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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone | Drug | Mometasone furoate cream 0.1% applied once daily |
|
| 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 |
| 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 |
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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:
Each of the above signs would be grades according to the following scale:
0 = none
Exclusion Criteria:
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Fluticasone | Drug | Fluticasone propionate cream 0.05% applied twice daily |
|
|
| 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 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |