Recruiting

Apremilast & Clobetasol

Sponsor:

Washington Dermatology Center

Code:

NCT03453190

Conditions

Psoriasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Apremilast and Clobetasol

Study Details

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.

Conditions

Psoriasis

Study ID

NCT03453190

Start date

Feb 25, 2018

Status verified date

Feb, 2018

Completion date

Jun 30, 2020

Anticipated

Primary completion date

Mar 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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%.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: 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.

Interventions

Apremilast and Clobetasol

Patients will receive apremilast and clobetasol with tapering dosages over 16 weeks.

Primary outcome measure

  • Psoriasis Area Severity Index (PASI) [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Locations

Washington Dermatology Center

Recruiting

Rockville, Maryland, United States, 20852

Contacts

Principal Investigator:

Ronald Prussick, MD

More Information

Sponsor

Washington Dermatology Center

Last update posted

Mar 5, 2018

Last verified

Feb, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Washington Dermatology Center on 2018-03-05.