Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enstilar 0.005%-0.064% Topical Foam.
- Who it may be relevant to
- Registry conditions: Psoriasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- 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
Primary outcome measures
- PGA x BSA improvement [Time frame: 16 weeks]
Secondary outcome measures (3)
- BSA improvement [Time frame: 16 weeks]
- Dermatology Life Quality Index improvement [Time frame: 16 weeks]
- Itch Numerical Rating Scale [Time frame: 16 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Psoriasis Treatment Center of Central New Jersey — East Windsor
Identifiers
NCT: NCT03827876 · PTC04