Clinical trial NCT00763529: Elocon vs Fluticasone in Localized Psoriasis (P03197)
Official title: Elocon vs Fluticasone in Localized Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-10-01
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 4.
timeFrame: Day 4
measure: Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 8.
timeFrame: Day 8
measure: 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.
timeFrame: Day 4
measure: 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.
timeFrame: Day 8
Secondary outcomes:
measure: Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 15.
timeFrame: Day 15
measure: Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 22.
timeFrame: Day 22
measure: Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 29.
timeFrame: Day 29
measure: Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 15.
timeFrame: Day 15
measure: Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 22.
timeFrame: Day 22
measure: Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 29.
timeFrame: Day 29
Other outcomes:
Locations:
Study officials:
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