The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients

NCT ID: NCT03848871

Last Updated: 2020-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-12
• Study Completion Date: 2018-12-10

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.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enstilar foam

Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4.

Group Type: EXPERIMENTAL

Enstilar

Intervention Type: DRUG

Enstilar foam applied to affected area once daily

Interventions

Enstilar

Enstilar foam applied to affected area once daily

Intervention Type: DRUG

Other Intervention Names

calcipotriene and betamethasone dipropionate

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. -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Derm Research, PLLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

DermResearch, PLLC

Louisville, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ENS-1702

Identifier Type: -

Identifier Source: org_study_id