InflammationPhase 4BIANCT06750653
Skin Barrier Function and Inflammation in Aging: The BIA Study
A Phase 4 study testing CeraVe Moisturizing Cream and Vaseline in people with Inflammation and Skin Inflammation, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a randomized, investigator-blinded, self-controlled pilot study of the physiologic response to topical moisturizers among older adults with dry skin. The overarching hypothesis is that skin barrier decline is an important source of chronic inflammation, and that skin barrier restoration with moisturizers can… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Skin Inflammation, Aging
- What is being tested?
- CeraVe Moisturizing Cream and Vaseline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2025to 2 Apr 2026
- Phase
- Phase 4
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male or female ≥ 70 years of age at the baseline visit.
- Diagnosis of xerosis cutis based on an Overall Dry skin (ODS) score of => 1 for any body site where patients will be asked to apply moisturizer (i.e. arms, legs, buttocks, front of trunk).
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative
- Ability for subject to comply with the requirements of the study.
Who cannot join
- History of inflammatory skin disease (e.g. psoriasis, atopic dermatitis, or bullous pemphigoid) that has been active in the past 10 years.
- History of contact dermatitis to moisturizers.
- History of chronic inflammatory conditions (such as cancer, arthritis, inflammatory bowel disease, or coronary artery disease). Participants with a history of localized skin cancer will not be excluded.
- Current infection.
- Open skin wounds.
- Physical limitations or lack of a caregiver preventing application of a moisturizer to skin on the trunk and extremities.
Show all 12Show fewer
- Current use of topical medications, oral systemic immunomodulatory treatments, or anti-microbial treatments.
- Diagnosis of primary or acquired immunodeficiency.
- Use of skin moisturizer less than 1 week prior to enrollment visit, with the exception that participants may use non-study moisturizer/sunscreen on face, if used consistently throughout study period.
- Inability to give informed consent.
- Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.
- If the participant does not meet all the above criteria, he/she will not be eligible for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, investigator-blinded, self-controlled pilot study of the physiologic response to topical moisturizers among older adults with dry skin. The overarching hypothesis is that skin barrier decline is an important source of chronic inflammation, and that skin barrier restoration with moisturizers can reduce serum biomarkers of inflammation. The primary objective is to determine the feasibility for a larger trial, and the secondary objectives are to determine the extent to which measures of serum inflammation, skin barrier function, and the skin microbiome change in response to moisturizers. Participants will be asked to apply one of two topical moisturizers that are widely available over the counter in the US (Vaseline® 100% pure petroleum jelly or CeraVe® moisturizing cream) once daily for 4 weeks to the front of the torso, buttocks, arms, and legs. Subjects will act as their own control (i.e. they will be asked to apply the study moisturizer they are randomized to for one intervention period (4 weeks) and not to apply topical moisturizers for the other 4- week intervention period). Participants will be randomized in a 1:1:1:1 ratio to one of 4 treatment groups: i. no intervention then CeraVe; ii. CeraVe then no intervention; iii. no intervention then Vaseline; iv. Vaseline then no intervention. At each visit (baseline, week 4, and week 8), participants will undergo skin barrier testing, skin microbiome sampling, and phlebotomy to measure serum inflammatory markers.
