Elocon vs Fluticasone in Localized Psoriasis (P03197)(COMPLETED) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00763529

Purpose

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.

Condition	Intervention	Phase
Psoriasis	Drug: Mometasone Drug: Fluticasone	Phase IV

MedlinePlus related topics: Psoriasis

Drug Information available for: Fluticasone Fluticasone propionate Mometasone furoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Elocon vs Fluticasone in Localized Psoriasis

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Reduction in mean symptom scores for erythema, induration, pruritius, and scaling on Day 4. [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
Reduction in mean symptom scores for erythema, induration, pruritius, and scaling on Day 8. [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 15. [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 22. [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 29. [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 15. [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 22. [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 29. [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

Enrollment:	245
Study Start Date:	January 2003
Study Completion Date:	January 2005
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Mometasone Mometasone furoate cream 0.1% applied once daily
Arm 2: Active Comparator	Drug: Fluticasone Fluticasone propionate cream 0.05% applied twice daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

= 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

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P03197
Study First Received:	September 29, 2008
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00763529
Health Authority:	India: NIL

Study placed in the following topic categories:

Skin Diseases
Psoriasis
Mometasone furoate
Fluticasone
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Autonomic Agents
Therapeutic Uses
Physiological Effects of Drugs
Anti-Asthmatic Agents

Peripheral Nervous System Agents
Anti-Allergic Agents
Dermatologic Agents
Bronchodilator Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009