Atopic DermatitisPhase 4NCT01065714
A Study to Investigate the Use of Hydrogel Vehicle in Maintaining the Skin Barrier in Persons With Atopic Dermatitis
A Phase 4 study testing Eucerin Lotion in people with Atopic Dermatitis, run by Derm Research, PLLC at 1 site in United States.
Trial summary
While the repair of the epidermal barrier in atopic dermatitis is of major importance in the treatment of atopic dermatitis, most of the vehicles used may actually cause a worsening of an impaired epidermal barrier. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Eucerin Lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Nov 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Definitive diagnosis of atopic dermatitis as characterized by Hanifin and Rajka criteria:
- 3 out of 4 major characteristics
- At least 3 minor characteristics
- Mild to moderate disease score of 2 or 3 by Investigator Global Assessment
- Minimum 5% Body Surface Area at Baseline
- Uniformly bilateral signs and symptoms of atopic dermatitis
- Able to understand and comply with the requirements of the study and sign Informed Consent/HIPAA forms. Subjects under the legal age of consent must also have written informed consent of the parent or legal guardian.
Who cannot join
- Allergy or sensitivity to any component of the test articles.
- Subjects who have not complied with the proper washout periods for prohibited medications.
- Significant coagulation disorder or any medical condition that, in the opinion of the investigator, contraindicates the subject's participation in the study.
- Recent alcohol or drug abuse is evident.
- History of poor cooperation, non-compliance with medical treatment or unreliability
- Participation in an investigational drug study within 30 days of the Baseline Visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transepidermal Water Loss (TEWL) and Corneometry With Hydrogel Vehicle in the Treatment of Atopic Dermatitis - A Randomized, Investigator-Blind Pilot Study
While the repair of the epidermal barrier in atopic dermatitis is of major importance in the treatment of atopic dermatitis, most of the vehicles used may actually cause a worsening of an impaired epidermal barrier. Hydrogel vehicle is anecdotally known to be moisturizing and hydrating.This study will compare the use of Hydrogel vehicle and Eucerin Lotion in maintaining the epidermal barrier in subjects with atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- Hydrogel vehicle, Eucerin Lotion
- Keywords
- Transepidermal water loss, Epidermal barrier, 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.
Hydrogel vehicleDrug
Each morning and evening, gently wash the target area with warm water and gently pat dry with soft towel. Once dry place a small amount of Hydrogel vehicle onto the tip of your finger. Place a dab of the Hydrogel vehicle on either the left or right side of the body as instructed. (Do not use Hydrogel vehicle and Eucerin lotion on the same side of the body.)
Eucerin LotionDrug
Each morning and evening, gently wash the area with warm water and pat dry with a soft towel. Once dry, place a small amount of Eucerin lotion to the target area on either the left or right side of the body as instructed. (Do not use Eucerin and Hydrogel vehicle on the same side of the body.)
| Study group | Role | What they receive |
|---|---|---|
| Hydrogel vehicle | Experimental | Parallel designed study. Split body treatment Receives: Drug: Hydrogel vehicle |
| Eucerin Lotion | Active comparator | Parallel study design. Split body study. Receives: Drug: Eucerin Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion
The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on targeted area of body half treated with Eucerin lotion
Measured: Day 1 to Day 14
Percent Change of Trans Epidural Water Loss (TEWL) With the Use of Hydrogel Vehicle
The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on target areas of body half treated with Hydrogel vehicle
Measured: Day 1 to Day 14
Secondary outcomes (2)
Percentage of Participants With an Increase in Skin Hydration Using Eucerin Lotion on Targeted Area on One Half of Body
Five timed readings ( 0, 15, 30, 45 and 60 minutes) were taken using the Corneometer 825 meter on subjects using Eucerin lotion on targeted area on one half of body
Measured: Baseline to 14 days
Percentage of Participants With an Increase in Skin Hydration Using Hydrogel Vehicle on Targeted Area of One Half of Body.
