The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/23/2019 |
Start Date: | December 12, 2017 |
End Date: | December 10, 2018 |
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.
of patients with moderate plaque type psoriasis. Subjects will receive study treatment of
Enstilar foam.
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.
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.
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. -
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