Phase 4
N=19
Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population
Psoriasis · Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT01137032 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Post-injection Serum Cortisol Level — 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pandel Cream 0.1% (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Fougera Pharmaceuticals Inc.
- Primary completion
- Aug 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-injection Serum Cortisol Level |
1 | — |
| SECONDARY Pre-injection Serum Cortisol Levels |
— | — |
| SECONDARY and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL. |
1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01137032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.