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Enstilar in Combination With Biologic Agents

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Enstilar 0.005%-0.064% Topical Foam
Sponsored by
Psoriasis Treatment Center of Central New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female adults ≥ 18 years of age.
  2. Diagnosis of chronic plaque-type psoriasis.
  3. Able to give written informed consent prior to performance of any study related procedures.
  4. Treated with a biologic agent for a minimum of 24 weeks at baseline.
  5. Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%.
  6. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
  7. Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.

Exclusion Criteria:

  1. >5% Body Surface Area
  2. Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
  3. Pregnant or breast feeding, or considering becoming pregnant during the study.
  4. Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
  5. Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
  6. Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
  7. Patient received UVB phototherapy within 2 weeks of Baseline.
  8. Patient received PUVA phototherapy within 4 weeks of Baseline.
  9. Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label.

Sites / Locations

  • Psoriasis Treatment Center of Central New Jersey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label Enstilar

Arm Description

open label

Outcomes

Primary Outcome Measures

Physician global assessment multiplied by body surface area improvement after 16 weeks of Enstilar® adjunctive therapy
pga x bsa

Secondary Outcome Measures

Physician Global Assessment
PGA
Body Surface area
BSA
dermatology life quality index; TSQ-9 Treatment Satisfaction Questionnaire
satisfaction determined by patient reported outcomes

Full Information

First Posted
March 2, 2017
Last Updated
December 29, 2017
Sponsor
Psoriasis Treatment Center of Central New Jersey
Collaborators
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03080545
Brief Title
Enstilar in Combination With Biologic Agents
Official Title
An Open-Label, Study Evaluating Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Biologic Agents
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Psoriasis Treatment Center of Central New Jersey
Collaborators
LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients receiving biologic therapy with 5% or less body surface area will receive Enstilar topical foam for 16 weeks.
Detailed Description
A two-phase, single center, observational study of 25 subjects to assess 4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QD on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label Enstilar
Arm Type
Experimental
Arm Description
open label
Intervention Type
Drug
Intervention Name(s)
Enstilar 0.005%-0.064% Topical Foam
Intervention Description
Topical foam
Primary Outcome Measure Information:
Title
Physician global assessment multiplied by body surface area improvement after 16 weeks of Enstilar® adjunctive therapy
Description
pga x bsa
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Physician Global Assessment
Description
PGA
Time Frame
16 weeks
Title
Body Surface area
Description
BSA
Time Frame
16 weeks
Title
dermatology life quality index; TSQ-9 Treatment Satisfaction Questionnaire
Description
satisfaction determined by patient reported outcomes
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female adults ≥ 18 years of age. Diagnosis of chronic plaque-type psoriasis. Able to give written informed consent prior to performance of any study related procedures. Treated with a biologic agent for a minimum of 24 weeks at baseline. Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide. Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination. Exclusion Criteria: >5% Body Surface Area Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study. Pregnant or breast feeding, or considering becoming pregnant during the study. Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer). Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine). Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids). Patient received UVB phototherapy within 2 weeks of Baseline. Patient received PUVA phototherapy within 4 weeks of Baseline. Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label.
Facility Information:
Facility Name
Psoriasis Treatment Center of Central New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Enstilar in Combination With Biologic Agents

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