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Elocon vs Fluticasone in Localized Psoriasis (P03197)

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ClinicalTrials.gov Identifier: NCT00763529
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Mometasone Drug: Fluticasone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Elocon vs Fluticasone in Localized Psoriasis
Actual Study Start Date : January 1, 2003
Actual Primary Completion Date : January 1, 2005
Actual Study Completion Date : January 1, 2005


Arm Intervention/treatment
Experimental: Arm 1 Drug: Mometasone
Mometasone furoate cream 0.1% applied once daily
Other Names:
  • Elocon
  • SCH 32088
Active Comparator: Arm 2 Drug: Fluticasone
Fluticasone propionate cream 0.05% applied twice daily
Other Name: Cutivate



Primary Outcome Measures :
  1. Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 4. [ Time Frame: Day 4 ]
  2. Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 8. [ Time Frame: Day 8 ]
  3. 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 ]
  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. [ Time Frame: Day 8 ]

Secondary Outcome Measures :
  1. Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 15. [ Time Frame: Day 15 ]
  2. Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 22. [ Time Frame: Day 22 ]
  3. Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 29. [ Time Frame: Day 29 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

  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

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00763529     History of Changes
Other Study ID Numbers: P03197
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Fluticasone
Mometasone Furoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents