Recruiting

Enstilar & Otezla

Sponsor:

Derm Research, PLLC

Code:

NCT04555707

Conditions

Psoriasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Apremilast 30mg

calcipotriene and betamethasone dipropionate

Study Details

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

Study ID

NCT04555707

Start date

Jun 24, 2020

Status verified date

Oct, 2020

Completion date

Sep 30, 2021

Anticipated

Primary completion date

Jun 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Otezla + Enstilar

Interventions

Apremilast 30mg

30mg PO BID started within 10 days of baseline

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.

Primary outcome measure

  • Percent of subjects who are clear or almost clear on Physicians Global Assessment at Week 4 [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

Skin Sciences, PLLC

Recruiting

Louisville, Kentucky, United States, 40217

Contacts

More Information

Sponsor

Derm Research, PLLC

Last update posted

Oct 9, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Derm Research, PLLC on 2020-10-09.