Read the detailed description
In older adults, inflammation is associated with geriatric conditions, including multimorbidity and frailty, that result in premature death. This phenomenon has been termed 'inflammaging,' and multiple potential mechanisms have been identified, including chronic infections, visceral obesity, increased gut permeability, and cellular senescence, among others.1,2 Limited data suggest that age-associated barrier decline in the skin may also play an important role. Beginning at about age 50, skin barrier decline is caused by decreased Na+/H+ antiporter activity and impaired stratum corneum acidification.3 Persons >70 years of age also suffer from additional defects in cutaneous lipid production.4 The result is reduced resilience to minor injury and epidermal cytokine generation, which may have significant systemic effects, given that the skin is the body's largest organ.5 Additionally, changes in the skin barrier may result in dysbiosis and increased exposure to microbial products, as has been seen in age-associated gut barrier decline.6 Skin barrier decline has been directly correlated with levels of keratinocyte-derived inflammatory markers in aged mice.7 Furthermore, there is experimental evidence that application of moisturizers to aged skin may improve skin barrier function and reduce inflammation. In aged mice, application of petrolatum twice daily for 10 days significantly reduced cutaneous and serum inflammatory cytokines including TNFalpha, IL-1alpha, IL-1beta, and IL-6 after minor injury.7 The investigators propose a randomized, investigator-blinded, self-controlled pilot study of the physiologic response to topical moisturizers among older adults with dry skin. The overarching hypothesis is that skin barrier restoration with moisturizers can reduce serum biomarkers of inflammation. The primary objective is to determine the feasibility for a larger trial, and the secondary objectives are to determine the extent to which measures of serum inflammation, skin barrier function, and the skin microbiome change in response to moisturizers. Participants will be asked to apply one of two topical moisturizers that are widely available over the counter in the US (Vaseline® 100% pure petroleum jelly or CeraVe® moisturizing cream) once daily for 4 weeks to the front of the torso, buttocks, arms, and legs. Subjects will act as their own control (i.e. they will be asked to apply the study moisturizer they are randomized to for one intervention period (4 weeks) and not to apply topical moisturizers for the other 4- week intervention period). Participants will be randomized in a 1:1:1:1 ratio to one of 4 treatment groups: placebo i. no intervention then CeraVe; ii. CeraVe then no intervention; iii. no intervention then Vaseline; iv. Vaseline then no intervention. At each visit (baseline, week 4, and week 8), participants will undergo skin barrier testing, skin microbiome sampling, and phlebotomy to measure serum inflammatory markers.
- Conditions
- Inflammation, Skin Inflammation, Aging
- Being tested
- CeraVe Moisturizing Cream, Vaseline
- Keywords
- CeraVe, Vaseline, Aging, Inflammation, Skin, Older Adults
- Medical subject headings
- Inflammation, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeraVe Moisturizing CreamOther
CeraVe is a formulation of Purified Water, Glycerin, Cetareth-20 and Cetearyl Alcohol, Caprylic/Capric Triglyceride, Behentrimonium Methosulfate and Cetearyl Alcohol, Cetyl Alcohol, Petrolatum, Dimethicone, Hyaluronic Acid, Ceramide 1, Ceramide 3, Ceramide 6-II, Cholesterol, Phytosphingosine, Potassium Phosphate, Dipotassium phosphate, Phenoxyethanol, Methylparaben, Propylparaben, Disodium EDTA, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, manufactured by L'Oréal, for topical skin use.
VaselineDrug
Vaseline is a formulation of active ingredient white petrolatum, USP (100%), manufactured by Unilever, for topical skin use.
| Study group | Role | What they receive |
|---|---|---|
| CeraVe First | Active comparator | CeraVe for 4 weeks; then no moisturizer for 4 weeks. CeraVe Moisturizing Cream containing ceramides and hyaluronic acid manufactured by L'Oréal, for topical skin use. Receives: Other: CeraVe Moisturizing Cream |
| CeraVe Second | Active comparator | No moisturizer for 4 weeks, then CeraVe for the second 4-week study period. CeraVe Moisturizing Cream containing ceramides and hyaluronic acid manufactured by L'Oréal, for topical skin use Receives: Other: CeraVe Moisturizing Cream |
| Vaseline First | Active comparator | Vaseline for 4 weeks then no moisturizer for 4 weeks. Vaseline white petrolatum, manufactured by Unilever, for topical skin use. Receives: Drug: Vaseline |
| Vaseline Second | Active comparator | No moisturizer for 4 weeks; then Vaseline for 4 weeks. Vaseline white petrolatum, manufactured by Unilever, for topical skin use. Receives: Drug: Vaseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate feasibility
To demonstrate the feasibility of a moisturizer-based skin barrier enhancement randomized controlled trial using these measures:
Enrollment Rate: Number of participants enrolled in the study within a specified time frame
Retention Rate: Percentage of participants who complete the study without dropping out, assessed at the end of the trial.
