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

NCT01205880 | Completed Phase 4 DMC

• 1 other identifier: 08-1500
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis

Keywords

combination treatment; topical corticosteroid; vitamin D analogue; clobex; vectical; clobetasol; calcitriol

Outcome Measures

Primary Outcomes (1)

• improvement in target lesion severity score (TLSS)

  4 weeks

Study Arms (1)

vectical ointment and clobex spray

ACTIVE COMPARATOR

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

Calcitriol ointment DRUG

twice daily

Also known as: Vectical Ointment

vectical ointment and clobex spray

Clobetasol spray DRUG

twice daily

Also known as: Clobex spray

vectical ointment and clobex spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Emer, Jason, M.D.: lead
• Galderma Laboratories: collaborator

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (5)

• 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.

  PMID: 17186795 BACKGROUND

• 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.

  PMID: 16673804 BACKGROUND

• 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.

  PMID: 19217694 BACKGROUND

• 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.

  PMID: 19702032 BACKGROUND

• 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.

  PMID: 12639460 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jason J Emer, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: September 21, 2010
• Study Start: December 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: September 21, 2010

Record last verified: 2010-09

Locations

US (1)