Clinical trial NCT04555707: The Maintenance Effect of Enstilar Foam in Combination With Otezla
Official title: The Maintenance Effect of Enstilar Foam in Combination With Otezla
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Derm Research, PLLC
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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..

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.

Primary outcomes:
measure: Percent of subjects who are clear or almost clear on Physicians Global Assessment at Week 4
timeFrame: 4 weeks
Secondary outcomes:
measure: Percent of subjects who are clear or almost clear at week 4, 16 and week 20 on Physicians Global Assessment
timeFrame: week 4, week 16, week 20
measure: The percent of subjects who are clear or almost clear at week 4, 16 and week 20 on Patient Global Assessment
timeFrame: week 4, week 16, week 20
measure: Percent of subjects who achieve PASI (psoriasis area and severity index) 75 at week 4
timeFrame: 4 weeks
measure: Percent of subjects who achieve PASI 75 at week 16
timeFrame: 16 weeks
measure: DLQI (dermatology life quality index) at week 4
timeFrame: 4 weeks
measure: DLQI at week 16
timeFrame: 16 weeks
measure: Itch VAS (visual analogue scale) at week 4 and week 16
timeFrame: 4 week, 16 weeks
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Skin Sciences, PLLC
state: Kentucky
Study officials:
affiliation: Skin Sciences, PLLC
name: L.H. Kircik, M.D.
role: PRINCIPAL_INVESTIGATOR
References: