Elocon vs Fluticasone in Localized Psoriasis (P03197)
- Registration Number
- NCT00763529
- Lead Sponsor
- Organon and Co
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 245
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
- = slight
- = moderate
- = 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Mometasone - Arm 2 Fluticasone -
- Primary Outcome Measures
Name Time Method 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. Day 8 Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 4. Day 4 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. Day 4 Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 8. Day 8
- Secondary Outcome Measures
Name Time Method Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 15. Day 15 Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 29. Day 29 Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 22. Day 22 Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 29. Day 29 Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 22. Day 22 Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 15. Day 15