The Maintenance Effect of Enstilar Foam in Combination With Otezla

NCT ID: NCT04555707

Last Updated: 2020-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-24
• Study Completion Date: 2021-09-30

Brief Summary

This is a single-center, open-label study. Approximately 30 qualified subjects will be enrolled in a study lasting 20 weeks which investigates the effect of Enstilar used in combination with Otezla to treat psoriasis.

Detailed Description

Approximately 30 subjects will be enrolled in a single-center, open-label study of the treatment of psoriasis. There will be a screening/baseline, week 4, week 16 and week 20 visits. Subjects will include those who have been started on commercial Otezla within the last 10 days of baseline. We will add Enstilar foam QD at baseline visit for 4 weeks. Those subjects who achieve clear or almost clear on PGA scale at week 4 will continue on maintenance dose of Enstilar twice weekly on Mondays and Thursdays QD for the next 12 weeks and they will also continue on Otezla. Subjects will continue to week 20 after stopping Enstilar at week 16..

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Otezla + Enstilar

Group Type: EXPERIMENTAL

Apremilast 30mg

Intervention Type: DRUG

30mg PO BID started within 10 days of baseline

calcipotriene and betamethasone dipropionate

Intervention Type: DRUG

1 application daily starting at baseline and continuing for 4 weeks; those achieving clear or almost clear PGA at week 4 will continue application twice weekly on Monday and Thursday in combination with Otezla. Enstilar application is discontinued at week 16 and study participation continues until week 20.

Interventions

Apremilast 30mg

30mg PO BID started within 10 days of baseline

Intervention Type: DRUG

calcipotriene and betamethasone dipropionate

1 application daily starting at baseline and continuing for 4 weeks; those achieving clear or almost clear PGA at week 4 will continue application twice weekly on Monday and Thursday in combination with Otezla. Enstilar application is discontinued at week 16 and study participation continues until week 20.

Intervention Type: DRUG

Other Intervention Names

Otezla; Enstilar

Eligibility Criteria

Inclusion Criteria

1. Outpatient, male or female subjects of any race, 18 years of age or higher. Female subjects of childbearing potential must have a (-)UPT result at within 7 days of the first dose of study drug and practice a reliable method of contraception throughout the study;

A female is considered of childbearing potential unless she is:

• postmenopausal > 5Y, without a uterus and/or both ovaries; or has been surgically sterile for > 6M.

Reliable methods of contraception are:

• hormonal methods or IUD in use > 90d prior to study drug administration, barrier methods plus spermicide in use > 14d prior, or vasectomized partner.

[Exception: Female subjects of CBP who are not sexually active are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided they are counseled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.]

2. Subjects with moderate plaque type psoriasis who have been started on commercial Otezla within the last 10 days

3. Physician Global Assessment (PGA) score of 3

4. Able to understand study requirements and sign Informed Consent/HIPAA forms

Exclusion Criteria

1. Female subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control, or male subjects planning a pregnancy with their spouse or partner while in the study

2. History of hypercalcemia or Vitamin D toxicity or history of significant renal or hepatic disease

3. Patients with guttate, erythrodermic, or pustular psoriasis

4. Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator.)

5. Skin conditions (e.g. eczema) that may interfere with evaluations of psoriasis

6. Known hypersensitivity to Enstilar Foam or any of its components

7. Current drug or alcohol abuse (Investigator opinion.)

8. Subject unable to commit to all the assessments required by the protocol

9. Current enrollment in another clinical study and treatment with another experimental drug or approved therapy for experimental use within 30 days prior to the Screening Visit.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Derm Research, PLLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

L.H. Kircik, M.D.

Role: PRINCIPAL_INVESTIGATOR

Skin Sciences, PLLC

Locations

Skin Sciences, PLLC

Louisville, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Senen Pena Oliva

Role: CONTACT

spdermresearch@yahoo.com

502-451-9000

Leon H Kircik, MD

Role: CONTACT

wedoderm@yahoo.com

502-451-9000

Facility Contacts

Senen Pena Oliva, MSN

Role: primary

spdermresearch@yahoo.com

502-451-9000

Other Identifiers

ENS-2001

Identifier Type: -

Identifier Source: org_study_id