ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03441789
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Leon Kircik, M.D., Derm Research, PLLC

Brief Summary:
This study seeks to show whether there is a benefit of prescribing Enstilar with Otezla in the treatment of patients with moderate plaque type psoriasis. Subjects will be randomized to study treatment at a 1:1 ratio of Otezla plus Enstilar foam versus Otezla plus vehicle foam.

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

Detailed Description:

Approximately 50 subjects from 4 sites will be enrolled in this investigator-blind study. Subjects will be randomized 1:1 to Otezla plus Enstilar foam or Otezla plus vehicle 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 who have been started on commercial Otezla in the last 7 days will be randomized to study treatment as outlined above.

Enstilar or the vehicle will be initiated for the first 4 weeks and then Otezla will be continued as monotherapy for the next 8 weeks. Enstilar or the vehicle will be reinitiated for the last 4 weeks of the study. Total study period is 16 weeks and study visits will occur as follows: screening/baseline, week 1, 2, 3, 4, week 12, and week 16. Study assessments at each visit will be PASI, BSA, PGA, Itch VAS, DLQI, and standard medical assessments. There will be standard medication/treatment and washout periods.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast

Arm Intervention/treatment
Experimental: Otezla plus Enstilar foam
Subjects randomized to this group will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily
Drug: Enstilar
Enstilar foam applied to affected areas daily
Other Name: calcipotriene and betamethasone dipropionate

Drug: Otezla
Otezla 30mg

Placebo Comparator: Otezla plus vehicle foam
Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily
Drug: Vehicle
vehicle foam applied to affected areas once daily

Drug: Otezla
Otezla 30mg




Primary Outcome Measures :
  1. Percent of subjects with a Psoriasis Assessment and Severity Index (PASI) 75 at week 16 in Enstilar plus Otezla group versus vehicle plus Otezla group [ Time Frame: 16 weeks ]
    Percent of subjects with at least a 75% improvement in PASI by week 16


Secondary Outcome Measures :
  1. PASI 75 at week 4 and week 12 [ Time Frame: 4 weeks, 12 weeks ]
    Percent of subjects with at least a 75% improvement in PASI at week 4 and at week 12

  2. PASI 90 and 100 at week 16 [ Time Frame: 16 weeks ]
    Percent of subjects with at least 90% improvement in PASI and 100% improvement in PASI at week 16

  3. PGA at week 4 and week 12 and week 16 [ Time Frame: 4 weeks, 12 weeks, 16 weeks ]
    Percent of patients with at least a 1-grade improvement in PGA at week 4 and week 12 and week 16

  4. Itch Visual Analogue Scale (VAS) at week 4,12 and 16 [ Time Frame: 4 weeks, 12 weeks, 16 weeks ]
    Global percent improvement in Itch VAS at week 4, 12, and 16

  5. Dermatologic Quality of Life Index (DLQI) at week 4, 12, and 16 [ Time Frame: 4 weeks, 12, weeks, 16 weeks ]
    Global percent improvement in DLQI at week 4, 12, and 16



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

I. Outpatient, male or female subjects of any race, 18 years of age or higher. Female subjects of childbearing potential must have a (-)UPT (urine pregnancy test) 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 ≥ 5 years of age, without a uterus and/or both ovaries; or has been surgically sterile for ≥ 6 moths.

Reliable methods of contraception are:

- hormonal methods or IUD (intrauterine device) 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 CBP (child bearing potential) 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.] ii. Subjects with moderate plaque type psoriasis who have been started on commercial Otezla within the last 10 days.

iii. Physician Global Assessment (PGA) score of 3. iv. Able to understand study requirements and sign Informed Consent/HIPAA forms.

Exclusion Criteria:

I. 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.

ii. History of hypercalcemia or vitamin D toxicity or history of significant renal or hepatic disease iii. Patients with guttate, erythrodermic, or pustular psoriasis iv. Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator).

v. Skin conditions (e.g.eczema) other than psoriasis that may interfere with evaluations of psoriasis.

vi. Known hypersensitivity to Enstilar Foam or any of its components. vii. Current drug or alcohol abuse (Investigator opinion). viii. Subject unable to commit to all the assessments required by the protocol. ix. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441789


Contacts
Contact: CRC 502-451-9000 mmdermresearch@yahoo.com
Contact: CRC 502-451-9000 wedoderm@yahoo.com

Locations
United States, California
Center for Dermatology and Laser Surgery Recruiting
Sacramento, California, United States, 95819
Contact: CRC    916-454-5922      
United States, Kentucky
Skin Sciences, PLLC Recruiting
Louisville, Kentucky, United States, 40217
Contact: CRC    502-451-9000    mmdermresearch@yahoo.com   
Contact: CRC    502-451-9000    wedoderm@yahoo.com   
Principal Investigator: Leon H Kircik, MD         
United States, Maryland
Lawrence J. Green, MD LLC Recruiting
Rockville, Maryland, United States, 20850
Contact: CRC    301-610-0663      
United States, South Carolina
Dermatology & Laser Center of Charleston Recruiting
Charleston, South Carolina, United States, 29414
Contact: CRC    843-556-8886      
Sponsors and Collaborators
Leon Kircik, M.D.

Responsible Party: Leon Kircik, M.D., Medical Director, Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT03441789     History of Changes
Other Study ID Numbers: ENS-1701
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

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
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Calcipotriene
Thalidomide
Calcitriol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents