Elocon vs Fluticasone in Localized Psoriasis (P03197)

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.; Schering-Plough
• Treatments: Fluticasone; Mometasone Furoate

Criteria

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