Recruiting

Enstilar & Enbrel

Sponsor:

Psoriasis Treatment Center of Central New Jersey

Code:

NCT03827876

Conditions

Psoriasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enstilar 0.005%-0.064% Topical Foam

Study Details

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

Conditions

Psoriasis

Study ID

NCT03827876

Start date

Jan 16, 2019

Status verified date

Jan, 2019

Completion date

Dec 15, 2019

Anticipated

Primary completion date

Sep 15, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open Label Enstilar

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

Interventions

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 measure

  • PGA x BSA improvement [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Jerry Bagel, MD

6094434500dreamacres1@aol.com

Elise Nelson

6094434500enelson@windsordermatology.com

Locations

Psoriasis Treatment Center of Central New Jersey

Recruiting

East Windsor, New Jersey, United States, 08520

Contacts

Elise Nelson

609-443-4500enelson@windsordermatology.com

Principal Investigator:

Jerry Bagel, MD

More Information

Sponsor

Psoriasis Treatment Center of Central New Jersey

Last update posted

Feb 4, 2019

Last verified

Jan, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Psoriasis Treatment Center of Central New Jersey on 2019-02-04.