Cutaneous InflammationEarly Phase 1NCT03728569
Skin Barrier Dysfunction and the Role of Skin Barrier Restoration
A Early Phase 1 study testing Vanicream Moisturizing Skin Cream and Vanicream Cleansing Soap in people with Cutaneous Inflammation, run by University of Michigan at 1 site in United States.
Trial summary
The objective of this exploratory study is to gain an understanding of cutaneous and systemic inflammation and how restoration of the skin barrier through the use of moisturizer may restore the skin barrier function and reduce systemic inflammation in elderly humans compared to the young. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Inflammation
- What is being tested?
- Vanicream Moisturizing Skin Cream and Vanicream Cleansing Soap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2018to 1 Feb 2021
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged group (>70 years old)
- In good general health
- Body mass index (BMI) preferably in the healthy range (approximately 25 kg/m2) and no greater than 30 kg/m2
- Fitzpatrick skin types I-V
- Disrupted skin barrier defined as transepidermal water loss (TEWL) >5 g/m2/h on the upper arms or >3 g/m2/h on the buttocks
- Clinical signs of skin dryness as determined by the investigator.
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- No disease states or physical conditions that would impair evaluation of the biopsy sites
- Signed, written and witnessed informed consent form
- Willing to comply with study procedures
- Young group (18-30 years old)
- Good general health
- BMI preferably in the healthy range (approximately 25 kg/m2) and no greater than 30 kg/m2
- Fitzpatrick skin types I-V
- Disrupted skin barrier defined as transepidermal water loss (TEWL) >5 g/m2/h on the upper arms or >3 g/m2/h on the buttocks
- Clinical signs of skin dryness as determined by the investigator
- No disease states or physical conditions that would impair evaluation of the biopsy sites
- Signed, written and witnessed informed consent form
- Willing to comply with study procedures
Who cannot join
- Pregnant or lactating women or women contemplating pregnancy for the duration of the protocol (determined by self-report; if subjects are unsure of their pregnancy status, they will be excluded).
- Frailty as determined by research study nurse
- History of inflammatory skin conditions such as psoriasis or atopic dermatitis.
- History of uncontrolled inflammatory or autoimmune disease.
- History of keloids or any other condition that would complicate wound healing
- History of allergic reactions to local lidocaine
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- Frequent nonsteroidal anti-inflammatory drug (NSAID) use (not including low dose aspirin) and unwilling/unable to discontinue NSAIDS for 2 weeks prior to enrollment to the end of the study.
- Systemic steroids (excluding inhaled steroids for asthma) and unwilling/unable to discontinue systemic steroids for 3 weeks prior to enrollment to the end of the study.
- Topical corticosteroid use within 2 weeks of enrollment.
- Topical immunomodulation use such as calcineurin inhibitors within 2 weeks of enrollment
- Other anti-inflammatory or immunodulatory medications (immunosuppression)
- Received an experimental drug or used an experimental device 30 days prior to admission to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skin Barrier Dysfunction and the Role of Skin Barrier Restoration on Cutaneous and Systemic Inflammation in the Aged Population
The objective of this exploratory study is to gain an understanding of cutaneous and systemic inflammation and how restoration of the skin barrier through the use of moisturizer may restore the skin barrier function and reduce systemic inflammation in elderly humans compared to the young. The exploratory study will consist of three visits per subject. Subjects will be instructed to apply a moisturizer (Vanicream Moisturizing Skin Cream) over the entire skin surface from the neck down twice daily for up to 30 days.
- Conditions
- Cutaneous Inflammation
- Being tested
- Vanicream Moisturizing Skin Cream, Vanicream Cleansing Soap
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vanicream Moisturizing Skin CreamOther
Vanicream Moisturizing Skin Cream daily application
Vanicream Cleansing SoapOther
Vanicream Cleansing Soap daily use
| Study group | Role | What they receive |
|---|---|---|
| Subjects over the age of 70 yrs receiving Vanicream | Other | Subjects will be instructed to apply a moisturizer over the entire skin surface from the neck down twice daily. Subjects will also be required to use a bar soap (Vanicream Cleansing Bar) once daily and avoid application of other soaps or cleaners to the body for the duration of the study. Receives: Other: Vanicream Moisturizing Skin Cream; Other: Vanicream Cleansing Soap |
| Subjects between 18 and 30 yrs receiving Vanicream | Other | Subjects will be instructed to apply a moisturizer over the entire skin surface from the neck down twice daily. Subjects will also be required to use a bar soap (Vanicream Cleansing Bar) once daily and avoid application of other soaps or cleaners to the body for the duration of the study. Receives: Other: Vanicream Moisturizing Skin Cream; Other: Vanicream Cleansing Soap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin hydration status in aged and young subjects
Trans-epidermal water loss (TEWL) will be performed on the upper arm and buttocks at Visits 1 and 2. This instrument will measure the amount of water that is lost through the skin. The change in skin hydration status in each subject will be assessed and compared between groups.
