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Apremilast in Combination With Clobetasol Spray for the Treatment of Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT03453190
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ronald Prussick, Washington Dermatology Center

Brief Summary:
Researchers want to find out if giving the drug Apremilast in combination with Clobetasol spray can help people clear their moderate to severe plaque psoriasis quicker than if Apremilast is used by itself.

Condition or disease Intervention/treatment Phase
Psoriasis Combination Product: Apremilast and Clobetasol Phase 4

Detailed Description:
People over age 18 with moderate to severe plaque psoriasis who choose to be in the study and pass the four week screening period will visit the study center about 8 times over about 16 weeks. All participants will be given Apremilast, a pill that you take in the morning and at night, and which studies have shown may reduce inflammation and improve psoriasis symptoms. All participants will also be given Clobetasol to spray twice daily for two weeks, then once daily for two weeks, then every other day for two weeks. All drugs and study visits are at no cost to participants.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Apremilast in Combination With Clobetasol Spray for the Treatment of Plaque Psoriasis
Actual Study Start Date : February 25, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Psoriasis Patients on Comb. Treatment
Patients will be given Apremilast 30 mg bid and Clobetasol Spray 0.05 % bid on a tapering schedule over 16 weeks.
Combination Product: Apremilast and Clobetasol
Patients will receive apremilast and clobetasol with tapering dosages over 16 weeks.




Primary Outcome Measures :
  1. Psoriasis Area Severity Index (PASI) [ Time Frame: 16 weeks ]
    PASI is a measure of psoriatic disease severity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be in general good health (except for disease under study) as judged by the Sponsor Investigator, based on medical history, and physical examination. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
  2. Females of childbearing potential (FCBP)† must have a negative pregnancy test at Screening and Baseline.

    Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom not made out of natural [animal] membrane [for example, polyurethane]; plus one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide

  3. Plaque psoriasis with at least 10% body surface area (BSA) involving the body with or without scalp lesions in adults aged 18 years and older.

Exclusion Criteria:

  1. Other than disease under study, any clinically significant (as determined by the Sponsor Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
  2. Any condition which would place the subject at unacceptable risk if he/she were to participate in the study.
  3. Prior history of suicide attempt at any time in the subject's life time prior to screening or baseline, or major psychiatric illness requiring hospitalization within the last 3 years.
  4. Pregnant or breast feeding.
  5. Active substance abuse or a history of substance abuse within 6 months prior to Screening.
  6. Malignancy or history of malignancy, except for:

    1. treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
    2. treated [ie, cured] cervical intraepithelial neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years.
  7. Use of any investigational drug within 4 weeks prior to baseline, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
  8. Prior treatment with apremilast.
  9. Concomitant use of drugs that treat psoriasis including but not limited to methotrexate, acitretin, cyclosporine within 4 weeks of baseline.
  10. Adalimumab, etanercept, efalizumab, infliximab, or certolizumab pegol within 12 weeks prior to baseline.
  11. Alefacept, briakinumab, ixekizumab, brodalumab or ustekinumab within 24 weeks prior to baseline.
  12. Use of phototherapy within 4 weeks prior to baseline
  13. Plaque-type psoriasis with BSA<10%
  14. Psoriasis predominantly involving the face or folds (groin or axilla)
  15. Psoriasis only of the palms/soles, pustular or other forms of psoriasis
  16. Concurrent skin or systemic infection
  17. History of intolerance to topical steroids or apremilast.
  18. Topical therapy within 2 weeks of baseline (including but not limited to topical corticosteroids, topical retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol). Exceptions: Clobetasol Spray 0.05%.

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): NCT03453190


Contacts
Contact: Ronald Prussick, MD 3019843000 drprussick@aol.com
Contact: Vicki Smith 3019843000 wdcderm22@gmail.com

Locations
United States, Maryland
Washington Dermatology Center Recruiting
Rockville, Maryland, United States, 20852
Contact: Vicki Smith    301-984-3000    wdcderm22@gmail.com   
Contact: Ronald Prussick, M.D.    3019843000    drprussick@aol.com   
Principal Investigator: Ronald Prussick, MD         
Sponsors and Collaborators
Washington Dermatology Center
  Study Documents (Full-Text)

Documents provided by Ronald Prussick, Washington Dermatology Center:

Publications:
Responsible Party: Ronald Prussick, Principal Investigator, Washington Dermatology Center
ClinicalTrials.gov Identifier: NCT03453190     History of Changes
Other Study ID Numbers: WIRB1180837
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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.: Yes

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Clobetasol
Thalidomide
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
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists