Atopic DermatitisNCT03188653
Evaluating the Effects of Cleansers on the Skin
A study testing CeraVe® Eczema Soothing Body Wash, Cetaphil® RestoraDerm® Eczema Calming Body Wash and Dove® Sensitive Skin Body Wash in people with Atopic Dermatitis, run by University of Arizona at 1 site in United States.
Trial summary
This will be a single visit study that will take approximately 2 hours. Up to 50 subjects (up to 25 healthy subjects, and up to 25 subjects with AD) from BUMC dermatology clinics will be enrolled in this study and randomized to receive the 7 cleansers on 7 test spots on their upper extremities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- CeraVe® Eczema Soothing Body Wash, Cetaphil® RestoraDerm® Eczema Calming Body Wash and Dove® Sensitive Skin Body Wash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2017to 31 May 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female, at least 18 years of age Subject must be able to comprehend and read the English language. Healthy skin without concurrent atopic dermatitis or diagnosed with atopic dermatitis by a dermatologist
Who cannot join
- Subjects who do not fit the inclusion criteria. Subjects unable to or unwilling to comply with the study procedures Concurrently have other inflammatory skin conditions. Prior known allergy to any components to of the cleansers tested A subject who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures.
- Subject unable to speak or read the English language, since all consents and instructions will be provided in English.
- Those that are prisoners or cognitively impaired
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona - Banner University Medicine Dermatology
Tucson, Arizona, 85718
About this study
This will be a single visit study that will take approximately 2 hours. Up to 50 subjects (up to 25 healthy subjects, and up to 25 subjects with AD) from BUMC dermatology clinics will be enrolled in this study and randomized to receive the 7 cleansers on 7 test spots on their upper extremities. One spot will serve as a control and not receive any cleanser. Each spot will be cleansed with the corresponding cleanser for 15 seconds then rinsed off with tap water. Skin barrier will be measured at baseline, immediately after, 30, 60 and 90 minutes after rinse off.
Read the detailed description
Up to 50 subjects (up to 25 with healthy skin or 25 with atopic dermatitis) meeting the inclusion criteria will be enrolled in this study. A physical exam will be performed to ensure the subjects have healthy skin versus atopic dermatitis. For atopic dermatitis subjects, AD severity will be graded by the EASI score. Site randomization will be performed to determine which cleansers will be used for each of the 8 test sites (one site will be randomized to act as a control and not receive any cleanser). Baseline skin barrier function (TEWL, pH and hydration) will be measured. Then 1ml of each cleansers will be applied to the corresponding test sites, 2ml of tap water will be added, and lathered in a circular motion for 15 seconds. The sites will then be rinsed off with tap water for 15 seconds. Arms will be padded dry. Barrier functions will be measured again immediately after padding dry, and at 30, 60 and 90 minutes after.
- Conditions
- Atopic Dermatitis
- Being tested
- CeraVe® Eczema Soothing Body Wash, Cetaphil® RestoraDerm® Eczema Calming Body Wash, Dove® Sensitive Skin Body Wash, Eucerin® Skin Calming Body Wash, Aveeno® Skin Relief Body Wash
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeraVe® Eczema Soothing Body WashOther
One of the 7 arm locations will be selected to receive CeraVe® Eczema Soothing Body Wash
Cetaphil® RestoraDerm® Eczema Calming Body WashOther
One of the 7 arm locations will be selected to receive Cetaphil® RestoraDerm® Eczema Calming Body Wash
