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Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT03827876
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
Psoriasis Treatment Center of Central New Jersey

Tracking Information
First Submitted Date  ICMJE January 29, 2019
First Posted Date  ICMJE February 4, 2019
Last Update Posted Date February 4, 2019
Actual Study Start Date  ICMJE January 16, 2019
Estimated Primary Completion Date September 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
PGA x BSA improvement [ Time Frame: 16 weeks ]
body surface area multiplied by physician global assessment
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis
Official Title  ICMJE 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
Brief Summary 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
open label
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Open Label Enstilar
once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira
Intervention: Drug: Enstilar 0.005%-0.064% Topical Foam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2019
Estimated Primary Completion Date September 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jerry Bagel, MD 6094434500 dreamacres1@aol.com
Contact: Elise Nelson 6094434500 enelson@windsordermatology.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03827876
Other Study ID Numbers  ICMJE PTC04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Psoriasis Treatment Center of Central New Jersey
Study Sponsor  ICMJE Psoriasis Treatment Center of Central New Jersey
Collaborators  ICMJE LEO Pharma
Investigators  ICMJE Not Provided
PRS Account Psoriasis Treatment Center of Central New Jersey
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP