Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis
| Status: | Recruiting |
|---|---|
| Conditions: | Psoriasis |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 2 - 17 |
| Updated: | 2/1/2018 |
| Start Date: | January 23, 2015 |
| End Date: | December 2018 |
| Contact: | Taro Pharmaceuticals U.S.A. Inc. |
| Phone: | +1 914-345-900 |
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression and Pharmacokinetics Following Maximal Use Treatment With Topicort® (Desoximetasone) Topical Spray, 0.25% in Pediatric Patients With Plaque Psoriasis.
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.
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.
An open label, post marketing safety study to assess the potential of a TOPICORT®
(desoximetasone) Topical Spray, 0.25% to suppress HPA axis function following twice daily
dosing for 28 days.
(desoximetasone) Topical Spray, 0.25% to suppress HPA axis function following twice daily
dosing for 28 days.
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
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