Atopic DermatitisNCT04763512
Clinical Study of Partially Hydrolysed Protein Infant Formula on Trans-epidermal Water Loss (TEWL)
A study testing Intact Cow's Milk Protein Formula and Partially Hydrolysed Whey Formula in people with Atopic Dermatitis and Skin Condition, run by Société des Produits Nestlé (SPN) at 1 site in China.
Trial summary
This is a single-centre, prospective, randomized, open-label, controlled trial of 200 infants 42±7 days of age. Subjects will be randomized to one of two open label feeding intervention group: Intact Cow's Milk Protein Formula Group (CMFG) (n = 100) or Partially Hydrolysed Whey Formula Group (pHFG) (n = 100). Read more about this study
- Who is it for?
- Ages 35 to 49 daysHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Skin Condition
- What is being tested?
- Intact Cow's Milk Protein Formula and Partially Hydrolysed Whey Formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2021to 2 Nov 2024
- 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 35 to 49 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants 42± 7 days of age at enrolment (date of birth = age 0).
- Infants who have been born full-term gestational birth (≥ 37 completed weeks of gestation) and having a birth weight ≥ 2.5 kg and ≤ 4.5 kg.
- Parents /caregivers must agree to follow study procedures and recommended skincare routines, such as avoidance of moisturizers or other skincare products on the primary sites of interest.
- Parent(s) must have already independently elected before enrolment to formula feed and less than 30% of intake will be from breastmilk.
Who cannot join
- Known and diagnosed cow's milk protein allergy/intolerance.
- Infants currently using or have ever used partially hydrolysed protein formulas.
- Infants who have ever used topical corticosteroids, calcineurin inhibitors and/or any other physician-recommended treatments for skin conditions after birth.
- Infants who have been introduced to complementary foods.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tonxin Pediatric Clinic Co. Ltd
Shanghai, Shanghai Municipality
About this study
This is a single-centre, prospective, randomized, open-label, controlled trial of 200 infants 42±7 days of age. Subjects will be randomized to one of two open label feeding intervention group:
- Intact Cow's Milk Protein Formula Group (CMFG) (n = 100) or
- Partially Hydrolysed Whey Formula Group (pHFG) (n = 100).
Read the detailed description
Atopic dermatitis (AD) affects 15 - 30% of children. Approximately 45% of these cases have an onset within the first 6 months of life and 60% develop within the first year (Bieber 2010). Besides environmental factors, the aetiology of AD has been found to be associated with genetic variants involved in skin barrier function defect and inflammation, leading to dry skin with increases in susceptibility to environmental exposures (Bieber 2008).
Partially hydrolysed cow's milk (whey) protein infant formula (pHF) has been shown to be effective in prevention of AD, both among at-risk and healthy infants (Exl, Deland et al. 2000, von Berg, Koletzko et al. 2003, Jingrana and Dunjina 2015). However, to date there are no published pediatric data to document the relationship between partially hydrolysed protein formulas and skin barrier function, specifically evaluating the effect of pHF on Trans-epidermal Water Loss (TEWL) among infants. Therefore, this study aims to evaluate the effect on skin barrier function as measured by TEWL and we hypothesize that infants consuming partially hydrolysed starter formula will have lower TEWL when compared infants consuming intact cow's milk protein starter formula.
- Conditions
- Atopic Dermatitis, Skin Condition
- Being tested
- Intact Cow's Milk Protein Formula, Partially Hydrolysed Whey Formula
- Keywords
- atopic dermatitis development, trans-epidermal water loss, allergy, growth patterns, quality of life, gut comfort, partially hydrolysed whey
- Medical subject headings
- Dermatitis, Atopic, Skin Diseases, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intact Cow's Milk Protein FormulaDietary supplement
Study product will be provided as powder, reconstituted with water by parents/caregivers according to label instructions, and consumed orally. Study participants will continue this feeding regimen for 4 months.
