Atopic Dermatitis
Conditions
Brief summary
The purpose of this research study is to better understand how this study drug works when people use it to treat atopic dermatitis. Desonate has been approved by the US Food and Drug Administration (FDA) for atopic dermatitis.
Detailed description
To assess the efficacy of a desonide hydrogel 0.05% in both young children (age \<13) and older subjects (ages 13 and up) with mild to moderate atopic dermatitis
Interventions
DRUGtopical desonide hydrogel 0.05%
apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions
Sponsors
Wake Forest University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, age 3 months or greater. * Subjects must have diagnosis of mild to moderate atopic dermatitis by an investigator (a 2 or 3 on the IGA scale). * Subjects must have \>2% BSA involvement to be enrolled. * Informed consent of participation must be given by parent or guardian if he or she is \<7 years old. Children who are 7 to 18 years old will be given an assent form to sign. * Moisturizers will be allowed during the study as long as the use remains stable from screening/baseline throughout the study.
Exclusion criteria
* Known allergy or sensitivity to topical desonide hydrogel 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. Other than stable use of over the counter non-medicated moisturizers, all other topical treatments for AD must be stopped prior to study drug initiation. There will be no required washout for any topical therapies. Stable use of systemic therapies may be continued throughout the study. * Requiring \>130 gm of cream in a 4 week period. * Pregnant women and women who are breastfeeding are to be excluded. Women of childbearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control. Use of desonide in pregnant subjects is controversial and is only to be used when benefits outweigh the risks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Assessment at Week 4 | Week 4 | The Investigator global assessment at Week 4 is based on an overall scale of 0-4 with 0 being clear and 4 being very severe |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Topical Desonide Hydrogel 0.05% Approximately 40 male and female subjects (about 20 age 3 months to \<13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD
topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | Topical Desonide Hydrogel 0.05% |
|---|---|
| Age, Continuous | 13 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
Primary
Investigator Global Assessment at Week 4
The Investigator global assessment at Week 4 is based on an overall scale of 0-4 with 0 being clear and 4 being very severe
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Desonide Hydrogel 0.05% | Investigator Global Assessment at Week 4 | 2.3 units on a scale | Standard Deviation 0.5 |