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Elocon vs Fluticasone in Localized Psoriasis (P03197)

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT00763529
Collaborator
(none)
245
Enrollment
2
Arms
24
Actual Duration (Months)

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
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 :
Jan 1, 2003
Actual Primary Completion Date :
Jan 1, 2005
Actual Study Completion Date :
Jan 1, 2005

Arms and Interventions

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 Names:
  • Cutivate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 4. [Day 4]

    2. Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 8. [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. [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. [Day 8]

    Secondary Outcome Measures

    1. Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 15. [Day 15]

    2. Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 22. [Day 22]

    3. Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 29. [Day 29]

    4. Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 15. [Day 15]

    5. Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 22. [Day 22]

    6. Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 29. [Day 29]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT00763529
    Other Study ID Numbers:
    • P03197
    First Posted:
    Oct 1, 2008
    Last Update Posted:
    Feb 17, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Psoriasis
    Fluticasone
    Mometasone Furoate

    Study Results

    No Results Posted as of Feb 17, 2022