Dove® Sensitive Skin Body WashOther
One of the 7 arm locations will be selected to receive Dove® Sensitive Skin Body Wash
Eucerin® Skin Calming Body WashOther
One of the 7 arm locations will be selected to receive Eucerin® Skin Calming Body Wash
Aveeno® Skin Relief Body WashOther
One of the 7 arm locations will be selected to receive Aveeno® Skin Relief Body Wash
MooGoo® Milk WashOther
One of the 7 arm locations will be selected to receive MooGoo® Milk Wash
Free & Clear Liquid CleanserOther
One of the 7 arm locations will be selected to receive Free \& Clear Liquid Cleanser
| Study group | Role | What they receive |
|---|---|---|
| CeraVe® Eczema Soothing Body Wash | Active comparator | One of the 7 forearm locations will be selected to receive CeraVe® Eczema Soothing Body Wash one time only. Receives: Other: CeraVe® Eczema Soothing Body Wash |
| Cetaphil® RestoraDerm® Eczema Calming Body Wash | Active comparator | One of the 7 forearm locations will be selected to receive Cetaphil® RestoraDerm® Eczema Calming Body Wash one time only. Receives: Other: Cetaphil® RestoraDerm® Eczema Calming Body Wash |
| Dove® Sensitive Skin Body Wash | Active comparator | One of the 7 forearm locations will be selected to receive Dove® Sensitive Skin Body Wash one time only. Receives: Other: Dove® Sensitive Skin Body Wash |
| Eucerin® Skin Calming Body Wash | Active comparator | One of the 7 forearm locations will be selected to receive Eucerin® Skin Calming Body Wash one time only. Receives: Other: Eucerin® Skin Calming Body Wash |
| Aveeno® Skin Relief Body Wash | Active comparator | One of the 7 forearm locations will be selected to receive Aveeno® Skin Relief Body Wash one time only. Receives: Other: Aveeno® Skin Relief Body Wash |
| MooGoo® Milk Wash | Active comparator | One of the 7 forearm locations will be selected to receive MooGoo® Milk Wash one time only. Receives: Other: MooGoo® Milk Wash |
| Free & Clear Liquid Cleanser | Active comparator | One of the 7 forearm locations will be selected to receive Free \& Clear Liquid Cleanser Receives: Other: Free & Clear Liquid Cleanser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin barrier function
Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring device (VapoMeter).
Measured: 2 hours
Secondary outcomes (2)
Skin barrier function
Stratum corneum hydration status will be measured using hand-held, noninvasive skin barrier measuring device (MoistureMeterSC).
Measured: 2 hours
Skin pH
Skin pH will be measured.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start31 May 2017
- Primary completion31 May 2020
- Study completion31 May 2020
Why it stopped: Investigator left university
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 University of ArizonaThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188653
- Sponsor's protocol ID
- 1705435580
- Status last verified
- Jun 2021
- First submitted
- 30 May 2017
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Cleansers on the Skin
- ClinicalTrials.gov ID
- NCT03188653
- Acronym / sponsor ID
- 1705435580
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left university
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 15 Jun 2017 (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 will be a single visit study that will take approximately 2 hours. Up to 50 subjects (up to 25 healthy subjects, and up to 25 subjects with AD) from BUMC dermatology clinics will be enrolled in this study and randomized to receive the 7 cleansers on 7 test spots on their upper extremities. One spot will serve as a control and not receive any cleanser. Each spot will be cleansed with the corresponding cleanser for 15 seconds then rinsed off with tap water. Skin barrier will be measured at baseline, immediately after, 30, 60 and 90 minutes after rinse off.
