ClinicalTrials.gg
Status unknownNCT03453190Updated Mar 5, 2018

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

A Phase 4 interventional study of Apremilast and Clobetasol in Psoriasis, sponsored by Washington Dermatology Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-05.

Sponsored by Washington Dermatology Center · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.

This study's planned enrollment of 20 is below the median of 70 across 1,472 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

This is the only study on the registry with Washington Dermatology Center as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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%.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study 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.

    Combination Product: Apremilast and Clobetasol

Interventions

  • Combination productApremilast and Clobetasol

    Drug pages: Apremilast · Clobetasol

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

06

What researchers measure

Primary outcomes

  1. Psoriasis Area Severity Index (PASI)

    PASI is a measure of psoriatic disease severity

    Time frame: 16 weeks

07

Study locations

1 of 1 sites recruiting
  • Washington Dermatology Center
    Rockville, Maryland 20852, United States
    Recruiting
08

References and documents

Publications

  • Menter A. Topical monotherapy with clobetasol propionate spray 0.05% in the COBRA trial. Cutis. 2007 Nov;80(5 Suppl):12-9. PubMed 18154219 ↗
  • Papp K, Cather JC, Rosoph L, Sofen H, Langley RG, Matheson RT, Hu C, Day RM. Efficacy of apremilast in the treatment of moderate to severe psoriasis: a randomised controlled trial. Lancet. 2012 Aug 25;380(9843):738-46. doi: 10.1016/S0140-6736(12)60642-4. Epub 2012 Jun 29. PubMed 22748702 ↗
  • Beutner K, Chakrabarty A, Lemke S, Yu K. An intra-individual randomized safety and efficacy comparison of clobetasol propionate 0.05% spray and its vehicle in the treatment of plaque psoriasis. J Drugs Dermatol. 2006 Apr;5(4):357-60. PubMed 16673804 ↗
  • Carey W, Glazer S, Gottlieb AB, Lebwohl M, Leonardi C, Menter A, Papp K, Rundle AC, Toth D. Relapse, rebound, and psoriasis adverse events: an advisory group report. J Am Acad Dermatol. 2006 Apr;54(4 Suppl 1):S171-81. doi: 10.1016/j.jaad.2005.10.029. PubMed 16488339 ↗
  • Gordon KB, Feldman SR, Koo JY, Menter A, Rolstad T, Krueger G. Definitions of measures of effect duration for psoriasis treatments. Arch Dermatol. 2005 Jan;141(1):82-4. doi: 10.1001/archderm.141.1.82. No abstract available. PubMed 15655149 ↗
  • Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839. PubMed 357213 ↗

Study documents

  • Protocol and statistical analysis plan · Oct 10, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03453190
Lead sponsor
Washington Dermatology Center
Responsible party
Ronald Prussick (Principal Investigator, Washington Dermatology Center) — Principal investigator
First posted
Mar 5, 2018
Start date
Feb 25, 2018
Primary completion
Mar 1, 2020 (estimated)
Completion
Jun 30, 2020 (estimated)
Last update
Mar 5, 2018

Study contacts

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

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Apremilast · Clobetasol

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