Using Enstilar with Enbrel or Humira for treating 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
This study is testing if using a foam treatment called Enstilar along with Enbrel or Humira can help people with chronic plaque psoriasis improve their skin condition.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Psoriasis Treatment Center of Central New Jersey Academic / other |
| Drugs / interventions | adalimumab |
| Locations | 1 site (East Windsor, New Jersey) |
| Trial ID | NCT03827876 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Enstilar, a topical foam, when used in conjunction with etanercept (Enbrel) or adalimumab (Humira) for patients with chronic plaque psoriasis. Participants will receive Enstilar once daily for the first four weeks, followed by every other day for an additional twelve weeks. The study focuses on patients who have been on etanercept or adalimumab for at least 24 weeks and have a body surface area involvement of 2-10%. The goal is to assess improvements in skin condition and overall patient assessment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic plaque psoriasis affecting 2-10% of their body surface area who have been treated with etanercept or adalimumab for at least 24 weeks.
Not a fit: Patients with less than 2% or more than 10% body surface area involvement, or those not receiving etanercept or adalimumab for the required duration, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes for patients with plaque psoriasis who are already on systemic therapies.
How similar studies have performed: While there have been studies on the individual effectiveness of Enstilar and systemic therapies, this specific combination approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
East Windsor, New Jersey
- Psoriasis Treatment Center of Central New Jersey — East Windsor, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Jerry Bagel, MD
- Email: dreamacres1@aol.com
- Phone: 6094434500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.