A Phase 4 interventional study of tacrolimus ointment in Atopic Dermatitis, sponsored by Wake Forest University. Completed at 1 site in United States. Open to participants aged 2 Years to 15 Years. Per ClinicalTrials.gov, last updated 2018-08-01.
Sponsored by Wake Forest University · Phase 4, Interventional, and Treatment
The purpose of this research study is to better understand how the study drug works when people use it to treat atopic dermatitis.
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 30 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Wake Forest University is the lead sponsor of 116 studies on the registry; 7 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 27 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
tacrolimus ointment
Drug: tacrolimus ointment
tacrolimus ointment to be applied twice daily to affected areas during duration of study
Also known as: Protopic Ointment
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
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
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
Subjects were recruited from the Dermatology Studies Center and IRB approved advertising.
| Milestone | Control Group | Extra Visit Group |
|---|---|---|
| Started | 15 | 15 |
| Completed | 13 | 13 |
| Not completed | 2 | 2 |
| Withdrew: Lost to follow-up | 2 | 2 |
adherence to topical therapy in children via MEMS cap in a "real-life" clinic population measured as the % of required applications completed
| percentage of required applicaitons | Control Group | Extra Visit Group |
|---|---|---|
| Adherence | 56 (15 to 79) | 72 (39 to 114) |
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."
| % change in IGA | Control Group | Extra Visit Group |
|---|---|---|
| The % Change From Baseline to Week 4 (or End of Treatment) in the IGA. | -33 (-44 to -18) | -33 (-54 to -30) |
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.
| units on a scale | Control Group | Extra Visit Group |
|---|---|---|
| EASI | 2.1 ± 5.7 | 1 ± 2.6 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | 0/15 (0%) | 0/15 (0%) | 3/15 (20%) |
| Extra Visit Group | 0/15 (0%) | 0/15 (0%) | 2/15 (13.3%) |
| Event | Control Group | Extra Visit Group |
|---|---|---|
| Upper respiratory InfectionRespiratory, thoracic and mediastinal disorders | 3/15 | 2/15 |
| Age, Categorical(Participants) | Control Group | Extra Visit Group | Total |
|---|---|---|---|
| <=18 years | 15 | 15 | 30 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Control Group | Extra Visit Group | Total |
|---|---|---|---|
| Female | 9 | 8 | 17 |
| Male | 6 | 7 | 13 |
| Region of Enrollment(participants) | Control Group | Extra Visit Group | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
Plan to share: No
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Wake Forest University