Dermatitis, AtopicNCT02028546
The Effect of Bathing and Moisturizers on Skin Hydration in Atopic Dermatitis: an in Vivo Study
A study testing bathing and moisturizer application in people with Dermatitis, Atopic, run by Srinakharinwirot University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine the hydration effect of various regimens of skin bathing and moisturizer application on atopic dermatitis Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- bathing and moisturizer application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2013to Apr 2013
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- male or female;
- Age range 18-45 years;
- Subjects have history and physical findings consistent with mild to moderate AD with SCORAD score ≤ 40;
- Stop using some drugs such as oral corticosteroid for at least 4 weeks, topical corticosteroid and calcineurin inhibitor for at least 2 weeks, food supplement such as evening primrose oil, wheat extract Flax seed oil sunflowerseed oil, borage oil and fish oil for at least 3 months;
- Subjects who have signed the written informed consent.
Who cannot join
- Subjects who have medical histories such as zinc or essential fatty acid deficiency, end stage renal disease, hypothyroidism, human immunodeficiency virus (HIV), malignancies, obstructive biliary disease, diabetes mellitus and in those who have had radiation or other medical histories that may interfere the outcome;
- Subjects who ingest drugs that could interfere with the study results such as diuretics, antiandrogens, lipid reducing agents, isotretinoin cimetidine;
- Subjects cannot enroll until the end of the project;
- Subjects who have allergy to any ingredient in the moisturizer or cleanser that will be used in the protocol;
- Pregnant woman or lactating woman.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Skin Center, Faculty of Medicine, Srinkharinwirot University
Bangkok, Bangkok, 10110
About this study
The purpose of this study is to determine the hydration effect of various regimens of skin bathing and moisturizer application on atopic dermatitis
- Conditions
- Dermatitis, Atopic
- Being tested
- bathing and moisturizer application
- Keywords
- atopic dermatitis, skin cleansing, cleanser, moisturizer, skin hydration
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bathing and moisturizer applicationProcedure or surgery
regimen 1: soaking an arm for 10 minutes, no moisturizer application regimen 2: soaking an arm for 10 minutes,immediate moisturizer application regimen 3: soaking an arm for 10 minutes, delayed moisturizer application for 30 min.
regimen 4: wait for 10 minutes,no soaking, moisturizer application (moisturizer alone) (All regimens were completed in all patients with 2 visits (7 days interval))
| Study group | Role | What they receive |
|---|---|---|
| Water | Experimental | The patients in water group were soaking an arm for 10 minutes with tap water before application of moisturizer. (Excepted the 4th regimen included no bathing, waited for 10 minutes and followed by moisturizer application.) Receives: Procedure: bathing and moisturizer application |
| mild cleanser | Experimental | The patients in mild cleanser group were soaking an arm for 10 minutes with mild cleanser before application of moisturizer. (Excepted the 4th regimen included no bathing, waited for 10 minutes and followed by moisturizer application.) Non soap base cleanser contained Sodium Cocoyl Isethionate was used in this mild cleanser arm. Receives: Procedure: bathing and moisturizer application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin hydration (skin capacitance) by using Corneometer and the trans-epidermal water loss value by using Tewameter of various regimens of bathing and moisturizer application
Measured: The skin hydration (capacitance value) and transepidermal water loss value were assessed at baseline and every 30 minutes for 120 minutes after each regimen.
Secondary outcomes (1)
skin hydration (capacitance value) by using Corneometer and transepidermal water loss value by using Tewameter between immediate and delayed (30 minutes) moisturizer application after bathing.
