Atopic Dermatitis, Psoriasis
Conditions
Keywords
Psoriasis, Atopic Dermatitis
Brief summary
The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface area.
Interventions
DRUGPandel Cream 0.1%
A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of psoriasis or atopic dermatitis involving more than 20% of body surface area * Good health with the exception of psoriasis or atopic dermatitis
Exclusion criteria
* Any disease affecting the HPA-axis * Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-injection Serum Cortisol Level | 22 Days | The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-injection Serum Cortisol Levels | 22 Days | The number of subjects with pre-injection serum cortisol levels less than or equal to 5 ug/dL Day 22. |
| and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL. | 22 days | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pandel Cream 0.1% Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Pandel Cream 0.1% |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 48.3 years |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Post-injection Serum Cortisol Level
The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22.
Time frame: 22 Days
Population: 15 subjects represents the subgroup utilized for the analysis of this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pandel Cream 0.1% | Post-injection Serum Cortisol Level | 1 participants |
Secondary
and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL.
Time frame: 22 days
Population: 15 subjects represents the subgroup utilized for the analysis of this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pandel Cream 0.1% | and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL. | 1 participants |
Secondary
Pre-injection Serum Cortisol Levels
The number of subjects with pre-injection serum cortisol levels less than or equal to 5 ug/dL Day 22.
Time frame: 22 Days
Population: 15 subjects represents the subgroup utilized for the analysis of this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pandel Cream 0.1% | Pre-injection Serum Cortisol Levels | 0 participants |