effects on skin hydration, and effects on skin barrier recovery and strengthening will be evaluated through clinical, subjective, and instrumental assessments, including Corneometer® and Tewameter® measurements. | Other | Investigational Product Group |
Primary outcome
Dermatological Acceptability Assessed by Clinical Dermatological Evaluation
Time frame: Baseline and Day 28
Dermatological acceptability of the investigational product under real-world conditions of use, including the assessment of signs of skin irritation and participant-reported discomfort sensations. Evaluations will be performed by a dermatologist throughout the study period.
6 secondary outcomes
Skin Hydration Assessed by Corneometer®
Time frame: Immediately after application, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 12 hours, 24 hours, and 48 hours after a single application.
Skin Barrier Recovery Assessed by Tewameter® Following Tape Stripping
Time frame: Immediately after application, 1 hour, 2 hours, and 4 hours after a single application.
Perceived Product Performance Assessed by a Perceived Efficacy Questionnaire Following Tape Stripping
Time frame: Immediately after application, 1 hour, and 2 hours after a single application.
Skin Barrier Strengthening Assessed by Tewameter®
Time frame: Day 7 and Day 28
Skin Hydration Assessed by Corneometer®
Time frame: Day 7 and Day 28
Perceived Product Performance Assessed by a Perceived Efficacy Questionnaire
Time frame: Day 7 and 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 2 Nov 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.
Related trials for Xerosis
Active, not recruiting
Xerosis and Use of Topical Moisturizer
Xerosis Due to Atopic Dermatitis
RecruitingPhase 2
Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors
Acneiform Eruption Due to Chemical, Xerosis Cutis
Recruiting
Novel Skin Barrier Product Versus Petrolatum for Skin Barrier Dysfunction
Psoriasis, Atopic Dermatitis
Recruiting
Study on the Effectiveness of an Emollient Cream Containing Pre and Postbiotic and Niacinamide 4% in the Treatment of Skin Xerosis and Itching in Oncological Patients Treated with Anti-EGFR
Xerosis Cutis
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 moisturizing cream in people with Xerosis and Dry 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 14 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 2 Nov 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?
Dermatological Acceptability 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 2 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.