Atopic DermatitisBuPADNCT07016087
Therapeutic Efficacy of Cutaneous Application of Postbiotic N-(1-carbamoyl-2-phenyl-ethyl) Butyramide (FBA) in Pediatric Subjects Affected by Atopic Dermatitis
A study testing Cosmetic formulation experimental and Cosmetic formulation usual in people with Atopic Dermatitis, run by Federico II University at 1 site in Italy.
Trial summary
Atopic dermatitis (AD) is a chronic, multifactorial inflammatory skin disease characterized by eczematous skin and pruritus and it's due to an alteration of the skin barrier and of the intestinal and skin microbiome (SM), which normally contributes to maintaining skin integrity and modulating host inflammatory… Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Cosmetic formulation experimental and Cosmetic formulation usual
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2024to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both sexes;
- Age: 6-36 months
- Caucasian ethnicity
- Diagnosis of atopic dermatitis
- Written informed consent of parents/legal guardians
Who cannot join
- Age <6 months and >36 months
- non-Caucasian ethnicity
- skin infections
- ichthyosis
- food allergies
- chronic systemic diseases
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- congenital heart defects
- tuberculosis
- autoimmune disorders
- immunodeficiency
- inflammatory bowel disease
- celiac disease
- cystic fibrosis
- metabolic disorders
- neoplasms
- chronic pulmonary disorders
- gastrointestinal tract malformations
- respiratory tract malformations
- intake of systemic prebiotics/probiotics/synbiotics/immunomodulators 4 weeks prior to enrollment
- treatment with topical immunomodulators (Tacrolimus or Pimecrolimus) within 3 months prior to enrollment
- use of topical or systemic corticosteroids or calcineurin antagonists or phototherapy within the previous 4 weeks
- investigator uncertainty about the subject's willingness or ability to comply with protocol requirements
- participation in any other study involving investigational or marketed products concurrently or within two weeks prior to study entry hypersensitivity to any component of the investigational product
- absence of written informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Traslational Medical Science - University of Naples Federico II
Naples, Naples, 80131
About this study
Official title: Therapeutic Efficacy of Cutaneous Application of Postbiotic N-(1-carbamoyl-2-phenyl-ethyl) Butyramide (FBA) in Pediatric Subjects Affected by Atopic Dermatitis - BuPAD Trial (Butyrate for Pediatric Atopic Dermatitis)
Atopic dermatitis (AD) is a chronic, multifactorial inflammatory skin disease characterized by eczematous skin and pruritus and it's due to an alteration of the skin barrier and of the intestinal and skin microbiome (SM), which normally contributes to maintaining skin integrity and modulating host inflammatory responses. This alteration leads to a lower production of butyrate, a short-chain fatty acid capable of reducing skin permeability by improving barrier integrity, performing a trophic effect on the skin and suppressing local inflammatory responses. Furthermore, a reduction of butyrate in patients with AD has also been demonstrated at the intestinal level.
Conventional therapy for AD consists of eliminating exacerbating factors, applying emollients and in exacerbations, or in moderate/severe forms, applying topical steroids or topical calcineurin inhibitors. The possibility of using emollients containing substances physiologically present in the skin, such as butyrate, could represent a safe treatment strategy, capable of reducing exacerbations and therefore the evolution towards moderate-severe forms of AD.
On the basis of these premises, the BuPad study aims to evaluate the therapeutic efficacy of the cutaneous application of a butyrate releaser, the postbiotic N-(1-carbamoyl-2-phenyl-ethyl) butyramide (FBA) in a cosmetic formulation, in children affected by AD.