Partially Hydrolysed Whey FormulaDietary supplement
Study product will be provided as powder, reconstituted with water by parents/caregivers according to label instructions, and consumed orally. Study participants will continue this feeding regimen for 16 months.
| Study group | Role | What they receive |
|---|---|---|
| Intact Cow's Milk Protein Formula Group (CMFG) | Experimental | All enrolled subjects will be fed Stage 1 CMF libitum for 4 months. Thereafter, they will discontinue study formula and complete the study. Receives: Dietary Supplement: Intact Cow's Milk Protein Formula |
| Partially Hydrolysed Whey Formula Group (pHFG) | Experimental | All enrolled subjects will be fed Stage 1 pHF libitum for 4 months. Thereafter, they will switch to Stage 2 pHF at age 6 months (Study Month 4) and to Stage 3 pHF at age 12 months (Study Month 9) and continue until age 18 months (Study Month 15). Thereafter, they will discontinue study formula and complete the study. Receives: Dietary Supplement: Partially Hydrolysed Whey Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin barrier function
Change in Trans-epidermal water loss (TEWL)
Measured: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Secondary outcomes (11)
Weight
Weight in grams and corresponding Z-score according to WHO reference standards and/or local standardized growth charts will be calculated.
Measured: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Length
Length in centimeters and corresponding Z-score according to WHO reference standards and/or local standardized growth charts will be calculated.
Measured: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Head Circumference
Head circumference in centimeters and corresponding Z-score according to WHO reference standards and/or local standardized growth charts will be calculated.
Measured: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Infant health-related quality of life
Assessed through a parent-reported, validated questionnaire called Infant Toddler Quality of Life questionnaire 47-item short-form (ITQOL-SF47). For each concept, item responses are scored, summed, and transformed on a scale from 0 (worst health) to 100 (best health).
Measured: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Infant health-related quality of life
Assessed through the Happy Growth Index Questionnaire with each question rated on a Likert scale from strongly disagree to strongly agree.
Measured: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Incidence and severity of Atopic Dermatitis (AD) and other allergic manifestations (CMF group)
Incidence will be gathered from standard Adverse Event (AE) reporting. Atopic Dermatitis (AD) will be diagnose based on the Williams diagnostic criteria of International Study of Asthma and Allergies in Childhood (ISAAC). Severity of AD will be assessed using the SCORing Atopic Dermatitis (SCORAD) index, which consists of the extent and intensity of the disorder and subjective symptoms.
Measured: aseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Infant gut comfort
Using the Infant Gastrointestinal Symptom Questionnaire (IGSQ)-13.
Measured: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Toddler gut comfort
Using the Toddler Gut Comfort Questionnaire.
Measured: Study Month 9 (age 12 months) and Study Month 15 (age 18 months)
Stool consistency
Parents will record for 3 consecutive days after each bowel movement in a 3-Day Stool Diary the stool consistency on a validated 5-point scale from 1-watery to 5-hard.
Measured: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Formula acceptance and satisfaction
Formula intake, acceptability and satisfaction recorded using the Milk Intake and Satisfaction Questionnaire.
Measured: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Safety assessment: Adverse events (AEs)
Using standard adverse events (AEs) reporting for safety assessment.
Measured: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start6 Jun 2021
- Primary completion19 Sep 2023
- Study completion2 Nov 2024
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 Société des Produits Nestlé (SPN)The 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medidata Solutions, SAS Institute, Veeva Systems, Cognizant Technology Solutions AG
- Responsible party
- Sponsor
- Investigators
- Jie Shao, Dr., Principal investigator, Shanghai Tonxin Pediatric Clinic Co. Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763512
- Sponsor's protocol ID
- 20.16.INF
- Status last verified
- Jun 2025
- First submitted
- 19 Nov 2020
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Partially Hydrolysed Protein Infant Formula on Trans-epidermal Water Loss (TEWL)
- ClinicalTrials.gov ID
- NCT04763512
- Acronym / sponsor ID
- 20.16.INF
- Conditions
- Atopic Dermatitis, Skin Condition
- Keywords
- atopic dermatitis development, trans-epidermal water loss, allergy, growth patterns, quality of life, gut comfort, partially hydrolysed whey
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Medidata Solutions, SAS Institute, Veeva Systems, Cognizant Technology Solutions AG
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 2 Nov 2024 (actual)
- First posted
- 21 Feb 2021 (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.
This is a single-centre, prospective, randomized, open-label, controlled trial of 200 infants 42±7 days of age. Subjects will be randomized to one of two open label feeding intervention group:
- Intact Cow's Milk Protein Formula Group (CMFG) (n = 100) or
- Partially Hydrolysed Whey Formula Group (pHFG) (n = 100).
