Atopic DermatitisNCT07918560
Cosmetic Efficacy Evaluation of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis
A study testing Investigational cream in people with Atopic Dermatitis and Psoriasis, 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 cosmetic efficacy and safety of an investigational cream in participants with atopic dermatitis or psoriasis. The main questions it aims to answer are: Does the investigational cream improve skin condition and participant-reported outcomes after 30 and 45 days of use?… Read more about this study
- Who is it for?
- Ages 3 to 65 years
- Conditions the study is for
- Atopic Dermatitis, Psoriasis
- What is being tested?
- Investigational cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Nov 2026to 6 Mar 2027
- 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 3 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female participants meeting one of the following age criteria:
- Group I (Atopic Dermatitis): 3 to 12 years or 18 to 50 years of age.
- Group II (Psoriasis): 18 to 65 years of age.
- Group I: Clinical diagnosis of atopic dermatitis with active mild eczema at enrollment and an EASI score between 7.1 and 9 points.
- Group II: Clinical diagnosis of psoriasis with active disease at enrollment, classified as mild to moderate according to PASI, with a score between 1 and 15 points.
- Willingness and ability to comply with study procedures and attend all scheduled visits and assessments.
- Participant, parent, or legally authorized representative able to understand, provide informed consent, and sign the Informed Consent Form (ICF).
- For Group I, participants aged 7 years or older who are able to read and write must understand, provide assent, and sign the Assent Form.
Who cannot join
- Pregnant or breastfeeding participants, or those at risk of pregnancy, when applicable.
- Use of systemic immunosuppressive agents, systemic anti-inflammatory medications, or antihistamines within 3 weeks prior to screening.
- Use of topical corticosteroids for the management of atopic dermatitis or psoriasis is permitted and will be documented at enrollment, including active ingredient, concentration, frequency of use, and application site.
- Skin conditions in the assessment area that may interfere with the evaluation of cutaneous reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn, except when associated with atopic dermatitis or psoriasis lesions.
- History of allergy to cosmetic products.
- Presence of concomitant dermatological disorders or active skin lesions in the assessment area that could interfere with interpretation of the study results, except for atopic dermatitis or psoriasis.
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- Immunosuppression due to medication use or active disease.
- Uncontrolled endocrine disorders.
- Clinically relevant history or current evidence of alcohol or drug abuse.
- Known or suspected intolerance to products of the same category as the investigational product.
- Intense sun exposure within 15 days prior to evaluation.
- Cosmetic or dermatological treatments within 4 weeks prior to evaluation.
- Anticipated need to initiate or modify dermatological drug treatments during the study period.
- Any other condition that, in the opinion of the investigator, would make participation in the study inappropriate.
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
Grupo Medcin
Osasco, São Paulo, 06023-070
Layane Melody Da Silva Reis Cavalcante, +55 (11) 4507-2183, layane.reis@brainfarma.ind.br
Sergio Schalka
About this study
Official title: Evaluation of the Cosmetic Efficacy of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis: Clinical, Instrumental, and Subjective Study
The goal of this clinical trial is to evaluate the cosmetic efficacy and safety of an investigational cream in participants with atopic dermatitis or psoriasis. The main questions it aims to answer are:
Does the investigational cream improve skin condition and participant-reported outcomes after 30 and 45 days of use? Does the investigational cream improve clinical signs, skin hydration, skin barrier function, skin pH, and quality of life in participants with atopic dermatitis or psoriasis?
Read more
Participants will:
Apply the investigational cream twice daily for 45 days. Attend study visits at baseline, Day 30, and Day 45. Undergo clinical, instrumental, and subjective assessments. Complete questionnaires regarding quality of life and product perception. Undergo skin hydration, transepidermal water loss, and skin pH evaluations.
- Conditions
- Atopic Dermatitis, Psoriasis
- Being tested
- Investigational cream
- Medical subject headings
- Dermatitis, Atopic, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational creamOther
Also called Hydraporin AI Creme
Investigational cream intended for topical application to improve skin condition in individuals with atopic dermatitis or psoriasis. The cream is applied to affected skin areas twice daily for 45 days.
| Study group | Role | What they receive |
|---|---|---|
| Atopic dermatitis group | Experimental | Participants with atopic dermatitis will apply the investigational cream to the affected areas twice daily for 45 days. Receives: Other: Investigational cream |
| Psoriasis group | Experimental | Participants with psoriasis will apply the investigational cream to the affected skin areas on the face and/or body twice daily for 45 days. Receives: Other: Investigational cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant-perceived efficacy of the investigational cream after 30 and 45 days of use
Assessment of participants' perception of the efficacy of the investigational cream using a participant-reported questionnaire evaluating skin symptoms, with responses rated on a 4-point scale ranging from 0 (not relevant) to 3 (very much), after 30 and 45 days of continuous use.
Measured: Day 30 and Day 45
Secondary outcomes (7)
Eczema Area and Severity Index (EASI) or Psoriasis Area and Severity Index (PASI) score after 30 and 45 days of use
Assessment of clinical disease severity using the Eczema Area and Severity Index (EASI) in participants with atopic dermatitis and the Psoriasis Area and Severity Index (PASI) in participants with psoriasis. For both scales, lower scores indicate less severe disease and higher scores indicate greater disease severity.
Measured: Day 30 and Day 45
Skin hydration measured by Corneometer® after 30 and 45 days of use
Assessment of skin hydration in lesional and non-lesional skin using Corneometer® measurements. Higher values indicate greater skin hydration.
