NCT03827876

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

January 29, 2019

Last Update Submit

January 31, 2019

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • PGA x BSA improvement

    body surface area multiplied by physician global assessment

    16 weeks

Secondary Outcomes (3)

  • BSA improvement

    16 weeks

  • Dermatology Life Quality Index improvement

    16 weeks

  • Itch Numerical Rating Scale

    16 weeks

Study Arms (1)

Open Label Enstilar

EXPERIMENTAL

once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira

Drug: Enstilar 0.005%-0.064% Topical Foam

Interventions

Enstilar 0.005%-0.064% Topical FoamDRUG

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

Open Label Enstilar

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

betamethasone dipropionate, calcipotriol drug combination

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Jerry Bagel, MD

CONTACT

6094434500dreamacres1@aol.com

Elise Nelson

CONTACT

6094434500enelson@windsordermatology.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: open label
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2019

First Posted

February 4, 2019

Study Start

January 16, 2019

Primary Completion

September 15, 2019

Study Completion

December 15, 2019

Last Updated

February 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)