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Psoriasis

The Maintenance Effect of Enstilar Foam in Combination With Otezla

Sponsored by Derm Research, PLLC

About this trial

Last updated 5 years ago

Study ID

ENS-2001

Status

Unknown status

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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.

Locations

Location

Status

Recruiting