Measured: Day 30 and Day 45
Transepidermal water loss measured by Tewameter®
Assessment of skin barrier integrity in lesional and non-lesional skin using transepidermal water loss measurements obtained with Tewameter®. Lower values indicate better skin barrier function.
Measured: Day 30 and Day 45
Skin pH measured by pHmeter® after 30 and 45 days of useDay 45
Assessment of skin surface pH in lesional and non-lesional skin using pHmeter® measurements.
Measured: Day 30 and Day 45
Dermatology Life Quality Index (DLQI) score after 30 and 45 days of use
Assessment of quality of life using the Dermatology Life Quality Index (DLQI). Total scores range from 0 to 30, with higher scores indicating greater impairment of quality of life.
Measured: Day 30 and Day 45
Clinical improvement of target lesions assessed by standardized photography after 30 and 45 days of use
Assessment of clinical changes in target lesions through standardized photographic documentation.
Measured: Day 30 and Day 45
Use of topical corticosteroid rescue medication during the study period
Assessment of the need for topical corticosteroid rescue medication during treatment with the investigational cream.
Measured: Baseline through Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start6 Nov 2026 (estimated)
- Primary completion6 Mar 2027 (estimated)
- Study completion6 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT07918560
- Sponsor's protocol ID
- 26-0197-07
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cosmetic Efficacy of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis: Clinical, Instrumental, and Subjective Study
- ClinicalTrials.gov ID
- NCT07918560
- Acronym / sponsor ID
- 26-0197-07
- Conditions
- Atopic Dermatitis, Psoriasis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/AIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2026 (estimated)
- Primary completion
- 6 Mar 2027 (estimated)
- Study completion
- 6 Mar 2027 (estimated)
- First posted
- 5 Nov 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 cosmetic efficacy and safety of an investigational cream in participants with atopic dermatitis or psoriasis. The main questions it aims to answer are:
Does the investigational cream improve skin condition and participant-reported outcomes after 30 and 45 days of use? Does the investigational cream improve clinical signs, skin hydration, skin barrier function, skin pH, and quality of life in participants with atopic dermatitis or psoriasis?
Participants will:
Apply the investigational cream twice daily for 45 days. Attend study visits at baseline, Day 30, and Day 45. Undergo clinical, instrumental, and subjective assessments. Complete questionnaires regarding quality of life and product perception. Undergo skin hydration, transepidermal water loss, and skin pH evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atopic dermatitis group | Experimental | Other: Investigational creamParticipants with atopic dermatitis will apply the investigational cream to the affected areas twice daily for 45 days. |
| Psoriasis group | Experimental | Other: Investigational creamParticipants with psoriasis will apply the investigational cream to the affected skin areas on the face and/or body twice daily for 45 days. |
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female participants meeting one of the following age criteria:
- Group I (Atopic Dermatitis): 3 to 12 years or 18 to 50 years of age.
- Group II (Psoriasis): 18 to 65 years of age.
- Group I: Clinical diagnosis of atopic dermatitis with active mild eczema at enrollment and an EASI score between 7.1 and 9 points.
- Group II: Clinical diagnosis of psoriasis with active disease at enrollment, classified as mild to moderate according to PASI, with a score between 1 and 15 points.
Key exclusion criteria (14 listed)
- Pregnant or breastfeeding participants, or those at risk of pregnancy, when applicable.
- Use of systemic immunosuppressive agents, systemic anti-inflammatory medications, or antihistamines within 3 weeks prior to screening.
- Use of topical corticosteroids for the management of atopic dermatitis or psoriasis is permitted and will be documented at enrollment, including active ingredient, concentration, frequency of use, and application site.
- Skin conditions in the assessment area that may interfere with the evaluation of cutaneous reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn, except when associated with atopic dermatitis or psoriasis lesions.
- History of allergy to cosmetic products.
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 |
|---|---|---|
| Investigational creamAlso: Hydraporin AI CremeInvestigational cream intended for topical application to improve skin condition in individuals with atopic dermatitis or psoriasis. The cream is applied to affected skin areas twice daily for 45 days. | Other | Atopic dermatitis group, Psoriasis group |
Primary outcome
Participant-perceived efficacy of the investigational cream after 30 and 45 days of use
Time frame: Day 30 and Day 45
Assessment of participants' perception of the efficacy of the investigational cream using a participant-reported questionnaire evaluating skin symptoms, with responses rated on a 4-point scale ranging from 0 (not relevant) to 3 (very much), after 30 and 45 days of continuous use.
7 secondary outcomes
Eczema Area and Severity Index (EASI) or Psoriasis Area and Severity Index (PASI) score after 30 and 45 days of use
Time frame: Day 30 and Day 45
Skin hydration measured by Corneometer® after 30 and 45 days of use
Time frame: Day 30 and Day 45
Transepidermal water loss measured by Tewameter®
Time frame: Day 30 and Day 45
Skin pH measured by pHmeter® after 30 and 45 days of useDay 45
Time frame: Day 30 and Day 45
Dermatology Life Quality Index (DLQI) score after 30 and 45 days of use
Time frame: Day 30 and Day 45
Clinical improvement of target lesions assessed by standardized photography after 30 and 45 days of use
Time frame: Day 30 and Day 45
Use of topical corticosteroid rescue medication during the study period
Time frame: Baseline through Day 45
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 5 Nov 2026.
- Individual participant dataSharing planned: No
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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 Investigational cream in people with Atopic Dermatitis and Psoriasis, 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 8 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: opening soon, as of the sponsor's last update on 5 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?
Participant-perceived efficacy of the investigational cream after 30 and 45 days of use (time frame: Day 30 and Day 45). 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 5 Nov 2026.