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start16 May 2018
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Why it stopped: Enrollment and interactions/interventions paused due to COVID-19. Not expected to resume in the future. This is not a suspension of IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Cutaneous InflammationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Both groups, young and old, will receive the same intervention; therefore, single group study model was chosen.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Fisher, University of Michigan
- Investigators
- Gary Fisher, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728569
- Sponsor's protocol ID
- HUM00138533 / Derm 719
- Status last verified
- Apr 2021
- First submitted
- 29 Oct 2018
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghadially R, Brown BE, Sequeira-Martin SM, Feingold KR, Elias PM. The aged epidermal permeability barrier. Structural, functional, and lipid biochemical abnormalities in humans and a senescent murine model. J Clin Invest. 1995 May;95(5):2281-90. doi: 10.1172/JCI117919.
PubMed 7738193White-Chu EF, Reddy M. Dry skin in the elderly: complexities of a common problem. Clin Dermatol. 2011 Jan-Feb;29(1):37-42. doi: 10.1016/j.clindermatol.2010.07.005.
PubMed 21146730Kim HO, Kim HS, Youn JC, Shin EC, Park S. Serum cytokine profiles in healthy young and elderly population assessed using multiplexed bead-based immunoassays. J Transl Med. 2011 Jul 20;9:113. doi: 10.1186/1479-5876-9-113.
PubMed 21774806Mariani E, Cattini L, Neri S, Malavolta M, Mocchegiani E, Ravaglia G, Facchini A. Simultaneous evaluation of circulating chemokine and cytokine profiles in elderly subjects by multiplex technology: relationship with zinc status. Biogerontology. 2006 Oct-Dec;7(5-6):449-59. doi: 10.1007/s10522-006-9060-8.
PubMed 16967203Surmi BK, Hasty AH. Macrophage infiltration into adipose tissue: initiation, propagation and remodeling. Future Lipidol. 2008;3(5):545-556. doi: 10.2217/17460875.3.5.545.
PubMed 18978945Katoh N, Hirano S, Kishimoto S, Yasuno H. Acute cutaneous barrier perturbation induces maturation of Langerhans' cells in hairless mice. Acta Derm Venereol. 1997 Sep;77(5):365-9. doi: 10.2340/0001555577365369.
PubMed 9298129Lin TK, Man MQ, Santiago JL, Park K, Roelandt T, Oda Y, Hupe M, Crumrine D, Lee HJ, Gschwandtner M, Thyssen JP, Trullas C, Tschachler E, Feingold KR, Elias PM. Topical antihistamines display potent anti-inflammatory activity linked in part to enhanced permeability barrier function. J Invest Dermatol. 2013 Feb;133(2):469-78. doi: 10.1038/jid.2012.335. Epub 2012 Sep 27.
PubMed 23014339Nishijima T, Tokura Y, Imokawa G, Seo N, Furukawa F, Takigawa M. Altered permeability and disordered cutaneous immunoregulatory function in mice with acute barrier disruption. J Invest Dermatol. 1997 Aug;109(2):175-82. doi: 10.1111/1523-1747.ep12319282.
PubMed 9242504Onoue A, Kabashima K, Kobayashi M, Mori T, Tokura Y. Induction of eosinophil- and Th2-attracting epidermal chemokines and cutaneous late-phase reaction in tape-stripped skin. Exp Dermatol. 2009 Dec;18(12):1036-43. doi: 10.1111/j.1600-0625.2009.00899.x.
PubMed 19558500Proksch E, Brasch J, Sterry W. Integrity of the permeability barrier regulates epidermal Langerhans cell density. Br J Dermatol. 1996 Apr;134(4):630-8.
PubMed 8733362Tsai JC, Feingold KR, Crumrine D, Wood LC, Grunfeld C, Elias PM. Permeability barrier disruption alters the localization and expression of TNF alpha/protein in the epidermis. Arch Dermatol Res. 1994;286(5):242-8. doi: 10.1007/BF00387595.
PubMed 8060154Wood LC, Stalder AK, Liou A, Campbell IL, Grunfeld C, Elias PM, Feingold KR. Barrier disruption increases gene expression of cytokines and the 55 kD TNF receptor in murine skin. Exp Dermatol. 1997 Apr;6(2):98-104. doi: 10.1111/j.1600-0625.1997.tb00154.x.
