Atopic Dermatitis
Conditions
Keywords
atopic dermatitis, eczema
Brief summary
The purpose of this research study is to better understand how the study drug works when people use it to treat atopic dermatitis.
Detailed description
To evaluate adherence to topical therapy using adherence data collected by the MEMS cap (Medication Electronic Monitoring System) in pediatric patients with atopic dermatitis (AD) and the impact of a return visit.
Interventions
DRUGtacrolimus ointment
tacrolimus ointment to be applied twice daily to affected areas during duration of study
Sponsors
Wake Forest University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects age 2-15. 2. Stable or worsening atopic dermatitis affecting 5% or greater body surface area. Face and genital areas can be included in the body surface area determination and treatment area. 3. The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study. 4. The ability to understand and sign a written informed consent/assent form, which must be obtained prior to treatment.
Exclusion criteria
1. Known allergy to tacrolimus or to any component of the formulations. 2. The use of systemic therapy for atopic dermatitis within the past 4 weeks. 3. Use of prescription topical therapy for atopic dermatitis (e.g., corticosteroids or retinoids) within the past 2 weeks. 4. Use of any investigational therapy within the past 4 weeks. 5. Pregnant females, females who are breast feeding, or females of childbearing potential who are not practicing an acceptable method of birth control (abstinence, birth control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. Acceptable contraception must be used during the entire study. A pregnancy test will be performed on females of childbearing potential at baseline and at week 4. 6. Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | Week 4 | adherence to topical therapy in children via MEMS cap in a real-life clinic population measured as the % of required applications completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The % Change From Baseline to Week 4 (or End of Treatment) in the IGA. | Week 4 | Investigator Global Assessment: Investigator's Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from '0' = clear or No inflammatory signs of AD to '4' = Very Severe Disease with severe erythema and severe papulation/infiltration with oozing/crusting. |
| EASI | Week 4 | Eczema Area and Severity Index (EASI): Disease severity will be assessed by a physician with the Eczema Area and Severity Index (EASI). This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions (which differs for adults and children under 7) and scores erythema, excoriation, induration/papulation, and lichenification. The total scores range from 0-72. Higher scores represent more severe eczema. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from the Dermatology Studies Center and IRB approved advertising.
Participants by arm
| Arm | Count |
|---|---|
| Control Group Group only had visits at Baseline and Week 4. | 15 |
| Extra Visit Group After Baseline, this group had an extra visit at week 1. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Extra Visit Group | Total | Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 15 Participants | 30 Participants | 15 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 15 participants | 30 participants | 15 participants |
| Sex: Female, Male Female | 8 Participants | 17 Participants | 9 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 3 / 15 | 2 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Adherence
adherence to topical therapy in children via MEMS cap in a real-life clinic population measured as the % of required applications completed
Time frame: Week 4
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group | Adherence | 56 percentage of required applicaitons |
| Extra Visit Group | Adherence | 72 percentage of required applicaitons |
Secondary
EASI
Eczema Area and Severity Index (EASI): Disease severity will be assessed by a physician with the Eczema Area and Severity Index (EASI). This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions (which differs for adults and children under 7) and scores erythema, excoriation, induration/papulation, and lichenification. The total scores range from 0-72. Higher scores represent more severe eczema.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | EASI | 2.1 units on a scale | Standard Deviation 5.7 |
| Extra Visit Group | EASI | 1 units on a scale | Standard Deviation 2.6 |
Secondary
The % Change From Baseline to Week 4 (or End of Treatment) in the IGA.
Investigator Global Assessment: Investigator's Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from '0' = clear or No inflammatory signs of AD to '4' = Very Severe Disease with severe erythema and severe papulation/infiltration with oozing/crusting.
Time frame: Week 4
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group | The % Change From Baseline to Week 4 (or End of Treatment) in the IGA. | -33 % change in IGA |
| Extra Visit Group | The % Change From Baseline to Week 4 (or End of Treatment) in the IGA. | -33 % change in IGA |