Five timed readings at (0, 15, 30, 45 and 60 minutes) were taken, using the Corneometer 825 meter, on participants using Hydrogel vehicle
Measured: Baseline to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derm Research, PLLC
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Leon Kircik, M.D., Derm Research, PLLC
- Investigators
- Leon H. Kirick, M.D., Principal investigator, DermResearch, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065714
- Sponsor's protocol ID
- HGV0901
- Status last verified
- Apr 2013
- First submitted
- 8 Feb 2010
- Last updated
- 25 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transepidermal Water Loss (TEWL) and Corneometry With Hydrogel Vehicle in the Treatment of Atopic Dermatitis - A Randomized, Investigator-Blind Pilot Study
- ClinicalTrials.gov ID
- NCT01065714
- Acronym / sponsor ID
- HGV0901
- Conditions
- Atopic Dermatitis
- Keywords
- Transepidermal water loss, Epidermal barrier, Skin hydration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Derm Research, PLLCUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Feb 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Posted 25 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While the repair of the epidermal barrier in atopic dermatitis is of major importance in the treatment of atopic dermatitis, most of the vehicles used may actually cause a worsening of an impaired epidermal barrier. Hydrogel vehicle is anecdotally known to be moisturizing and hydrating.This study will compare the use of Hydrogel vehicle and Eucerin Lotion in maintaining the epidermal barrier in subjects with atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogel vehicle | Experimental | Drug: Hydrogel vehicleParallel designed study. Split body treatment |
| Eucerin Lotion | Active comparator | Drug: Eucerin LotionParallel study design. Split body study. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Definitive diagnosis of atopic dermatitis as characterized by Hanifin and Rajka criteria:
- 3 out of 4 major characteristics
- At least 3 minor characteristics
- Mild to moderate disease score of 2 or 3 by Investigator Global Assessment
- Minimum 5% Body Surface Area at Baseline
Key exclusion criteria (6 listed)
- Allergy or sensitivity to any component of the test articles.
- Subjects who have not complied with the proper washout periods for prohibited medications.
- Significant coagulation disorder or any medical condition that, in the opinion of the investigator, contraindicates the subject's participation in the study.
- Recent alcohol or drug abuse is evident.
- History of poor cooperation, non-compliance with medical treatment or unreliability
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 |
|---|---|---|
| Hydrogel vehicleEach morning and evening, gently wash the target area with warm water and gently pat dry with soft towel. Once dry place a small amount of Hydrogel vehicle onto the tip of your finger. Place a dab of the Hydrogel vehicle on either the left or right side of the body as instructed. (Do not use Hydrogel vehicle and Eucerin lotion on the same side of the body.) | Drug | Hydrogel vehicle |
| Eucerin LotionEach morning and evening, gently wash the area with warm water and pat dry with a soft towel. Once dry, place a small amount of Eucerin lotion to the target area on either the left or right side of the body as instructed. (Do not use Eucerin and Hydrogel vehicle on the same side of the body.) | Drug | Eucerin Lotion |
Primary outcome
Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion
Time frame: Day 1 to Day 14
The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on targeted area of body half treated with Eucerin lotion
Percent Change of Trans Epidural Water Loss (TEWL) With the Use of Hydrogel Vehicle
Time frame: Day 1 to Day 14
The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on target areas of body half treated with Hydrogel vehicle
2 secondary outcomes
Percentage of Participants With an Increase in Skin Hydration Using Eucerin Lotion on Targeted Area on One Half of Body
Time frame: Baseline to 14 days
Percentage of Participants With an Increase in Skin Hydration Using Hydrogel Vehicle on Targeted Area of One Half of Body.
Time frame: Baseline to 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Leon H. Kirick, M.D. principal investigator
DermResearch, PLLC
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 Eucerin Lotion in people with Atopic Dermatitis, run by Derm Research, PLLC 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 7 inclusion and 6 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 25 Apr 2013. 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?
Yes. Results are posted in the registry (first posted 25 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion (time frame: Day 1 to Day 14). The study lists 2 primary outcomes in all. 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 25 Apr 2013.