Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03827876

Enrollment

Registered

2019-02-04

Start date

2019-01-16

Completion date

2019-12-15

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

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.

Interventions

DRUGEnstilar 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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

open label

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
PGA x BSA improvement	16 weeks	body surface area multiplied by physician global assessment

Secondary

Measure	Time frame	Description
BSA improvement	16 weeks	body surface area improvement
Dermatology Life Quality Index improvement	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	16 weeks	Patient reported itch scale from 0 (no itch) to 10 (worst imaginable itch).

Countries

United States

Contacts

Primary ContactJerry Bagel, MD

dreamacres1@aol.com6094434500

Backup ContactElise Nelson

enelson@windsordermatology.com6094434500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026