Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis

NCT00988637 | Completed Phase 4 Results

• 1 other identifier: US10144
• Study Type: interventional
• Target: 138
• Locations: 2 countries
• Sites: 6

Brief Summary

This clinical trial will evaluate the efficacy and safety of Clobex® (clobetasol propionate) Spray 0.05% and Vectical™ (calcitriol) Ointment 3 µg/g over a four week period of use in one of two different regimens:

1. 1.Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray treatment twice daily on weekends (Sat - Sun) for 28 days
2. 2.Clobex® Spray once each morning and Vectical™ Ointment once each evening for 28 days

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 4 Based on the Overall Disease Severity (ODS), Full Ordinal Scale From Baseline to Week 4

  Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at week 4 based on the Overall Disease Severity (ODS), full ordinal scale from baseline to week 4. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.

  Baseline to Week 4

Secondary Outcomes (12)

• Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 Based on the Overall Disease Severity (ODS), Dichotomized Scale From Baseline to Week 2

  Baseline to week 2

• Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4

  Baseline to Week 4

• Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4

  Baseline to Week 4

• Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4

  Baseline to Week 4

• Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4

  Baseline to Week 4

Study Arms (2)

1) Vectical™ Ointment and Clobex® Spray

OTHER

Vectical™ Ointment weekdays \& Clobex® Spray weekends regimen

Drug: Vectical™ Ointment weekdays and Clobex® Spray weekends regimen

2) Clobex® Spray and Vectical™ Ointment

OTHER

Clobex® Spray morning and Vectical™ Ointment evening regimen

Drug: Clobex® Spray morning and Vectical™ Ointment evening regimen

Interventions

Vectical™ Ointment weekdays and Clobex® Spray weekends regimen DRUG

Vectical™ Ointment 3 µg/g, topical, apply twice daily on weekdays (Mon-Fri) and Clobex® Spray 0.05% twice daily on weekends (Sat-Sun) for 28 days

Also known as: calcitriol ointment 3µg/g and clobetasol propionate spray 0.05%

1) Vectical™ Ointment and Clobex® Spray

Clobex® Spray morning and Vectical™ Ointment evening regimen DRUG

Clobex® Spray 0.05%, topical, apply once each morning and Vectical™ Ointment 3 µg/g, topical, apply once each evening for 28 days

Also known as: clobetasol propionate spray 0.05% and calcitriol ointment 3 µg/g

2) Clobex® Spray and Vectical™ Ointment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 18 to 80 years inclusive
• Subjects with an Overall Disease Severity of 3 (moderate)
• Subjects with 3% - 10% treatable BSA (Body Surface Area) excluding scalp, face, groin, axillae and/or other intertriginous areas
• For concurrent medications, type and dose must have been stable for at least 3 months prior to study entry and not expected to change during the study. Subjects receiving treatment with beta-blockers or lithium, whose dose has been stable for at lest 6 months and who have shown no worsening of their psoriasis, may be included in the study, at the discretion of the investigator

You may not qualify if:

• 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
• Subjects whose psoriasis involves only the scalp, face, groin, axillae, and/or other intertriginous areas
• Subjects with a wash-out period for topical treatment less than 30 days (Any steroid containing medication, dovonex, anthralin, tar and/or UVB treatment)
• Subjects with a wash-out period for systemic treatment less than 12 weeks (corticosteroids, biologics and/or PUVA treatment; Examples of these therapies include, but are not limited to PUVA, Soriatane, Cyclosporine, Hydroxyurea, Mycophenolate mofetil, Sulfasalazine, Azathioprine, Alefacept, Efalizumab, Adalimumab, Etanercept, Infliximab, Rituximab, and Methotrexate)
• Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis
• Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (6)

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Hudson Dermatology

Evansville, Indiana, 47714, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Baylor Research Institute Dermatology Research

Dallas, Texas, 75246, United States

Location

Probity Medical Research

Waterloo, Ontario, N2J1C4, Canada

Location

Related Publications (2)

• Hudson CP, Kempers S, Menter A, Papp K, Smith S, Sofen H, Colon LE, Johnson LA, Gottschalk R. An open-label, multicenter study of the efficacy and safety of a weekday/weekend treatment regimen with calcitriol ointment 3 microg/g and clobetasol propionate spray 0.05% in the management of plaque psoriasis. Cutis. 2011 Oct;88(4):201-7.

  PMID: 22106730 DERIVED

• Menter A, Sofen H, Smith S, Papp K, Kempers S, Hudson CP, Colon LE, Johnson LA, Gottschalk R. An open-label, multicenter study of the efficacy and safety of an AM/PM treatment regimen with clobetasol propionate spray 0.05% and calcitriol ointment 3 microg/g in the management of plaque psoriasis. Cutis. 2011 Jul;88(1):46-51.

  PMID: 21877508 DERIVED

Results Point of Contact

• Title: Ronald W. Gottschalk, MD / Medical Dierctor
• Organization: Galderma Laboratories, L.P.

ron.gottschalk@galderma.com

817-961-5358

Study Officials

• Ronald W Gottschalk, MD

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: October 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 1, 2022
• Results First Posted: June 3, 2011

Record last verified: 2012-09

Locations

CA (1); US (5)