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The Maintenance Effect of Enstilar Foam in Combination With Otezla

Primary Purpose

Psoriasis

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Apremilast 30mg
calcipotriene and betamethasone dipropionate
Sponsored by
Derm Research, PLLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (-)UPT result at 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 > 5Y, without a uterus and/or both ovaries; or has been surgically sterile for > 6M.

    Reliable methods of contraception are:

    - hormonal methods or IUD in use > 90d prior to study drug administration, barrier methods plus spermicide in use > 14d prior, or vasectomized partner.

    [Exception: Female subjects of 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 counseled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.]

  2. Subjects with moderate plaque type psoriasis who have been started on commercial Otezla within the last 10 days
  3. Physician Global Assessment (PGA) score of 3
  4. 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 hypercalcemia or Vitamin D toxicity or history of significant renal or hepatic disease
  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. Skin conditions (e.g. eczema) that may interfere with evaluations of psoriasis
  6. Known hypersensitivity to Enstilar Foam or any of its components
  7. Current drug or alcohol abuse (Investigator opinion.)
  8. Subject unable to commit to all the assessments required by the protocol
  9. Current enrollment in another clinical study and treatment with another experimental drug or approved therapy for experimental use within 30 days prior to the Screening Visit.

Sites / Locations

  • Skin Sciences, PLLCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Otezla + Enstilar

Arm Description

Outcomes

Primary Outcome Measures

Percent of subjects who are clear or almost clear on Physicians Global Assessment at Week 4
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate

Secondary Outcome Measures

Percent of subjects who are clear or almost clear at week 4, 16 and week 20 on Physicians Global Assessment
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
The percent of subjects who are clear or almost clear at week 4, 16 and week 20 on Patient Global Assessment
Patient's Global Assessment of Disease Severity. 0=Clear, 1=Very mild, 2=Mild, 3=Moderate, 4=Severe
Percent of subjects who achieve PASI (psoriasis area and severity index) 75 at week 4
The Psoriasis Area and Severity Index (PASI) is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. PASI 75 evaluates if the subject had a 75% or more reduction in their PASI score from baseline.
Percent of subjects who achieve PASI 75 at week 16
The Psoriasis Area and Severity Index (PASI) is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. PASI 75 evaluates if the subject had a 75% or more reduction in their PASI score from baseline.
DLQI (dermatology life quality index) at week 4
The Dermatology Life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question is scored on a four-point Likert scale: Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0, Question unanswered = 0. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
DLQI at week 16
The Dermatology Life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question is scored on a four-point Likert scale: Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0, Question unanswered = 0. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Itch VAS (visual analogue scale) at week 4 and week 16
The VAS is a scale consisting of a 10cm long line and a single question used for measuring itch intensity. The left end point represents "no itch" and the right end point the "worst imaginable itch".

Full Information

First Posted
September 14, 2020
Last Updated
October 7, 2020
Sponsor
Derm Research, PLLC
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1. Study Identification

Unique Protocol Identification Number
NCT04555707
Brief Title
The Maintenance Effect of Enstilar Foam in Combination With Otezla
Official Title
The Maintenance Effect of Enstilar Foam in Combination With Otezla
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 24, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Derm Research, PLLC

