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Duobrii in Combination With Biologics

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ClinicalTrials.gov Identifier: NCT04119102
Recruitment Status : Unknown
Verified April 2020 by Psoriasis Treatment Center of Central New Jersey.
Recruitment status was:  Recruiting
First Posted : October 8, 2019
Last Update Posted : April 30, 2020
Sponsor:
Collaborator:
Ortho Dermatologics
Information provided by (Responsible Party):
Psoriasis Treatment Center of Central New Jersey

Study Description
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Brief Summary:
12 weeks DUOBRII to patients with 2%-10% BSA who are receiving biologic therapy for at least 24 weeks

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Duobrii Phase 4

Detailed Description:
A single center, pilot study of 25 subjects to assess 12 weeks DUOBRII to patients with 2%-10% body surface area who are receiving biologic therapy for at least 24 weeks
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study Evaluating DUOBRII in Psoriasis Patients Being Treated With Biologic Agents.
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Open Label Duobrii
Duobrii QD
 Drug: Duobrii
duobrii applied daily for 4 weeks followed by every other day for 4 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Body surface area improvement [ Time Frame: 8 weeks ]
    body surface area determined by palm method where 1 palm is equivalent to 1%


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female adult ≥ 18 years of age;
  2. Diagnosis of chronic plaque-type
  3. Psoriasis affecting 2%-10% BSA
  4. Patient is being treated with biologic therapy for a minimum of 24 weeks
  5. Able and willing to give written informed consent prior to performance of any study-related procedures

Exclusion Criteria:

  1. Psoriasis affecting ˂2% or >10% BSA
  2. Patient not receiving a biologic agent, or receiving biologic agent <24weeks
  3. Received treatment with any topical antipsoriatic drug product within 14 days prior to the Baseline visit.
  4. Has previously used DUOBRII
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119102


Contacts
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Contact: Jerry Bagel, MD 6094434500 dreamacres1@aol.com
Contact: Elise Nelson 6094434500 enelson@windsordermatology.com

Locations
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United States, New Jersey
Psoriasis Treatment Center of Central New Jersey Recruiting
East Windsor, New Jersey, United States, 08520
Contact: Elise Nelson    609-443-4500 ext 1402    enelson@windsordermatology.com   
Principal Investigator: Jerry Bagel, MD         
Sub-Investigator: Brian Keegan, MD, PhD         
Sub-Investigator: David Nieves, MD         
Sub-Investigator: Alexa Hetzel, PA-C         
Sponsors and Collaborators
Psoriasis Treatment Center of Central New Jersey
Ortho Dermatologics
More Information
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Responsible Party: Psoriasis Treatment Center of Central New Jersey
ClinicalTrials.gov Identifier: NCT04119102    
Other Study ID Numbers: PTC07
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases