Psoriasis
Conditions
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.
Interventions
DRUGMometasone
Mometasone furoate cream 0.1% applied once daily
DRUGFluticasone
Fluticasone propionate cream 0.05% applied twice daily
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 22. | Day 22 |
| Reduction in mean symptom scores for erythema, induration, pruritus, and scaling 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 29. | Day 29 |
| 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 |
Outcome results
None listed