Atopic Dermatitis
Conditions
Brief summary
A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.
Interventions
DRUGFluticasone propionate 0.05% lotion
Daily applications
Sponsors
Fougera Pharmaceuticals Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 12 Months
Healthy volunteers
No
Inclusion criteria
* Subjects are 3-12 months of age * Subjects diagnosed with Atopic Dermatitis (AD) and have ≥35% of Body Surface Area * Subjects meet protocol specific AD signs and symptom severity score
Exclusion criteria
* Subjects with conditions effecting the HPA Axis * Subjects with clinically significant systemic disease * Subjects who require treatment with systemic or topical retinoids during the study * Subjects who have been treated with various chronic therapies identified in the protocol * Subjects who have received other investigational drug treatment within 30 days prior to study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Treatment Serum Cortisol Values Will be Compared. | Up to 29 days of treatment | The primary safety parameter was the response to the CST at the end of treatment/final visit. Blood samples were collected prior to injection of cosyntropin and post-injection. Post-CST stimulation cortisol level ≤ 18micrograms/dL was considered as evidence of adrenal suppression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity | Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29 | The frequency distributions of the presence/absence of adverse events associated with signs of atrophy and pigmentation changes were summarized with frequency counts. Hematology and Chemistry Assessments were summarized in shift tables. Signs and symptoms of AD were summarized at each visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Receive between 22 and 29 days of Cutivate lotion treatment
Fluticasone propionate 0.05% lotion: Daily applications | 56 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Baseline HPA Axis Supression | 2 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Experimental |
|---|---|
| Age, Continuous | 7.2 Months STANDARD_DEVIATION 2.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 participants |
| Race (NIH/OMB) Asian | 7 participants |
| Race (NIH/OMB) Black or African American | 31 participants |
| Race (NIH/OMB) More than one race | 7 participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 participants |
| Race (NIH/OMB) White | 19 participants |
| Region of Enrollment United States | 56 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / 56 |
| serious Total, serious adverse events | 1 / 56 |
Outcome results
Primary
Post Treatment Serum Cortisol Values Will be Compared.
The primary safety parameter was the response to the CST at the end of treatment/final visit. Blood samples were collected prior to injection of cosyntropin and post-injection. Post-CST stimulation cortisol level ≤ 18micrograms/dL was considered as evidence of adrenal suppression.
Time frame: Up to 29 days of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental | Post Treatment Serum Cortisol Values Will be Compared. | 1 participants |
Secondary
Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity
The frequency distributions of the presence/absence of adverse events associated with signs of atrophy and pigmentation changes were summarized with frequency counts. Hematology and Chemistry Assessments were summarized in shift tables. Signs and symptoms of AD were summarized at each visit.
Time frame: Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental | Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity | pigmentation change | 9 participants |
| Experimental | Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity | skin atrophy | 1 participants |