PubMed 9209892Hu L, Mauro TM, Dang E, Man G, Zhang J, Lee D, Wang G, Feingold KR, Elias PM, Man MQ. Epidermal Dysfunction Leads to an Age-Associated Increase in Levels of Serum Inflammatory Cytokines. J Invest Dermatol. 2017 Jun;137(6):1277-1285. doi: 10.1016/j.jid.2017.01.007. Epub 2017 Jan 20.
PubMed 28115059Jiang YJ, Lu B, Crumrine D, Man MQ, Elias PM, Feingold KR. IL-1alpha accelerates stratum corneum formation and improves permeability barrier homeostasis during murine fetal development. J Dermatol Sci. 2009 May;54(2):88-98. doi: 10.1016/j.jdermsci.2009.01.001. Epub 2009 Feb 11.
PubMed 19216058Jung YJ, Jung M, Kim M, Hong SP, Choi EH. IL-1alpha stimulation restores epidermal permeability and antimicrobial barriers compromised by topical tacrolimus. J Invest Dermatol. 2011 Mar;131(3):698-705. doi: 10.1038/jid.2010.344. Epub 2010 Nov 25.
PubMed 21107352
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Barrier Dysfunction and the Role of Skin Barrier Restoration on Cutaneous and Systemic Inflammation in the Aged Population
- ClinicalTrials.gov ID
- NCT03728569
- Acronym / sponsor ID
- HUM00138533 / Derm 719
- Conditions
- Cutaneous Inflammation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment and interactions/interventions paused due to COVID-19. Not expected to resume in the future. This is not a suspension of IRB approval
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 16 May 2018 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 2 Nov 2018 (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 objective of this exploratory study is to gain an understanding of cutaneous and systemic inflammation and how restoration of the skin barrier through the use of moisturizer may restore the skin barrier function and reduce systemic inflammation in elderly humans compared to the young. The exploratory study will consist of three visits per subject. Subjects will be instructed to apply a moisturizer (Vanicream Moisturizing Skin Cream) over the entire skin surface from the neck down twice daily for up to 30 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Both groups, young and old, will receive the same intervention; therefore, single group study model was chosen.
| Arm | Type | Receives |
|---|---|---|
| Subjects over the age of 70 yrs receiving Vanicream | Other | Other: Vanicream Moisturizing Skin Cream, Other: Vanicream Cleansing SoapSubjects will be instructed to apply a moisturizer over the entire skin surface from the neck down twice daily. Subjects will also be required to use a bar soap (Vanicream Cleansing Bar) once daily and avoid application of other soaps or cleaners to the body for the duration of the study. |
| Subjects between 18 and 30 yrs receiving Vanicream | Other | Other: Vanicream Moisturizing Skin Cream, Other: Vanicream Cleansing SoapSubjects will be instructed to apply a moisturizer over the entire skin surface from the neck down twice daily. Subjects will also be required to use a bar soap (Vanicream Cleansing Bar) once daily and avoid application of other soaps or cleaners to the body for the duration of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Aged group (>70 years old)
- In good general health
- Body mass index (BMI) preferably in the healthy range (approximately 25 kg/m2) and no greater than 30 kg/m2
- Fitzpatrick skin types I-V
- Disrupted skin barrier defined as transepidermal water loss (TEWL) >5 g/m2/h on the upper arms or >3 g/m2/h on the buttocks
Key exclusion criteria (12 listed)
- Pregnant or lactating women or women contemplating pregnancy for the duration of the protocol (determined by self-report; if subjects are unsure of their pregnancy status, they will be excluded).
- Frailty as determined by research study nurse
- History of inflammatory skin conditions such as psoriasis or atopic dermatitis.
- History of uncontrolled inflammatory or autoimmune disease.
- History of keloids or any other condition that would complicate wound healing
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 |
|---|---|---|
| Vanicream Moisturizing Skin CreamVanicream Moisturizing Skin Cream daily application | Other | Subjects between 18 and 30 yrs receiving Vanicream, Subjects over the age of 70 yrs receiving Vanicream |
| Vanicream Cleansing SoapVanicream Cleansing Soap daily use | Other | Subjects between 18 and 30 yrs receiving Vanicream, Subjects over the age of 70 yrs receiving Vanicream |
Primary outcome
Change in skin hydration status in aged and young subjects
Time frame: up to 30 days
Trans-epidermal water loss (TEWL) will be performed on the upper arm and buttocks at Visits 1 and 2. This instrument will measure the amount of water that is lost through the skin. The change in skin hydration status in each subject will be assessed and compared between groups.
