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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open Label, Safety Study to Assess the Potential for Adrenal Suppression and Pharmacokinetics Following Maximal Use Treatment With Topicort® (Desoximetasone) Topic

Brief 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.

Detailed Summary: 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.
Sponsor: Taro Pharmaceuticals USA

Current Primary Outcome: Hypothalmic pituitary adrenal axis function suppression as measured by Cortisol Response Test [ Time Frame: 28 days ]

A patient will be considered to have potential HPA axis suppression if they meet at least one of the criteria:

  • their 30 minute post injection cortisol level is not at least 7 mcg/100 ml greater than the basal level (< basal + 7)
  • the post stimulation level is ≤ 18 mcg/100 ml


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluate efficacy parameters as measured by change from baseline in clinical signs and symptoms (erythema, scaling, plaque elevation) and the PGA score at baseline and end of treatment [ Time Frame: 28 days ]
  • Evaluate pharmacokinetics as measured by Cmax-ss [ Time Frame: 28 days ]
    Evaluate pharmacokinetics as measured by the peak exposure at steady state (Cmax-ss)
  • Evaluate pharmacokinetics as measured by Tmax-ss [ Time Frame: 28 days ]
    Evaluate pharmacokinetics as measured by the steady-state time to peak exposure (Tmax-ss)
  • Evaluate pharmacokinetics as measured by Kel [ Time Frame: 28 days ]
    Evaluate pharmacokinetics as measured by the apparent elimination rate constant (Kel)
  • Evaluate pharmacokinetics as measured by AUCss [ Time Frame: 28 days ]
    Evaluate pharmacokinetics as measured by steady-state area under the plasma concentration-time curve (AUCss)
  • Evaluate pharmacokinetics as measured by T½ [ Time Frame: 28 days ]
    Evaluate pharmacokinetics as measured by the terminal half-life (T½) will be estimated as ln(2)/Kel
  • Evaluate adverse event profile [ Time Frame: 28 days ]


Original Secondary Outcome: Same as current

Information By: Taro Pharmaceuticals USA

Dates:
Date Received: December 28, 2014
Date Started: January 23, 2015
Date Completion: April 2019
Last Updated: May 3, 2017
Last Verified: May 2017