Clinical trial NCT03848871: The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients
Official title: The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Lead sponsor: Derm Research, PLLC
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study seeks to show whether there is a benefit of prescribing Enstilar in the treatment of patients with moderate plaque type psoriasis. Subjects will receive study treatment of Enstilar foam.

Detailed description: Approximately 20 subjects from 3 sites will be enrolled in this open-label study. Subjects will receive Enstilar foam and all adverse events and concomitant medications will be recorded.

Subjects will attend a screening visit/baseline visit and those with plaque-type psoriasis and bilateral symmetric psoriatic plaques will have a target lesion identified on knees or elbows and subjects will receive study treatment as outlined above.

Enstilar will be initiated daily for the entire study period of four weeks. Study visits will occur as follows: screening/baseline, week 2, week 4. Study assessments at each visit will be Body Surface Area (BSA,) Physicians Global Assessment (PGA,) Target lesion size, Total Lesion Severity Score (TLSS) and standard medical assessments. There will be standard medication/treatment and washout periods.

NOTE: The original study protocol dated december 20, 2017, was designed to compare the effect of Enstilar versus vehicle for the treatment of plaque psoriasis at a 1:1 ratio. A protocol amendment on March 20, 2018 eliminated the chance of placebo and made this an open-label study of the effects of Enstilar for the treatment of plaque psoriasis.

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 (-) urine pregnancy test (UPT) result 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, without a uterus and/or both ovaries, or has been surgically sterile for \>6 months

   Reliable methods of contraception are:

   - hormonal methods or intrauterine device (IUD) in use \> 90 days prior to study drug administration, barrier methods plus spermicide in use \> 14 days prior, or vasectomized partner.

   \[Exception: Female subjects of child bearing potential (CBP) who are not sexually active are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided they are counselled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.\]
2. Moderate plaque type psoriasis eligible for topical therapies.
3. Patients with a minimum of 3% BSA to a maximum of 20% BSA \& bilateral symmetric psoriatic plaques of 2 to 4 cm in diameter.
4. Physician Global Assessment (PGA) score of 3.
5. 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 hypercalcaemia or vitamin D toxicity.
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. Topical steroids, topical immunomodulators, topical vitamin D derivatives, tar, salicylic acid, anthralin or any other topical treatment for psoriasis within 2 weeks of baseline.
6. Use of any biologics within 3 months of baseline.
7. Use of other systemic psoriasis treatments (ie, oral retinoids, methotrexate, cyclosporine, or other immunomodulators) within 4 weeks of baseline.
8. Use of ultraviolet B rays (UVB) or psoralen+ultraviolet a rays (PUVA) within 2 weeks of baseline.
9. Skin conditions (e.g. eczema) other than psoriasis that may interfere with evaluations of psoriasis.
10. Known hypersensitivity to Enstilar or any of its components.
11. Contraindications according to Enstilar.
12. Current drug or alcohol abuse (Investigator opinion.)
13. Subject unable to commit to all the assessments required by protocol. -

Primary outcomes:
measure: Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
timeFrame: screening/baseline, week 2, week 4
Secondary outcomes:
measure: Change in Lesion Size From Baseline to Week 2 and Week 4
timeFrame: screening/baseline, week 2, week 4
measure: Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4
timeFrame: screening/baseline, week 2, week 4
measure: Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
timeFrame: screening/baseline, week 2, week 4
measure: Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
timeFrame: screening/baseline, week 2, week 4
measure: Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
timeFrame: screening/baseline, week 2, week 4
Other outcomes:
Locations:
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
Study officials:
References: