Official Title: “Elocon vs Fluticasone in Localized Psoriasis”

This is an open-label, randomized, parallel-group clinical study. The primary objective is to assess the difference in response rate between mometasone furoate cream 0.1% (once daily) vs fluticasone propionate cream 0.05% (twice daily) by the end of Day 4 and Day 8 in the management of Indian patients with localized psoriasis.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2005

Intervention(s) in this Clinical Trial

• Drug: Mometasone
  • Mometasone furoate cream 0.1% applied once daily
• Drug: Fluticasone
  • Fluticasone propionate cream 0.05% applied twice daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Active Comparator: Arm 2

Primary Measures

• Reduction in mean symptom scores for erythema, induration, pruritius, and scaling on Day 4.
  • Time Frame: Day 4
    Safety Issue?: No
• Reduction in mean symptom scores for erythema, induration, pruritius, and scaling on Day 8.
  • Time Frame: Day 8
    Safety Issue?: No
• Clinical evaluation of the change in disease status which would be defined as improvement by Day 4 relative to their severity at entry in treated areas.
  • Time Frame: Day 4
    Safety Issue?: No
• Clinical evaluation of the change in disease status which would be defined as improvement by Day 8 relative to their severity at entry in treated areas.
  • Time Frame: Day 8
    Safety Issue?: No

Secondary Measures

• Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 15.
  • Time Frame: Day 15
    Safety Issue?: No
• Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 22.
  • Time Frame: Day 22
    Safety Issue?: No
• Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 29.
  • Time Frame: Day 29
    Safety Issue?: No
• Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 15.
  • Time Frame: Day 15
    Safety Issue?: No
• Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 22.
  • Time Frame: Day 22
    Safety Issue?: No
• Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 29.
  • Time Frame: Day 29
    Safety Issue?: No

Inclusion Criteria:

• >=18 years of age
• Written informed consent
• Having localized psoriasis (not more than 5-6 patches)
• Total size of all patches should be below 8" x 8"
• Each patient should exhibit any of the following 4 signs of dermatoses:
• erythema
• palpability
• scaling
• itching (pruritus)

Each of the above signs would be grades according to the following scale:

• 0 = none
• 1. = slight
• 2. = moderate
• 3. = severe The total Disease Severity Score (ie, the sum of the scores for each of the signs) should be at least 6 (indicative of a moderate to severe disease status)

Exclusion Criteria:

• Pregnancy or lactation
• Hypersensitivity to any of the components of the test medication
• Signs of atrophy in the target area
• Lesions on palms, soles, and scalp
• Individuals who may require medications that might affect the natural course of the disease
• Not having used systemic corticosteroids or antimetabolites or any other topical corticosteroid within 2 weeks prior to enrollment in the study
• Concomitant tuberculosis/viral infection

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Schering-Plough

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00763529

Study ID Number: P03197

ClinicalTrials.gov Identifier: NCT00763529

Health Authority: India: NIL