Adherence to Protocol: Percentage of participants who adhere to the treatment regimen as outlined, calculated based on participant self-reports or product usage logs.
Data Collection Completeness: Percentage of complete data sets collected for the primary outcome measure at baseline and follow-up.
Measured: 8 weeks
Secondary outcomes (6)
Change in composite inflammation score
Mean of the individual z-scores for serum inflammatory markers. Mean of the Individual Z-Scores for Serum Inflammatory Markers" assesses the standardized values (z-scores) of serum inflammatory markers in a population.
The normal range for z-scores is typically considered to be between:
-2 and +2: This range typically encompasses about 95% of the data in a normally distributed population.
Outcome Interpretation: Higher z-scores indicate worse outcomes, as they suggest higher levels of inflammatory markers, which are typically associated with inflammation and various health issues.
Measured: 4 weeks
Change in skin barrier function
Transepidermal water loss.
Measured: 4 weeks
Change in skin barrier function
Changes in skin hydration will be measured and recorded using a Tewameter which quantifies the amount of water that evaporates from the skin's surface. Low TEWL values suggest better skin hydration.
Measured: 4 weeks
Change in skin barrier function
pH.
Measured: 4 weeks
Change in skin barrier function
Skin Electrical Impedance Spectroscopy Device: A specialized device designed for skin analysis that delivers a small-range alternating current to the skin surface and measures the voltage response to determine impedance.
Low Impedance Values: Generally indicate better skin hydration, as water facilitates increased conductivity.
High Impedance Values: Suggest lower hydration levels or impaired skin barrier function, as drier skin has reduced conductivity.
Measured: 4 weeks
Measures of skin microbial composition diversity
Differences in overall microbiome composition after moisturizer application
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start6 Feb 2025
- Primary completion2 Apr 2026
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will act as their own control - they will be asked to apply the study moisturizer they are randomized to for one intervention period (4 weeks) and not to apply topical moisturizers for the other 4- week intervention period).
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Katrina Abuabara, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750653
- Sponsor's protocol ID
- 21-34535
- Other IDs
- R21AR082620
- Acronym
- BIA
- Status last verified
- Jul 2026
- First submitted
- 17 Dec 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will provide individual participant level data (IPD) in a de-identified format, along with a data dictionary, statistical analysis plan, analytic code, and the final protocol. This data will be available through the Vivli platform, a non-profit organization dedicated to clinical research data sharing. Data access will be granted as soon as possible or at the time of publication and will be preserved for a minimum of five years post-funding. All shared data will be de-identified using the safe harbor method, following HIPAA privacy regulations. To access the IPD, users must complete the Vivli data request form and sign the Data Use Agreement, which restricts data use and requires data security. Users must submit a valid scientific question and a statistical analysis plan. Approved requests will receive access to the data at no cost for a designated period, with Vivli ensuring storage and access for as long as the data holds scientific value.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Barrier Function and Inflammation in Aging: The BIA Study
- ClinicalTrials.gov ID
- NCT06750653
- Acronym / sponsor ID
- BIA / 21-34535
- Conditions
- Inflammation, Skin Inflammation, Aging
- Keywords
- CeraVe, Vaseline, Aging, Inflammation, Skin, Older Adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 27 Dec 2024 (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 randomized, investigator-blinded, self-controlled pilot study of the physiologic response to topical moisturizers among older adults with dry skin. The overarching hypothesis is that skin barrier decline is an important source of chronic inflammation, and that skin barrier restoration with moisturizers can reduce serum biomarkers of inflammation. The primary objective is to determine the feasibility for a larger trial, and the secondary objectives are to determine the extent to which measures of serum inflammation, skin barrier function, and the skin microbiome change in response to moisturizers. Participants will be asked to apply one of two topical moisturizers that are widely available over the counter in the US (Vaseline® 100% pure petroleum jelly or CeraVe® moisturizing cream) once daily for 4 weeks to the front of the torso, buttocks, arms, and legs. Subjects will act as their own control (i.e. they will be asked to apply the study moisturizer they are randomized to for one intervention period (4 weeks) and not to apply topical moisturizers for the other 4- week intervention period). Participants will be randomized in a 1:1:1:1 ratio to one of 4 treatment groups: i. no intervention then CeraVe; ii. CeraVe then no intervention; iii. no intervention then Vaseline; iv. Vaseline then no intervention. At each visit (baseline, week 4, and week 8), participants will undergo skin barrier testing, skin microbiome sampling, and phlebotomy to measure serum inflammatory markers.
