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Not yet recruitingNCT07918560Updated Nov 5, 2026

Cosmetic Efficacy Evaluation of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis

An interventional study of Investigational cream in Atopic Dermatitis and Psoriasis, sponsored by Brainfarma Industria Química e Farmacêutica S/A. Not yet recruiting at 1 site in Brazil. Open to participants aged 3 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Brainfarma Industria Química e Farmacêutica S/A (part of Hypera Pharma) · Not applicable, Interventional, and Treatment

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Non-randomized
Ages
3 Years to 65 Years
Sex
All
01

Study 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? 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.

02

Conditions studied

  • Atopic Dermatitis
  • Psoriasis
03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's planned enrollment of 42 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Brainfarma Industria Química e Farmacêutica S/A is the lead sponsor of 15 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 , 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.

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding participants, or those at risk of pregnancy, when applicable.
  • Use of systemic agents, systemic anti-inflammatory medications, or antihistamines within 3 weeks prior to screening.
  • Use of topical 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.
  • Immunosuppression due to medication use or active disease.
  • Uncontrolled endocrine disorders.
  • history or current evidence of alcohol or drug abuse.
  • Known or suspected intolerance to products of the same category as the 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Atopic dermatitis group

    Participants with atopic dermatitis will apply the investigational cream to the affected areas twice daily for 45 days.

    Other: Investigational cream

  • Experimental
    Psoriasis group

    Participants with psoriasis will apply the investigational cream to the affected skin areas on the face and/or body twice daily for 45 days.

    Other: Investigational cream

Interventions

  • OtherInvestigational cream

    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.

    Also known as: Hydraporin AI Creme

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 30 and Day 45

Secondary outcomes

  1. 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.

    Time frame: Day 30 and Day 45

  2. 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.

    Time frame: Day 30 and Day 45

  3. 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.

    Time frame: Day 30 and Day 45

  4. 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.

    Time frame: Day 30 and Day 45

  5. 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.

    Time frame: Day 30 and Day 45

  6. 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.

    Time frame: Day 30 and Day 45

  7. 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.

    Time frame: Baseline through Day 45

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.

Of 69 industry-sponsored interventional studies with no phase under Dermatitis, Atopic, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 24. This study's planned 4 months is below that.

Counting every sponsor, half of 182 studies reached it within 15 months; a quarter within 6 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 30, 2026
First posted
Nov 5, 2026
StartEst.
Nov 6, 2026
Primary completionEst.
Mar 6, 2027
CompletionEst.
Mar 6, 2027
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07918560
Responsible party
Sponsor
First posted
Nov 5, 2026
Start date
Nov 6, 2026 (estimated)
Primary completion
Mar 6, 2027 (estimated)
Completion
Mar 6, 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Layane Melody Da Silva Reis Cavalcante
Contact
layane.reis@brainfarma.ind.br
+55 (11) 4507-2183

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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