Enstilar in Combination With Biologic Agents

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 Biologic Agents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080545
• Other study ID #: PTC01
• Status: Completed
• Phase: Phase 4
• First received: March 2, 2017
• Last updated: December 29, 2017
• Start date: May 1, 2017
• Est. completion date: October 30, 2017

Study information

• Verified date: December 2017
• Source: Psoriasis Treatment Center of Central New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients receiving biologic therapy with 5% or less body surface area will receive Enstilar topical foam for 16 weeks.

Description:

A two-phase, single center, observational study of 25 subjects to assess 4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QD on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female adults = 18 years of age.

2. Diagnosis of chronic plaque-type psoriasis.

3. Able to give written informed consent prior to performance of any study related procedures.

4. Treated with a biologic agent for a minimum of 24 weeks at baseline.

5. Plaque-type psoriasis as defined at screening and baseline by BSA = 5%.

6. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.

7. Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.

Exclusion Criteria:

1. >5% Body Surface Area

2. Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.

3. Pregnant or breast feeding, or considering becoming pregnant during the study.

4. Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).

5. Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).

6. Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).

7. Patient received UVB phototherapy within 2 weeks of Baseline.

8. Patient received PUVA phototherapy within 4 weeks of Baseline.

9. Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Enstilar 0.005%-0.064% Topical Foam
Topical foam

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	Physician global assessment multiplied by body surface area improvement after 16 weeks of Enstilar® adjunctive therapy	pga x bsa	16 weeks
Secondary	Physician Global Assessment	PGA	16 weeks
Secondary	Body Surface area	BSA	16 weeks
Secondary	dermatology life quality index; TSQ-9 Treatment Satisfaction Questionnaire	satisfaction determined by patient reported outcomes	16 weeks