Elocon vs Fluticasone in Localized Psoriasis (P03197)

Organon

Status and phase

Completed

Phase 4

Conditions

Psoriasis

Treatments

Drug: Mometasone

Drug: Fluticasone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00763529

P03197

Details and patient eligibility

About

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.

Enrollment

245 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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