Detailed description
In older adults, inflammation is associated with geriatric conditions, including multimorbidity and frailty, that result in premature death. This phenomenon has been termed 'inflammaging,' and multiple potential mechanisms have been identified, including chronic infections, visceral obesity, increased gut permeability, and cellular senescence, among others.1,2 Limited data suggest that age-associated barrier decline in the skin may also play an important role. Beginning at about age 50, skin barrier decline is caused by decreased Na+/H+ antiporter activity and impaired stratum corneum acidification.3 Persons >70 years of age also suffer from additional defects in cutaneous lipid production.4 The result is reduced resilience to minor injury and epidermal cytokine generation, which may have significant systemic effects, given that the skin is the body's largest organ.5 Additionally, changes in the skin barrier may result in dysbiosis and increased exposure to microbial products, as has been seen in age-associated gut barrier decline.6 Skin barrier decline has been directly correlated with levels of keratinocyte-derived inflammatory markers in aged mice.7 Furthermore, there is experimental evidence that application of moisturizers to aged skin may improve skin barrier function and reduce inflammation. In aged mice, application of petrolatum twice daily for 10 days significantly reduced cutaneous and serum inflammatory cytokines including TNFalpha, IL-1alpha, IL-1beta, and IL-6 after minor injury.7 The investigators propose a randomized, investigator-blinded, self-controlled pilot study of the physiologic response to topical moisturizers among older adults with dry skin. The overarching hypothesis is that skin barrier restoration with moisturizers can reduce serum biomarkers of inflammation. The primary objective is to determine the feasibility for a larger trial, and the secondary objectives are to determine the extent to which measures of serum inflammation, skin barrier function, and the skin microbiome change in response to moisturizers. Participants will be asked to apply one of two topical moisturizers that are widely available over the counter in the US (Vaseline® 100% pure petroleum jelly or CeraVe® moisturizing cream) once daily for 4 weeks to the front of the torso, buttocks, arms, and legs. Subjects will act as their own control (i.e. they will be asked to apply the study moisturizer they are randomized to for one intervention period (4 weeks) and not to apply topical moisturizers for the other 4- week intervention period). Participants will be randomized in a 1:1:1:1 ratio to one of 4 treatment groups: placebo i. no intervention then CeraVe; ii. CeraVe then no intervention; iii. no intervention then Vaseline; iv. Vaseline then no intervention. At each visit (baseline, week 4, and week 8), participants will undergo skin barrier testing, skin microbiome sampling, and phlebotomy to measure serum inflammatory markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Subjects will act as their own control - they will be asked to apply the study moisturizer they are randomized to for one intervention period (4 weeks) and not to apply topical moisturizers for the other 4- week intervention period).
| Arm | Type | Receives |
|---|---|---|
| CeraVe First | Active comparator | Other: CeraVe Moisturizing CreamCeraVe for 4 weeks; then no moisturizer for 4 weeks. CeraVe Moisturizing Cream containing ceramides and hyaluronic acid manufactured by L'Oréal, for topical skin use. |
| CeraVe Second | Active comparator | Other: CeraVe Moisturizing CreamNo moisturizer for 4 weeks, then CeraVe for the second 4-week study period. CeraVe Moisturizing Cream containing ceramides and hyaluronic acid manufactured by L'Oréal, for topical skin use |
| Vaseline First | Active comparator | Drug: VaselineVaseline for 4 weeks then no moisturizer for 4 weeks. Vaseline white petrolatum, manufactured by Unilever, for topical skin use. |
| Vaseline Second | Active comparator | Drug: VaselineNo moisturizer for 4 weeks; then Vaseline for 4 weeks. Vaseline white petrolatum, manufactured by Unilever, for topical skin use. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Male or female ≥ 70 years of age at the baseline visit.