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a single-center, open-label study. Approximately 30 qualified subjects will be enrolled in a study lasting 20 weeks which investigates the effect of Enstilar used in combination with Otezla to treat psoriasis.
Detailed Description
Approximately 30 subjects will be enrolled in a single-center, open-label study of the treatment of psoriasis. There will be a screening/baseline, week 4, week 16 and week 20 visits. Subjects will include those who have been started on commercial Otezla within the last 10 days of baseline. We will add Enstilar foam QD at baseline visit for 4 weeks. Those subjects who achieve clear or almost clear on PGA scale at week 4 will continue on maintenance dose of Enstilar twice weekly on Mondays and Thursdays QD for the next 12 weeks and they will also continue on Otezla. Subjects will continue to week 20 after stopping Enstilar at week 16..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Otezla + Enstilar
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Apremilast 30mg
Other Intervention Name(s)
Otezla
Intervention Description
30mg PO BID started within 10 days of baseline
Intervention Type
Drug
Intervention Name(s)
calcipotriene and betamethasone dipropionate
Other Intervention Name(s)
Enstilar
Intervention Description
1 application daily starting at baseline and continuing for 4 weeks; those achieving clear or almost clear PGA at week 4 will continue application twice weekly on Monday and Thursday in combination with Otezla. Enstilar application is discontinued at week 16 and study participation continues until week 20.
Primary Outcome Measure Information:
Title
Percent of subjects who are clear or almost clear on Physicians Global Assessment at Week 4
Description
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Percent of subjects who are clear or almost clear at week 4, 16 and week 20 on Physicians Global Assessment
Description
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
Time Frame
week 4, week 16, week 20
Title
The percent of subjects who are clear or almost clear at week 4, 16 and week 20 on Patient Global Assessment
Description
Patient's Global Assessment of Disease Severity. 0=Clear, 1=Very mild, 2=Mild, 3=Moderate, 4=Severe
Time Frame
week 4, week 16, week 20
Title
Percent of subjects who achieve PASI (psoriasis area and severity index) 75 at week 4
Description
The Psoriasis Area and Severity Index (PASI) is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. PASI 75 evaluates if the subject had a 75% or more reduction in their PASI score from baseline.
Time Frame
4 weeks
Title
Percent of subjects who achieve PASI 75 at week 16
Description
The Psoriasis Area and Severity Index (PASI) is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. PASI 75 evaluates if the subject had a 75% or more reduction in their PASI score from baseline.
Time Frame
16 weeks
Title
DLQI (dermatology life quality index) at week 4
Description
The Dermatology Life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question is scored on a four-point Likert scale: Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0, Question unanswered = 0. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Time Frame
4 weeks
Title
DLQI at week 16
Description
The Dermatology Life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question is scored on a four-point Likert scale: Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0, Question unanswered = 0. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Time Frame
16 weeks
Title
Itch VAS (visual analogue scale) at week 4 and week 16
Description
The VAS is a scale consisting of a 10cm long line and a single question used for measuring itch intensity. The left end point represents "no itch" and the right end point the "worst imaginable itch".
Time Frame
4 week, 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatient, male or female subjects of any race, 18 years of age or higher. Female subjects of childbearing potential must have a (-)UPT result at 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 > 5Y, without a uterus and/or both ovaries; or has been surgically sterile for > 6M. Reliable methods of contraception are: - hormonal methods or IUD in use > 90d prior to study drug administration, barrier methods plus spermicide in use > 14d prior, or vasectomized partner. [Exception: Female subjects of 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 counseled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.] Subjects with moderate plaque type psoriasis who have been started on commercial Otezla within the last 10 days Physician Global Assessment (PGA) score of 3 Able to understand study requirements and sign Informed Consent/HIPAA forms Exclusion Criteria: 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 hypercalcemia or Vitamin D toxicity or history of significant renal or hepatic disease Patients with guttate, erythrodermic, or pustular psoriasis Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator.) Skin conditions (e.g. eczema) that may interfere with evaluations of psoriasis Known hypersensitivity to Enstilar Foam or any of its components Current drug or alcohol abuse (Investigator opinion.) Subject unable to commit to all the assessments required by the protocol Current enrollment in another clinical study and treatment with another experimental drug or approved therapy for experimental use within 30 days prior to the Screening Visit.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Senen Pena Oliva
Phone
502-451-9000
Email
spdermresearch@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Leon H Kircik, MD
Phone
502-451-9000
Email
wedoderm@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L.H. Kircik, M.D.
Organizational Affiliation
Skin Sciences, PLLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skin Sciences, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Senen Pena Oliva, MSN
Phone
502-451-9000
Email
spdermresearch@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Maintenance Effect of Enstilar Foam in Combination With Otezla

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