Atopic Dermatitis
Conditions
Brief summary
The purpose of this research study is to better understand adherence to Locoid when people use it to treat atopic dermatitis.
Detailed description
An investigator-blinded prospective study of subjects with mild to moderate atopic dermatitis (\>5% Body Surface area and 2 or 3 on the Investigator Global Assessment (IGA) scale). The drug will be used within FDA-approved labeling. Subjects will be randomized to each of the following topical hydrocortisone 17-butyrate 0.1% preparations- ointment, cream or lipocream- in the manufacturer's original tube fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened and this data can be downloaded and tabulated with the associated software. The study will consist of a 2-week Treatment Phase (visits at Baseline and Week 2). Subjects will be instructed to apply the medication twice daily (morning and evening) for 2 weeks to all of their AD lesions. Adherence will be measured by MEMs cap.
Interventions
DRUGhydrocortisone 17-butyrate 0.1% Cream preparation
Apply medication twice a day to affected areas of atopic dermatitis
DRUGhydrocortisone 17-butyrate 0.1% Ointment preparation
Apply medication twice a day to affected areas of atopic dermatitis
DRUGhydrocortisone 17-butyrate 0.1% Lipocream preparation
Apply medication twice a day to affected areas of atopic dermatitis
Sponsors
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 18 years of age. * Subjects must have diagnosis of mild to moderate atopic dermatitis using IGA criteria. (2 or 3 on severity scale) * Subjects must have \>5% TBSA and \<30% to be enrolled. * Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.
Exclusion criteria
* Known allergy or sensitivity to topical Locoid® cream, ointment or lipocream in the subject. * Inability to complete all study-related visits. * Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study. * Requiring \>130 gm of cream in a 2 week period. * Having facial or groin involvement of their disease. * Pregnant women and women who are breast feeding are to be excluded. Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Locoid | 2 weeks | Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from IRB approved advertising and the Dermatology Clinic.
Participants by arm
| Arm | Count |
|---|---|
| Cream topical hydrocortisone 17-butyrate 0.1% cream applied twice daily | 9 |
| Ointment topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily | 7 |
| Lipocream topical hydrocortisone 17-butyrate 0.1% Lipocream applied twice daily | 9 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | Cream | Ointment | Lipocream | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 7 Participants | 9 Participants | 25 Participants |
| Region of Enrollment United States | 9 participants | 7 participants | 9 participants | 21 participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 7 | 0 / 8 |
| other Total, other adverse events | 0 / 6 | 0 / 7 | 0 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 | 0 / 8 |
Outcome results
Primary
Adherence to Locoid
Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cream | Adherence to Locoid | .55 percentage of days | Standard Deviation 0.07 |
| Ointment | Adherence to Locoid | .60 percentage of days | Standard Deviation 0.07 |
| Lipocream | Adherence to Locoid | .50 percentage of days | Standard Deviation 0.07 |