Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis
Source: ClinicalTrials.gov NCT03441789 ↗No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects With a Psoriasis Assessment and Severity Index (PASI) 75 at Week 16 |
7; 2 | — |
| SECONDARY Percent of Subjects With PASI 75 at Week 4 and Week 12 |
7; 1; 4; 2 | — |
| SECONDARY Percent of Subjects With PASI 90 and 100 at Week 16 |
4; 2; 1; 0 | — |
| SECONDARY Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16 |
1; 0; 5; 1; 7; 4 | — |
| SECONDARY Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16 |
2; 5; 4; 4; 3; 4 | — |
| SECONDARY Global Percent Improvement in Dermatologic Quality of Life Index (DLQI) at Week 4, 12, and 16 |
2; 5; 5; 5; 3; 6 | — |
Eligibility Criteria
Inclusion Criteria
I. Outpatient, male or female subjects of any race, 18 years of age or higher. Female subjects of childbearing potential must have a (-)UPT (urine pregnancy test) 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 ≥ 5 years of age, without a uterus and/or both ovaries; or has been surgically sterile for ≥ 6 moths.
Reliable methods of contraception are:
- hormonal methods or IUD (intrauterine device) in use ≥ 90 days prior to study drug administration, barrier methods plus spermicide in use ≥ 14 days prior, or vasectomized partner.
[Exception: Female subjects of CBP (child bearing potential) 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.] ii. Subjects with moderate plaque type psoriasis who have been started on commercial Otezla within the last 10 days.
iii. Physician Global Assessment (PGA) score of 3. iv. Able to understand study requirements and sign Informed Consent/HIPAA forms.
Exclusion Criteria
I. 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.
ii. History of hypercalcemia or vitamin D toxicity or history of significant renal or hepatic disease iii. Patients with guttate, erythrodermic, or pustular psoriasis iv. Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator).
v. Skin conditions (e.g.eczema) other than psoriasis that may interfere with evaluations of psoriasis.
vi. Known hypersensitivity to Enstilar Foam or any of its components. vii. Current drug or alcohol abuse (Investigator opinion). viii. Subject unable to commit to all the assessments required by the protocol. ix. 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.
Data sourced from ClinicalTrials.gov (NCT03441789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.