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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrogel vehicle | Experimental | Parallel designed study. Split body treatment |
|
| Eucerin Lotion | Active Comparator | Parallel study design. Split body study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogel vehicle | Drug | 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Day 1 to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leon H. Kirick, M.D. | DermResearch, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DermResearch, PLLC | Louisville | Kentucky | 40217 | United States |
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Recruitment from March 2010 through September 2010. Subjects enrolled from physician data base.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydrogel Vehicle/Eucerin Lotion | Parallel designed study. Split body treatment. Eucerin Lotion applied to one side of body, Hydrogel applied to the opposite side of body. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydrogel Vehicle/Eucerin Lotion | Parallel designed study. Split body treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | per protocol | Posted | Median | Full Range | percent change | Day 1 to Day 14 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hydrogel Vehicle/Eucerin Lotion | Parallel designed study. Split body treatment |
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Small number of participants, pilot study, short term
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leon Kircik, M.D. | DermResearch, PLLC | 502-451-9000 | wedoderm@yahoo.com |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D020100 | Hydrogels |
| ID | Term |
|---|---|
| D005782 | Gels |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 |
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| Eucerin Lotion | Drug | 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.) |
|
| 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 |
| Baseline to 14 days |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | 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 | Per protocol | Posted | Median | Full Range | percent change | Day 1 to Day 14 |
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|
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| Secondary | 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 | per protocol | Posted | Mean | Standard Deviation | Percentage of participants | Baseline to 14 days |
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|
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| Secondary | 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 | per protocol | Posted | Mean | Standard Deviation | percentage of participants | Baseline to 14 days |
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| 0 |
| 20 |
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| 20 |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Pharmaceutical Preparations |