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

• ClinicalTrials.gov Identifier: NCT03848871
• Recruitment Status: Completed
• First Posted: February 21, 2019
• Results First Posted: August 26, 2020
• Last Update Posted: August 26, 2020
• Sponsor: Derm Research, PLLC
• Information provided by (Responsible Party): Derm Research, PLLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Plaque Psoriasis	Drug: Enstilar	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients
• Actual Study Start Date: December 12, 2017
• Actual Primary Completion Date: November 30, 2018
• Actual Study Completion Date: December 10, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Enstilar; Enstilar foam applied to affected area once daily; Other Name: calcipotriene and betamethasone dipropionate

Outcome Measures

Primary Outcome Measures :

1. Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4 [ Time Frame: screening/baseline, week 2, week 4 ]
   Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate

Secondary Outcome Measures :

1. Change in Lesion Size From Baseline to Week 2 and Week 4 [ Time Frame: screening/baseline, week 2, week 4 ]
   Size of target lesion recorded as height in cm x length in cm
2. Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4 [ Time Frame: screening/baseline, week 2, week 4 ]
   Percent of total body surface affected by psoriasis, calculated by multiplying the percent of a specified body area affected by psoriasis x the percent of total body surface area represented by the specified area (where head = 10% of total body surface, trunk = 30%, upper limbs = 20%, lower limbs = 40%)
3. Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema [ Time Frame: screening/baseline, week 2, week 4 ]
   A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 1= slightly pink, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 2=slight definite elevation above normal skin level, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion
4. Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration [ Time Frame: screening/baseline, week 2, week 4 ]
   A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 1=very slight, 2=slight definite elevation above normal skin level, 3=mild, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion
5. Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling [ Time Frame: screening/baseline, week 2, week 4 ]
   A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 2=slight definite elevation above normal skin level, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque, 8=very marked elevation with very hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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. -

Contacts and Locations

Locations

United States, Kentucky

DermResearch, PLLC

Louisville, Kentucky, United States, 40217

Sponsors and Collaborators

Derm Research, PLLC

  Study Documents (Full-Text)

Documents provided by Derm Research, PLLC:

Study Protocol and Statistical Analysis Plan  [PDF] March 20, 2018

More Information

• Responsible Party: Derm Research, PLLC
• ClinicalTrials.gov Identifier: NCT03848871
• Other Study ID Numbers: ENS-1702
• First Posted: February 21, 2019
• Results First Posted: August 26, 2020
• Last Update Posted: August 26, 2020
• Last Verified: August 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Psoriasis; Erythema Multiforme; Skin Diseases, Papulosquamous; Skin Diseases; Erythema; Skin Diseases, Vesiculobullous; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents