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

NCT03848871 | Completed Phase 4 Results FDA Drug

• 1 other identifier: ENS-1702
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4

  Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate

  screening/baseline, week 2, week 4

Secondary Outcomes (5)

• Change in Lesion Size From Baseline to Week 2 and Week 4

  screening/baseline, week 2, week 4

• Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4

  screening/baseline, week 2, week 4

• Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema

  screening/baseline, week 2, week 4

• Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration

  screening/baseline, week 2, week 4

• Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling

  screening/baseline, week 2, week 4

Study Arms (1)

Enstilar foam

EXPERIMENTAL

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.

Drug: Enstilar

Interventions

Enstilar DRUG

Enstilar foam applied to affected area once daily

Also known as: calcipotriene and betamethasone dipropionate

Enstilar foam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \[Exception: Female subjects of child bearing potential (CBP) who are not sexually active are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided they are counselled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.\]
• Moderate plaque type psoriasis eligible for topical therapies.
• Patients with a minimum of 3% BSA to a maximum of 20% BSA \& bilateral symmetric psoriatic plaques of 2 to 4 cm in diameter.
• Physician Global Assessment (PGA) score of 3.
• Able to understand study requirements and sign Informed Consent/HIPAA forms.

You may not qualify if:

• 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.
• History of hypercalcaemia or vitamin D toxicity.
• Patients with guttate, erythrodermic, or pustular psoriasis
• Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator.)
• Topical steroids, topical immunomodulators, topical vitamin D derivatives, tar, salicylic acid, anthralin or any other topical treatment for psoriasis within 2 weeks of baseline.
• Use of any biologics within 3 months of baseline.
• Use of other systemic psoriasis treatments (ie, oral retinoids, methotrexate, cyclosporine, or other immunomodulators) within 4 weeks of baseline.
• Use of ultraviolet B rays (UVB) or psoralen+ultraviolet a rays (PUVA) within 2 weeks of baseline.
• Skin conditions (e.g. eczema) other than psoriasis that may interfere with evaluations of psoriasis.
• Known hypersensitivity to Enstilar or any of its components.
• Contraindications according to Enstilar.
• Current drug or alcohol abuse (Investigator opinion.)
• Subject unable to commit to all the assessments required by protocol. -

Sponsors & Collaborators

• Derm Research, PLLC: lead

Study Sites (1)

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

MeSH Terms

Interventions

betamethasone dipropionate, calcipotriol drug combination

Results Point of Contact

• Title: Maureen McAllister
• Organization: Skin Sciences, PLLC

mmdermresearch@yahoo.com

5024519000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 21, 2019
• Study Start: December 12, 2017
• Primary Completion: November 30, 2018
• Study Completion: December 10, 2018
• Last Updated: August 26, 2020
• Results First Posted: August 26, 2020

Record last verified: 2020-08

Locations

US (1)