Atopic Dermatitis
Conditions
Keywords
Transepidermal water loss, Epidermal barrier, Skin hydration
Brief 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. 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.
Interventions
DRUGHydrogel vehicle
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.)
DRUGEucerin Lotion
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.)
Sponsors
Bayer
Derm Research, PLLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Increase in Skin Hydration Using Eucerin Lotion on Targeted Area on One Half of Body | Baseline to 14 days | 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 |
| Percentage of Participants With an Increase in Skin Hydration Using Hydrogel Vehicle on Targeted Area of One Half of Body. | Baseline to 14 days | Five timed readings at (0, 15, 30, 45 and 60 minutes) were taken, using the Corneometer 825 meter, on participants using Hydrogel vehicle |
Countries
United States
Participant flow
Recruitment details
Recruitment from March 2010 through September 2010. Subjects enrolled from physician data base.
Participants by arm
| Arm | Count |
|---|---|
| Hydrogel Vehicle/Eucerin Lotion Parallel designed study. Split body treatment | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Hydrogel Vehicle/Eucerin Lotion |
|---|---|
| Age, Categorical <=18 years | 4 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age Continuous | 35 years STANDARD_DEVIATION 16 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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
Time frame: Day 1 to Day 14
Population: per protocol
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Skin Barrier Function With Eucerin Lotion | Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion | 21.4 percent change | Full Range 54.8 |
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
Time frame: Day 1 to Day 14
Population: Per protocol
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Skin Barrier Function With Eucerin Lotion | Percent Change of Trans Epidural Water Loss (TEWL) With the Use of Hydrogel Vehicle | 4.2 percent change | Full Range 31.2 |
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
Time frame: Baseline to 14 days
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skin Barrier Function With Eucerin Lotion | Percentage of Participants With an Increase in Skin Hydration Using Eucerin Lotion on Targeted Area on One Half of Body | 33.5 Percentage of participants | Standard Deviation 72.2 |
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
Time frame: Baseline to 14 days
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skin Barrier Function With Eucerin Lotion | Percentage of Participants With an Increase in Skin Hydration Using Hydrogel Vehicle on Targeted Area of One Half of Body. | 32.3 percentage of participants | Standard Deviation 51.5 |