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Completed

NCT Number: NCT00763529

Elocon vs Fluticasone in Localized Psoriasis (P03197)

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mometasone

Drug

Mometasone furoate cream 0.1% applied once daily

Other names: Elocon, SCH 32088

Fluticasone

Drug

Fluticasone propionate cream 0.05% applied twice daily

Other names: Cutivate

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Elocon vs Fluticasone in Localized Psoriasis

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Oct 1, 2008
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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