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CompletedNCT01205880Updated Sep 21, 2010

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

A Phase 4 interventional study of Calcitriol ointment and Clobetasol spray in Psoriasis, sponsored by Emer, Jason, M.D.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-09-21.

Sponsored by Emer, Jason, M.D. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Psoriasis

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Keywords

  • combination treatment
  • topical corticosteroid
  • vitamin D analogue
  • clobex
  • vectical
  • clobetasol
  • calcitriol
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 12 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Emer, Jason, M.D. is the lead sponsor of 2 studies on the registry; none are open to participants now.

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
Yes

Inclusion criteria

  1. Subjects must be at least 18 years of age and in good general health as confirmed by a medical history.
  2. 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}).
  3. 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).
  4. 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).
  5. Subjects must be able to understand the requirements of the study abide by the restrictions and return for the required examinations.

Exclusion criteria

Exclusion Criteria:

  1. Female subjects who are pregnant, nursing or planning a pregnancy during the study.
  2. Subjects with known hypersensitivity to any components of the test medication.
  3. Subjects with non-plaque psoriasis (e.g. guttate, erythrodermic) or other related diseases not classified as plaque psoriasis.
  4. Subjects whose psoriasis involves only the scalp, face, groin, axillae, and/or other intertriginous areas.
  5. 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.
  6. 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.
  7. Subjects using biologics or any other systemic treatment (e.g. immunosuppressants, acitretin) for psoriasis within 12 weeks of entering the study.
  8. Subjects using systemic corticosteroids within 28 days of entering the study
  9. Subjects using topical corticosteroids or other topical therapies (other than emollients) at the target area locations within 2 weeks of entering the study
  10. Subjects using phototherapy (UVB, PUVA) within 4 weeks of entering the study.
  11. Subjects with overt pre-existing telangiectasias or skin atrophy at intended treatment sites (target areas).
  12. 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).
  13. Subjects who have participated in another investigational drug or device research study (at the target areas) within 30 days of enrollment.
  14. 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Masking
Single (Investigator)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    vectical ointment and clobex spray

    patients 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.

    Drug: Calcitriol ointment · Drug: Clobetasol spray

Interventions

  • DrugCalcitriol ointment

    twice daily

    Also known as: Vectical Ointment

  • DrugClobetasol spray

    twice daily

    Also known as: Clobex spray

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What researchers measure

Primary outcomes

  1. improvement in target lesion severity score (TLSS)

    Time frame: 4 weeks

07

Study locations

1 site
  • Mount Sinai School of Medicine
    New York, New York 10029, United States
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2010, 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
NCT01205880
Lead sponsor
Emer, Jason, M.D.
Collaborators
Galderma Laboratories
First posted
Sep 21, 2010
Start date
Dec 2009
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Sep 21, 2010

Study contacts

Jason J Emer, MD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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