Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03827876
• Other study ID #: PTC04
• Status: Recruiting
• Phase: Phase 4
• Start date: January 16, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: January 2019
• Source: Psoriasis Treatment Center of Central New Jersey
• Contact: Jerry Bagel, MD
• Phone: 6094434500
• Email: dreamacres1[@]aol.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 15, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
United States	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Psoriasis Treatment Center of Central New Jersey	LEO Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PGA x BSA improvement	body surface area multiplied by physician global assessment	16 weeks
Secondary	BSA improvement	body surface area improvement	16 weeks
Secondary	Dermatology Life Quality Index improvement	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.	16 weeks
Secondary	Itch Numerical Rating Scale	Patient reported itch scale from 0 (no itch) to 10 (worst imaginable itch).	16 weeks