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PsoriasisPhase 4NCT01205880

Study to Evaluate Vectical in Combination With Clobex Spray to Treatment Plaque Psoriasis

A Phase 4 study testing Calcitriol ointment and Clobetasol spray in people with Psoriasis, run by Emer, Jason, M.D. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This investigator-blinded study is designed to assess whether the order of application affects the efficacy of the combination treatment Clobex® Spray (clobetasol propionate) and Vecitcal® (calcitriol) Ointment in plaque psoriasis. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Psoriasis
What is being tested?
Calcitriol ointment and Clobetasol spray
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Dec 2009to Jan 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects must be at least 18 years of age and in good general health as confirmed by a medical history.
  • Females of childbearing potential must have a negative urine pregnancy test on Baseline/Day 0 and must agree to use adequate birth control methods during the entire study (a barrier method {condoms, diaphragm}; hormonal contraceptives {birth control pills, implants [Norplant] or injections [DepoProvera]}; intrauterine device {IUD}; or abstinence {no sexual activity}).
  • Subjects must be diagnosed with plaque psoriasis affecting < 20% body surface area, with at least one discreet plaque on the each side of the body (excluding the face, scalp, groin, axillae or other intertriginous areas).
  • Subjects must have at least 2 lesions suitable for evaluating response to test agents (one on the right side and one on the left side of the body). The severity of the disease for each target lesion at Baseline/Day 0 must be rated at least 2 (Mild) for each of the key psoriasis characteristics (scaling, erythema, and plaque elevation).
  • Subjects must be able to understand the requirements of the study abide by the restrictions and return for the required examinations.

Who cannot join

  • Female subjects who are pregnant, nursing or planning a pregnancy during the study.
  • Subjects with known hypersensitivity to any components of the test medication.
  • Subjects with non-plaque psoriasis (e.g. guttate, erythrodermic) or other related diseases not classified as plaque psoriasis.
  • Subjects whose psoriasis involves only the scalp, face, groin, axillae, and/or other intertriginous areas.
  • Subjects who have surface area involvement too large (>20% BSA) that would require more than 59 ml/week (50 g/week) of Clobex® spray and/or more than 200 g/week of Vectical® ointment.
  • Subjects requiring any other medication (topical or systemic) that may affect the course of the disease during the study period as determined by the study investigators.
Show all 14Show fewer
  • Subjects using biologics or any other systemic treatment (e.g. immunosuppressants, acitretin) for psoriasis within 12 weeks of entering the study.
  • Subjects using systemic corticosteroids within 28 days of entering the study
  • Subjects using topical corticosteroids or other topical therapies (other than emollients) at the target area locations within 2 weeks of entering the study
  • Subjects using phototherapy (UVB, PUVA) within 4 weeks of entering the study.
  • Subjects with overt pre-existing telangiectasias or skin atrophy at intended treatment sites (target areas).
  • Subjects with intakes of more than 2,000 IU/day (50 mcg/day) of vitamin D (tolerable upper intake level) and/or more than 1,000 mg/day of calcium (based on Dietary Reference Intakes developed by the Institute of Medicine of the National Academy of Sciences).
  • Subjects who have participated in another investigational drug or device research study (at the target areas) within 30 days of enrollment.
  • Subjects who are using any medication or has any disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mount Sinai School of Medicine

    New York, New York, 10029

Other trials in United States

About this study

Official title: Spray® and Vectical Ointment® in the Treatment of Plaque Psoriasis

This investigator-blinded study is designed to assess whether the order of application affects the efficacy of the combination treatment Clobex® Spray (clobetasol propionate) and Vecitcal® (calcitriol) Ointment in plaque psoriasis.

Read the detailed description

This is an investigator-blinded, bilateral comparison study. A total of up to 12 subjects with mild to moderate plaque psoriasis will be enrolled in this study, so that at least 10 subjects complete the 4 week trial. These 12 subjects will receive the combination therapy of Clobex® Spray and Vectical® Ointment to treat their psoriatic lesions (except those on the scalp, face, groin, axillae or other intertriginous areas). Half of the subjects will first apply the Clobex® Spray followed by the Vectical ointment to lesions on the right side of their bodies, and Vectical® Ointment first followed by Clobex® Spray to the lesions of the left side of their bodies. The other half of the subjects will first apply Clobex® Spray followed by Vectical® Ointment to the lesions of the left side of their bodies, and Vectical® Ointment first followed by Clobex® Spray to the lesions on right side of their bodies. Treatment will be applied twice daily for 4 weeks. One target area on each side of the subject's body will be chosen for target lesion assessment.

All subjects will be consented prior to any study evaluations/procedures. Study evaluations including Target Lesion Severity Score (TLSS) and photography will be performed at Baseline/Day 0, week 2 and week 4.

Conditions
Psoriasis
Being tested
Calcitriol ointment, Clobetasol spray
Keywords
combination treatment, topical corticosteroid, vitamin D analogue, clobex, vectical, clobetasol, calcitriol
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Calcitriol ointmentDrug

    Also called Vectical Ointment

    twice daily

  • Clobetasol sprayDrug

    Also called Clobex spray

    twice daily

Study groups in NCT01205880
Study groupRoleWhat they receive
vectical ointment and clobex sprayActive comparatorpatients were assigned to apply vectical ointment first then clobex spray on one target lesion and also apply clobex spray first then vectical ointment on a different target lesion on the opposite side of the body.
Receives: Drug: Calcitriol ointment; Drug: Clobetasol spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. improvement in target lesion severity score (TLSS)

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionJan 2010
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Masking
Single blind
Who is masked
Investigator
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01205880
Sponsor's protocol ID
08-1500
Status last verified
Sep 2010
First submitted
17 Sep 2010
Last updated
21 Sep 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Jarratt MT, Clark SD, Savin RC, Swinyer LJ, Safley CF, Brodell RT, Yu K. Evaluation of the efficacy and safety of clobetasol propionate spray in the treatment of plaque-type psoriasis. Cutis. 2006 Nov;78(5):348-54.

    PubMed 17186795

  • 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

  • Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb A, Koo JY, Lebwohl M, Lim HW, Van Voorhees AS, Beutner KR, Bhushan R; American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009 Apr;60(4):643-59. doi: 10.1016/j.jaad.2008.12.032. Epub 2009 Feb 13.

    PubMed 19217694

  • Abramovits W. Calcitriol 3 microg/g ointment: an effective and safe addition to the armamentarium in topical psoriasis therapy. J Drugs Dermatol. 2009 Aug;8(8 Suppl):s17-22.

    PubMed 19702032

  • Bruner CR, Feldman SR, Ventrapragada M, Fleischer AB Jr. A systematic review of adverse effects associated with topical treatments for psoriasis. Dermatol Online J. 2003 Feb;9(1):2.

    PubMed 12639460

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Calcitriol ointment and Clobetasol spray in people with Psoriasis, run by Emer, Jason, M.D. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

improvement in target lesion severity score (TLSS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01205880, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2010.

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