- Diagnosis of xerosis cutis based on an Overall Dry skin (ODS) score of => 1 for any body site where patients will be asked to apply moisturizer (i.e. arms, legs, buttocks, front of trunk).
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative
- Ability for subject to comply with the requirements of the study.
Key exclusion criteria (12 listed)
- History of inflammatory skin disease (e.g. psoriasis, atopic dermatitis, or bullous pemphigoid) that has been active in the past 10 years.
- History of contact dermatitis to moisturizers.
- History of chronic inflammatory conditions (such as cancer, arthritis, inflammatory bowel disease, or coronary artery disease). Participants with a history of localized skin cancer will not be excluded.
- Current infection.
- Open skin wounds.
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 |
|---|---|---|
| CeraVe Moisturizing CreamCeraVe is a formulation of Purified Water, Glycerin, Cetareth-20 and Cetearyl Alcohol, Caprylic/Capric Triglyceride, Behentrimonium Methosulfate and Cetearyl Alcohol, Cetyl Alcohol, Petrolatum, Dimethicone, Hyaluronic Acid, Ceramide 1, Ceramide 3, Ceramide 6-II, Cholesterol, Phytosphingosine, Potassium Phosphate, Dipotassium phosphate, Phenoxyethanol, Methylparaben, Propylparaben, Disodium EDTA, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, manufactured by L'Oréal, for topical skin use. | Other | CeraVe First, CeraVe Second |
| VaselineVaseline is a formulation of active ingredient white petrolatum, USP (100%), manufactured by Unilever, for topical skin use. | Drug | Vaseline First, Vaseline Second |
Primary outcome
Demonstrate feasibility
Time frame: 8 weeks
To demonstrate the feasibility of a moisturizer-based skin barrier enhancement randomized controlled trial using these measures: Enrollment Rate: Number of participants enrolled in the study within a specified time frame Retention Rate: Percentage of participants who complete the study without dropping out, assessed at the end of the trial. Adherence to Protocol: Percentage of participants who adhere to the treatment regimen as outlined, calculated based on participant self-reports or product usage logs. Data Collection Completeness: Percentage of complete data sets collected for the primary outcome measure at baseline and follow-up.
6 secondary outcomes
Change in composite inflammation score
Time frame: 4 weeks
Change in skin barrier function
Time frame: 4 weeks
Change in skin barrier function
Time frame: 4 weeks
Change in skin barrier function
Time frame: 4 weeks
Change in skin barrier function
Time frame: 4 weeks
Measures of skin microbial composition diversity
Time frame: 4 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 14 Jul 2026.
- Individual participant dataSharing planned: Yes. The investigators will provide individual participant level data (IPD) in a de-identified format, along with a data dictionary, statistical analysis plan, analytic code, and the final protocol. This data will be available through the Vivli platform, a non-profit organization dedicated to clinical research data sharing. Data access will be granted as soon as possible or at the time of publication and will be preserved for a minimum of five years post-funding. All shared data will be de-identified using the safe harbor method, following HIPAA privacy regulations. To access the IPD, users must complete the Vivli data request form and sign the Data Use Agreement, which restricts data use and requires data security. Users must submit a valid scientific question and a statistical analysis plan. Approved requests will receive access to the data at no cost for a designated period, with Vivli ensuring storage and access for as long as the data holds scientific value.
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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.
Katrina Abuabara, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CeraVe Moisturizing Cream and Vaseline in people with Inflammation and Skin Inflammation, run by University of California, San Francisco at 1 site in United States.
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 12 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 14 Jul 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Demonstrate feasibility (time frame: 8 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 14 Jul 2026.