Elocon vs Fluticasone in Localized Psoriasis (P03197)

Study Overview
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Brief Summary
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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.

Official Title
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Elocon vs Fluticasone in Localized Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Mometasone
* Drug: Fluticasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Mometasone<br>* Mometasone furoate cream 0.1% applied once daily<br>* Other names: SCH 32088;|
| Active Comparator: Arm 2<br> | Drug: Fluticasone<br>* Fluticasone propionate cream 0.05% applied twice daily<br>* Other names: Cutivate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 4. |  | Day 4 | 
| Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 8. |  | Day 8 | 
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 22. |  | Day 22 | 
| 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 15. |  | Day 15 | 
| 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 |