Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis

Overview

4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QOD to patients with 2-10% BSA who are receiving etanercept or adalimumab for at least 24 weeks

Full Title of Study: “An Open-Label Study Evaluating Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Etanercept or Adalimumab”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 15, 2019

Detailed Description

30 subjects treated with etanercept or adalimumab for at least 24 weeks with a body surface area 2-10% and physician global assessment greater than or equal to 2 will receive Enstilar® once daily for 4 weeks followed by QOD for 12 weeks.

Interventions

  • Drug: Enstilar 0.005%-0.064% Topical Foam
    • Enstilar 0.005%-0.064% Topical Foam applied once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira

Arms, Groups and Cohorts

  • Experimental: Open Label Enstilar
    • once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira

Clinical Trial Outcome Measures

Primary Measures

  • PGA x BSA improvement
    • Time Frame: 16 weeks
    • body surface area multiplied by physician global assessment

Secondary Measures

  • BSA improvement
    • Time Frame: 16 weeks
    • body surface area improvement
  • Dermatology Life Quality Index improvement
    • Time Frame: 16 weeks
    • patient reported outcome improvements of DLQI (Dermatology Life Quality Index). Calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
  • Itch Numerical Rating Scale
    • Time Frame: 16 weeks
    • Patient reported itch scale from 0 (no itch) to 10 (worst imaginable itch).

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female adult ≥ 18 years of age;
  • Diagnosis of chronic plaque-type
  • Patient with 2-10% BSA
  • Physician Global Assessment of 2 or greater
  • Patient has been treated with etanercept or adalimumab for a minimum of 24 weeks

Exclusion Criteria

  • ˂2 or >10% BSA
  • PGA <2
  • Patient not receiving etanercept or adalimumab, or receiving etanercept or adalimumab <24weeks

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Psoriasis Treatment Center of Central New Jersey
  • Collaborator
    • LEO Pharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Jerry Bagel, MD, 6094434500, dreamacres1@aol.com

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