Detailed description
Atopic dermatitis (AD) affects 15 - 30% of children. Approximately 45% of these cases have an onset within the first 6 months of life and 60% develop within the first year (Bieber 2010). Besides environmental factors, the aetiology of AD has been found to be associated with genetic variants involved in skin barrier function defect and inflammation, leading to dry skin with increases in susceptibility to environmental exposures (Bieber 2008).
Partially hydrolysed cow's milk (whey) protein infant formula (pHF) has been shown to be effective in prevention of AD, both among at-risk and healthy infants (Exl, Deland et al. 2000, von Berg, Koletzko et al. 2003, Jingrana and Dunjina 2015). However, to date there are no published pediatric data to document the relationship between partially hydrolysed protein formulas and skin barrier function, specifically evaluating the effect of pHF on Trans-epidermal Water Loss (TEWL) among infants. Therefore, this study aims to evaluate the effect on skin barrier function as measured by TEWL and we hypothesize that infants consuming partially hydrolysed starter formula will have lower TEWL when compared infants consuming intact cow's milk protein starter formula.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intact Cow's Milk Protein Formula Group (CMFG) | Experimental | Dietary Supplement: Intact Cow's Milk Protein FormulaAll enrolled subjects will be fed Stage 1 CMF libitum for 4 months. Thereafter, they will discontinue study formula and complete the study. |
| Partially Hydrolysed Whey Formula Group (pHFG) | Experimental | Dietary Supplement: Partially Hydrolysed Whey FormulaAll enrolled subjects will be fed Stage 1 pHF libitum for 4 months. Thereafter, they will switch to Stage 2 pHF at age 6 months (Study Month 4) and to Stage 3 pHF at age 12 months (Study Month 9) and continue until age 18 months (Study Month 15). Thereafter, they will discontinue study formula and complete the study. |
Who may qualify
- Ages
- 35 to 49 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants 42± 7 days of age at enrolment (date of birth = age 0).
- Infants who have been born full-term gestational birth (≥ 37 completed weeks of gestation) and having a birth weight ≥ 2.5 kg and ≤ 4.5 kg.
- Parents /caregivers must agree to follow study procedures and recommended skincare routines, such as avoidance of moisturizers or other skincare products on the primary sites of interest.
- Parent(s) must have already independently elected before enrolment to formula feed and less than 30% of intake will be from breastmilk.
Key exclusion criteria (4 listed)
- Known and diagnosed cow's milk protein allergy/intolerance.
- Infants currently using or have ever used partially hydrolysed protein formulas.
- Infants who have ever used topical corticosteroids, calcineurin inhibitors and/or any other physician-recommended treatments for skin conditions after birth.
- Infants who have been introduced to complementary foods.
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 |
|---|---|---|
| Intact Cow's Milk Protein FormulaStudy product will be provided as powder, reconstituted with water by parents/caregivers according to label instructions, and consumed orally. Study participants will continue this feeding regimen for 4 months. | Dietary supplement | Intact Cow's Milk Protein Formula Group (CMFG) |
| Partially Hydrolysed Whey FormulaStudy product will be provided as powder, reconstituted with water by parents/caregivers according to label instructions, and consumed orally. Study participants will continue this feeding regimen for 16 months. | Dietary supplement | Partially Hydrolysed Whey Formula Group (pHFG) |
Primary outcome
Skin barrier function
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Change in Trans-epidermal water loss (TEWL)
11 secondary outcomes
Weight
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Length
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Head Circumference
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Infant health-related quality of life
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Infant health-related quality of life
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Incidence and severity of Atopic Dermatitis (AD) and other allergic manifestations (CMF group)
Time frame: aseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Infant gut comfort
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Toddler gut comfort
Time frame: Study Month 9 (age 12 months) and Study Month 15 (age 18 months)
Stool consistency
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)
Formula acceptance and satisfaction
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
Safety assessment: Adverse events (AEs)
Time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months) - in both randomized groups and until Study Month 15 (age 18 months) in pHF group only
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 27 Jun 2025.
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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.
Jie Shao, Dr. principal investigator
Shanghai Tonxin Pediatric Clinic Co. Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intact Cow's Milk Protein Formula and Partially Hydrolysed Whey Formula in people with Atopic Dermatitis and Skin Condition, run by Société des Produits Nestlé (SPN) at 1 site in China.
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 4 inclusion and 4 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 27 Jun 2025. 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 China. 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?
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?
Skin barrier function (time frame: Baseline (age 42 ± 7 days) to Study Month 4 (age 6 months)). 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 27 Jun 2025.