Phase 4
Completed N=129
Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis
Source: ClinicalTrials.gov NCT02340169 ↗Enrolled (actual)
129
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test — 21; 13; 2 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The objective of this study is to evaluate the potential of Topicort® (desoximetasone) Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event profile.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test |
21; 13; 2 | — |
| SECONDARY Adverse Event |
1 | — |
| SECONDARY Cpre-ss |
527.64; 475.41 | — |
Eligibility Criteria
Inclusion Criteria
- Patients aged 7 years and older must have provided written assent accompanied by written informed consent from patient's representative
- Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area (excluding face and scalp)
- Physicians Global Assessment score of 3 or 4 at baseline
Exclusion Criteria
- Has other dermatological conditions that may interfere with clinical assessments
- Allergy or sensitivity to corticosteroids or any drug hypersensitivity or intolerance that would compromise patient safety or study results
- History of an adverse reaction to Cortrosyn™ or similar test reagents
- Chronic infectious disease, system or organ disorder or other medical condition that would place patient at undue risk by study participation
Data sourced from ClinicalTrials.gov (NCT02340169). 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. Informational only — not medical advice.