Results and safety
The study was stopped early (reason given: Enrollment and interactions/interventions paused due to COVID-19. Not expected to resume in the future. This is not a suspension of IRB approval). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Background: PubMed 7738193Ghadially R, Brown BE, Sequeira-Martin SM, Feingold KR, Elias PM. The aged epidermal permeability barrier. Structural, functional, and lipid biochemical abnormalities in humans and a senescent murine model. J Clin Invest. 1995 May;95(5):2281-90. doi: 10.1172/JCI117919.
- Background: PubMed 21146730White-Chu EF, Reddy M. Dry skin in the elderly: complexities of a common problem. Clin Dermatol. 2011 Jan-Feb;29(1):37-42. doi: 10.1016/j.clindermatol.2010.07.005.
- Background: PubMed 21774806Kim HO, Kim HS, Youn JC, Shin EC, Park S. Serum cytokine profiles in healthy young and elderly population assessed using multiplexed bead-based immunoassays. J Transl Med. 2011 Jul 20;9:113. doi: 10.1186/1479-5876-9-113.
- Background: PubMed 16967203Mariani E, Cattini L, Neri S, Malavolta M, Mocchegiani E, Ravaglia G, Facchini A. Simultaneous evaluation of circulating chemokine and cytokine profiles in elderly subjects by multiplex technology: relationship with zinc status. Biogerontology. 2006 Oct-Dec;7(5-6):449-59. doi: 10.1007/s10522-006-9060-8.
- Background: PubMed 18978945Surmi BK, Hasty AH. Macrophage infiltration into adipose tissue: initiation, propagation and remodeling. Future Lipidol. 2008;3(5):545-556. doi: 10.2217/17460875.3.5.545.
- Background: PubMed 9298129Katoh N, Hirano S, Kishimoto S, Yasuno H. Acute cutaneous barrier perturbation induces maturation of Langerhans' cells in hairless mice. Acta Derm Venereol. 1997 Sep;77(5):365-9. doi: 10.2340/0001555577365369.
- Background: PubMed 23014339Lin TK, Man MQ, Santiago JL, Park K, Roelandt T, Oda Y, Hupe M, Crumrine D, Lee HJ, Gschwandtner M, Thyssen JP, Trullas C, Tschachler E, Feingold KR, Elias PM. Topical antihistamines display potent anti-inflammatory activity linked in part to enhanced permeability barrier function. J Invest Dermatol. 2013 Feb;133(2):469-78. doi: 10.1038/jid.2012.335. Epub 2012 Sep 27.
- Background: PubMed 9242504Nishijima T, Tokura Y, Imokawa G, Seo N, Furukawa F, Takigawa M. Altered permeability and disordered cutaneous immunoregulatory function in mice with acute barrier disruption. J Invest Dermatol. 1997 Aug;109(2):175-82. doi: 10.1111/1523-1747.ep12319282.
- Background: PubMed 19558500Onoue A, Kabashima K, Kobayashi M, Mori T, Tokura Y. Induction of eosinophil- and Th2-attracting epidermal chemokines and cutaneous late-phase reaction in tape-stripped skin. Exp Dermatol. 2009 Dec;18(12):1036-43. doi: 10.1111/j.1600-0625.2009.00899.x.
- Background: PubMed 8733362Proksch E, Brasch J, Sterry W. Integrity of the permeability barrier regulates epidermal Langerhans cell density. Br J Dermatol. 1996 Apr;134(4):630-8.
- Background: PubMed 8060154Tsai JC, Feingold KR, Crumrine D, Wood LC, Grunfeld C, Elias PM. Permeability barrier disruption alters the localization and expression of TNF alpha/protein in the epidermis. Arch Dermatol Res. 1994;286(5):242-8. doi: 10.1007/BF00387595.
- Background: PubMed 9209892Wood LC, Stalder AK, Liou A, Campbell IL, Grunfeld C, Elias PM, Feingold KR. Barrier disruption increases gene expression of cytokines and the 55 kD TNF receptor in murine skin. Exp Dermatol. 1997 Apr;6(2):98-104. doi: 10.1111/j.1600-0625.1997.tb00154.x.
- 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. This study is not recruiting at the moment.
Gary Fisher, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vanicream Moisturizing Skin Cream and Vanicream Cleansing Soap in people with Cutaneous Inflammation, run by University of Michigan 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 18 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: stopped early, as of the sponsor's last update on 6 May 2021. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Enrollment and interactions/interventions paused due to COVID-19. Not expected to resume in the future. This is not a suspension of IRB approval). Results are not available in the source record.
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?
Change in skin hydration status in aged and young subjects (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03728569, which also lists 21 linked publications.
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 6 May 2021.