- Conditions
- Atopic Dermatitis
- Being tested
- Cosmetic formulation experimental, Cosmetic formulation usual
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic formulation experimentalOther
Cosmetic formulation containing emollients and a butyrate releaser: the postbiotic N-(1-carbamoyl-2-phenyl-ethyl) butyramide (FBA)
Cosmetic formulation usualOther
Cosmetic formulation containing emollients
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | AD affected patients treated with butyrate-free emollients Receives: Other: Cosmetic formulation usual |
| Group B | Experimental | AD affected patients treated with emollients added with butyrate releaser Receives: Other: Cosmetic formulation experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of topical therapy with a butyrate releaser in children with AD
Evaluation of the efficacy of topical therapy with a butyrate releaser in children with AD evaluated as the rate of subjects achieving the the minimum clinically important difference (MCID) [i.e., reduction of ≥8.7 points of the Scoring Atopic Dermatitis (SCORAD)] index after 12 weeks of treatment
Measured: At 12 weeks
Secondary outcomes (6)
Changes in the SCORAD index
Mean changes in the SCORAD index comparing the baseline value (T0) and the values after 4 weeks (T4) and 8 weeks (T8) of treatment and 4 weeks after the end of treatment (T16)
Measured: At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks
Changes in Transepidermal Water Loss (TEWL)
Mean changes in Transepidermal Water Loss (TEWL) comparing the baseline value (T0) and the values after 4 weeks (T4), 8 weeks (T8) and 12 weeks of treatment (T12) and 4 weeks after the end of treatment (T16)
Measured: At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks
Assessment of skin microbiota
Assessment of the skin microbiota composition at baseline (T0) and at the end of treatment (T12)
Measured: At baseline, at 12 weeks
Number of skin infections during the study period
Number of skin infections during the study period (last follow up after 16 weeks from the start of treatment)
Measured: At 12 weeks, at 16 weeks
Days without use of rescue medications (topical steroid use)
Assessment of days without use of cortisone at T12 and at T16
Measured: At 12 weeks, at 16 weeks
Infant Dermatitis Quality of Life Questionnaire (IDQOL)
Mean changes in the Infant Dermatitis Quality of Life Questionnaire (IDQOL) at T0, T4, T8, T12, T16
Measured: At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start10 Oct 2024
- Primary completion10 Jan 2026
- Study completion10 Feb 2026
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.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016087
- Sponsor's protocol ID
- 102/24
- Acronym
- BuPAD
- Status last verified
- Apr 2026
- First submitted
- 21 May 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy of Cutaneous Application of Postbiotic N-(1-carbamoyl-2-phenyl-ethyl) Butyramide (FBA) in Pediatric Subjects Affected by Atopic Dermatitis - BuPAD Trial (Butyrate for Pediatric Atopic Dermatitis)
- ClinicalTrials.gov ID
- NCT07016087
- Acronym / sponsor ID
- BuPAD / 102/24
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 11 Jun 2025 (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.
Atopic dermatitis (AD) is a chronic, multifactorial inflammatory skin disease characterized by eczematous skin and pruritus and it's due to an alteration of the skin barrier and of the intestinal and skin microbiome (SM), which normally contributes to maintaining skin integrity and modulating host inflammatory responses. This alteration leads to a lower production of butyrate, a short-chain fatty acid capable of reducing skin permeability by improving barrier integrity, performing a trophic effect on the skin and suppressing local inflammatory responses. Furthermore, a reduction of butyrate in patients with AD has also been demonstrated at the intestinal level.
Conventional therapy for AD consists of eliminating exacerbating factors, applying emollients and in exacerbations, or in moderate/severe forms, applying topical steroids or topical calcineurin inhibitors. The possibility of using emollients containing substances physiologically present in the skin, such as butyrate, could represent a safe treatment strategy, capable of reducing exacerbations and therefore the evolution towards moderate-severe forms of AD.
On the basis of these premises, the BuPad study aims to evaluate the therapeutic efficacy of the cutaneous application of a butyrate releaser, the postbiotic N-(1-carbamoyl-2-phenyl-ethyl) butyramide (FBA) in a cosmetic formulation, in children affected by AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Other: Cosmetic formulation usualAD affected patients treated with butyrate-free emollients |
| Group B | Experimental | Other: Cosmetic formulation experimentalAD affected patients treated with emollients added with butyrate releaser |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Both sexes;
- Age: 6-36 months
- Caucasian ethnicity
- Diagnosis of atopic dermatitis
- Written informed consent of parents/legal guardians
Key exclusion criteria (24 listed)
- Age <6 months and >36 months
- non-Caucasian ethnicity
- skin infections
- ichthyosis
- food allergies
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 |
|---|---|---|
| Cosmetic formulation experimentalCosmetic formulation containing emollients and a butyrate releaser: the postbiotic N-(1-carbamoyl-2-phenyl-ethyl) butyramide (FBA) | Other | Group B |
| Cosmetic formulation usualCosmetic formulation containing emollients | Other | Group A |
Primary outcome
Evaluation of the efficacy of topical therapy with a butyrate releaser in children with AD
Time frame: At 12 weeks
Evaluation of the efficacy of topical therapy with a butyrate releaser in children with AD evaluated as the rate of subjects achieving the the minimum clinically important difference (MCID) [i.e., reduction of ≥8.7 points of the Scoring Atopic Dermatitis (SCORAD)] index after 12 weeks of treatment
6 secondary outcomes
Changes in the SCORAD index
Time frame: At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks
Changes in Transepidermal Water Loss (TEWL)
Time frame: At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks
Assessment of skin microbiota
Time frame: At baseline, at 12 weeks
Number of skin infections during the study period
Time frame: At 12 weeks, at 16 weeks
Days without use of rescue medications (topical steroid use)
Time frame: At 12 weeks, at 16 weeks
Infant Dermatitis Quality of Life Questionnaire (IDQOL)
Time frame: At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cosmetic formulation experimental and Cosmetic formulation usual in people with Atopic Dermatitis, run by Federico II University at 1 site in Italy.
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 24 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: finished, as of the sponsor's last update on 13 Apr 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 Italy. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the efficacy of topical therapy with a butyrate releaser in children with AD (time frame: At 12 weeks). 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 13 Apr 2026.