Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis

Description

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.

Study Start Date

December 2014

Estimated Completion Date

April 2016

Interventions

  • Drug: Topicort® (desoximetasone) Topical Spray, 0.25%
  • Drug: Topicort® (desoximetasone) Topical Spray, 0.25%

Specialties

  • Pharmacy: Antimicrobials
  • Dermatology: Clinical Pharmacology,Psoriasis
  • Physician Assistant: Dermatology

MeSH Terms

  • Plaque Psoriasis
  • Psoriasis

Study ID

Taro Pharmaceuticals USA -- DSXS-1303

Status

Unknown

Trial ID

NCT02340169

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

100

Sponsor

Taro Pharmaceuticals USA

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

Gender

Both

Ages

2 Years to 17 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Taro Pharmaceuticals USA Inc - Hawthorne, New York 29.6 miles Natalie Yantovskiy None None

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