Measured: The skin hydration (capacitance value) and TEWL value were assessed at baseline and every 30 minutes for 120 minutes after each regimen.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionFeb 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Srinakharinwirot University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arisa Kaewkes, Srinakharinwirot University
- Investigators
- Arisa Kaewkes, MSc dermatology, Principal investigator, Skin center, Faculty of Medicine, Srinakharinwirot University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028546
- Sponsor's protocol ID
- Srinakharinwirot fund
- Status last verified
- Jan 2014
- First submitted
- 19 Dec 2013
- Last updated
- 7 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bathing and Moisturizers on Skin Hydration in Atopic Dermatitis: an in Vivo Study
- ClinicalTrials.gov ID
- NCT02028546
- Acronym / sponsor ID
- Srinakharinwirot fund
- Conditions
- Dermatitis, Atopic
- Keywords
- atopic dermatitis, skin cleansing, cleanser, moisturizer, skin hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Srinakharinwirot UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 Jan 2014 (estimated)
- 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 purpose of this study is to determine the hydration effect of various regimens of skin bathing and moisturizer application on atopic dermatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water | Experimental | Procedure: bathing and moisturizer applicationThe patients in water group were soaking an arm for 10 minutes with tap water before application of moisturizer. (Excepted the 4th regimen included no bathing, waited for 10 minutes and followed by moisturizer application.) |
| mild cleanser | Experimental | Procedure: bathing and moisturizer applicationThe patients in mild cleanser group were soaking an arm for 10 minutes with mild cleanser before application of moisturizer. (Excepted the 4th regimen included no bathing, waited for 10 minutes and followed by moisturizer application.) Non soap base cleanser contained Sodium Cocoyl Isethionate was used in this mild cleanser arm. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- male or female;
- Age range 18-45 years;
- Subjects have history and physical findings consistent with mild to moderate AD with SCORAD score ≤ 40;
- Stop using some drugs such as oral corticosteroid for at least 4 weeks, topical corticosteroid and calcineurin inhibitor for at least 2 weeks, food supplement such as evening primrose oil, wheat extract Flax seed oil sunflowerseed oil, borage oil and fish oil for at least 3 months;
- Subjects who have signed the written informed consent.
Key exclusion criteria (5 listed)
- Subjects who have medical histories such as zinc or essential fatty acid deficiency, end stage renal disease, hypothyroidism, human immunodeficiency virus (HIV), malignancies, obstructive biliary disease, diabetes mellitus and in those who have had radiation or other medical histories that may interfere the outcome;
- Subjects who ingest drugs that could interfere with the study results such as diuretics, antiandrogens, lipid reducing agents, isotretinoin cimetidine;
- Subjects cannot enroll until the end of the project;
- Subjects who have allergy to any ingredient in the moisturizer or cleanser that will be used in the protocol;
- Pregnant woman or lactating woman.
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 |
|---|---|---|
| bathing and moisturizer applicationregimen 1: soaking an arm for 10 minutes, no moisturizer application regimen 2: soaking an arm for 10 minutes,immediate moisturizer application regimen 3: soaking an arm for 10 minutes, delayed moisturizer application for 30 min. regimen 4: wait for 10 minutes,no soaking, moisturizer application (moisturizer alone) (All regimens were completed in all patients with 2 visits (7 days interval)) | Procedure or surgery | Water, mild cleanser |
Primary outcome
Skin hydration (skin capacitance) by using Corneometer and the trans-epidermal water loss value by using Tewameter of various regimens of bathing and moisturizer application
Time frame: The skin hydration (capacitance value) and transepidermal water loss value were assessed at baseline and every 30 minutes for 120 minutes after each regimen.
1 secondary outcome
skin hydration (capacitance value) by using Corneometer and transepidermal water loss value by using Tewameter between immediate and delayed (30 minutes) moisturizer application after bathing.
Time frame: The skin hydration (capacitance value) and TEWL value were assessed at baseline and every 30 minutes for 120 minutes after each regimen.
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 7 Jan 2014.
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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.
Arisa Kaewkes, MSc dermatology principal investigator
Skin center, Faculty of Medicine, Srinakharinwirot University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bathing and moisturizer application in people with Dermatitis, Atopic, run by Srinakharinwirot University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 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 7 Jan 2014. 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 Thailand. 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 hydration (skin capacitance) by using Corneometer and the trans-epidermal water loss value by using Tewameter of various regimens of bathing and moisturizer application (time frame: The skin hydration (capacitance value) and transepidermal water loss value were assessed at baseline and every 30 minutes for 120 minutes after each regimen.). 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 7 Jan 2014.