Detailed description
Up to 50 subjects (up to 25 with healthy skin or 25 with atopic dermatitis) meeting the inclusion criteria will be enrolled in this study. A physical exam will be performed to ensure the subjects have healthy skin versus atopic dermatitis. For atopic dermatitis subjects, AD severity will be graded by the EASI score. Site randomization will be performed to determine which cleansers will be used for each of the 8 test sites (one site will be randomized to act as a control and not receive any cleanser). Baseline skin barrier function (TEWL, pH and hydration) will be measured. Then 1ml of each cleansers will be applied to the corresponding test sites, 2ml of tap water will be added, and lathered in a circular motion for 15 seconds. The sites will then be rinsed off with tap water for 15 seconds. Arms will be padded dry. Barrier functions will be measured again immediately after padding dry, and at 30, 60 and 90 minutes after.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| CeraVe® Eczema Soothing Body Wash | Active comparator | Other: CeraVe® Eczema Soothing Body WashOne of the 7 forearm locations will be selected to receive CeraVe® Eczema Soothing Body Wash one time only. |
| Cetaphil® RestoraDerm® Eczema Calming Body Wash | Active comparator | Other: Cetaphil® RestoraDerm® Eczema Calming Body WashOne of the 7 forearm locations will be selected to receive Cetaphil® RestoraDerm® Eczema Calming Body Wash one time only. |
| Dove® Sensitive Skin Body Wash | Active comparator | Other: Dove® Sensitive Skin Body WashOne of the 7 forearm locations will be selected to receive Dove® Sensitive Skin Body Wash one time only. |
| Eucerin® Skin Calming Body Wash | Active comparator | Other: Eucerin® Skin Calming Body WashOne of the 7 forearm locations will be selected to receive Eucerin® Skin Calming Body Wash one time only. |
| Aveeno® Skin Relief Body Wash | Active comparator | Other: Aveeno® Skin Relief Body WashOne of the 7 forearm locations will be selected to receive Aveeno® Skin Relief Body Wash one time only. |
| MooGoo® Milk Wash | Active comparator | Other: MooGoo® Milk WashOne of the 7 forearm locations will be selected to receive MooGoo® Milk Wash one time only. |
| Free & Clear Liquid Cleanser | Active comparator | Other: Free & Clear Liquid CleanserOne of the 7 forearm locations will be selected to receive Free \& Clear Liquid Cleanser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female, at least 18 years of age Subject must be able to comprehend and read the English language. Healthy skin without concurrent atopic dermatitis or diagnosed with atopic dermatitis by a dermatologist
Key exclusion criteria (3 listed)
- Subjects who do not fit the inclusion criteria. Subjects unable to or unwilling to comply with the study procedures Concurrently have other inflammatory skin conditions. Prior known allergy to any components to of the cleansers tested A subject who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures.
- Subject unable to speak or read the English language, since all consents and instructions will be provided in English.
- Those that are prisoners or cognitively impaired
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® Eczema Soothing Body WashOne of the 7 arm locations will be selected to receive CeraVe® Eczema Soothing Body Wash | Other | CeraVe® Eczema Soothing Body Wash |
| Cetaphil® RestoraDerm® Eczema Calming Body WashOne of the 7 arm locations will be selected to receive Cetaphil® RestoraDerm® Eczema Calming Body Wash | Other | Cetaphil® RestoraDerm® Eczema Calming Body Wash |
| Dove® Sensitive Skin Body WashOne of the 7 arm locations will be selected to receive Dove® Sensitive Skin Body Wash | Other | Dove® Sensitive Skin Body Wash |
| Eucerin® Skin Calming Body WashOne of the 7 arm locations will be selected to receive Eucerin® Skin Calming Body Wash | Other | Eucerin® Skin Calming Body Wash |
| Aveeno® Skin Relief Body WashOne of the 7 arm locations will be selected to receive Aveeno® Skin Relief Body Wash | Other | Aveeno® Skin Relief Body Wash |
| MooGoo® Milk WashOne of the 7 arm locations will be selected to receive MooGoo® Milk Wash | Other | MooGoo® Milk Wash |
| Free & Clear Liquid CleanserOne of the 7 arm locations will be selected to receive Free \& Clear Liquid Cleanser | Other | Free & Clear Liquid Cleanser |
Primary outcome
Skin barrier function
Time frame: 2 hours
Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring device (VapoMeter).
2 secondary outcomes
Skin barrier function
Time frame: 2 hours
Skin pH
Time frame: 2 hours
Results and safety
The study was stopped early (reason given: Investigator left university). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- 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.
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 CeraVe® Eczema Soothing Body Wash, Cetaphil® RestoraDerm® Eczema Calming Body Wash and Dove® Sensitive Skin Body Wash in people with Atopic Dermatitis, run by University of Arizona 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 1 inclusion and 3 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 4 Jun 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.
Are results available for this study?
The study was stopped early (reason given: Investigator left university). 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?
Skin barrier function (time frame: 2 hours). 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 4 Jun 2021.