The Maintenance Effect of Enstilar Foam in Combination With Otezla

NCT04555707 | Unknown Phase 4 FDA Drug

• 1 other identifier: ENS-2001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percent of subjects who are clear or almost clear on Physicians Global Assessment at Week 4

  Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate

  4 weeks

Secondary Outcomes (7)

• Percent of subjects who are clear or almost clear at week 4, 16 and week 20 on Physicians Global Assessment

  week 4, week 16, week 20

• The percent of subjects who are clear or almost clear at week 4, 16 and week 20 on Patient Global Assessment

  week 4, week 16, week 20

• Percent of subjects who achieve PASI (psoriasis area and severity index) 75 at week 4

  4 weeks

• Percent of subjects who achieve PASI 75 at week 16

  16 weeks

• DLQI (dermatology life quality index) at week 4

  4 weeks

Study Arms (1)

Otezla + Enstilar

EXPERIMENTAL

Drug: Apremilast 30mg; Drug: calcipotriene and betamethasone dipropionate

Interventions

Apremilast 30mg DRUG

30mg PO BID started within 10 days of baseline

Also known as: Otezla

Otezla + Enstilar

calcipotriene and betamethasone dipropionate 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.

Also known as: Enstilar

Otezla + Enstilar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \[Exception: Female subjects of CBP who are not sexually active are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided they are counseled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.\]
• Subjects with moderate plaque type psoriasis who have been started on commercial Otezla within the last 10 days
• Physician Global Assessment (PGA) score of 3
• Able to understand study requirements and sign Informed Consent/HIPAA forms

You may not qualify if:

• 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
• History of hypercalcemia or Vitamin D toxicity or history of significant renal or hepatic disease
• Patients with guttate, erythrodermic, or pustular psoriasis
• Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator.)
• Skin conditions (e.g. eczema) that may interfere with evaluations of psoriasis
• Known hypersensitivity to Enstilar Foam or any of its components
• Current drug or alcohol abuse (Investigator opinion.)
• Subject unable to commit to all the assessments required by the protocol
• 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.

Sponsors & Collaborators

• Derm Research, PLLC: lead

Study Sites (1)

Skin Sciences, PLLC

Louisville, Kentucky, 40217, United States

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

apremilast; betamethasone dipropionate, calcipotriol drug combination

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• L.H. Kircik, M.D.

  Skin Sciences, PLLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Senen Pena Oliva

CONTACT

502-451-9000; spdermresearch@yahoo.com

Leon H Kircik, MD

CONTACT

502-451-9000; wedoderm@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 21, 2020
• Study Start: June 24, 2020
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)