NCT00763529

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

September 29, 2008

Last Update Submit

August 13, 2024

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (4)

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

    Day 4

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

    Day 8

  • 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

  • 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 Outcomes (6)

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

    Day 15

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

    Day 22

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

    Day 29

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

    Day 15

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

    Day 22

  • +1 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Mometasone

Arm 2

ACTIVE COMPARATOR
Drug: Fluticasone

Interventions

MometasoneDRUG

Mometasone furoate cream 0.1% applied once daily

Also known as: Elocon, SCH 32088
Arm 1
FluticasoneDRUG

Fluticasone propionate cream 0.05% applied twice daily

Also known as: Cutivate
Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>=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:
  • = 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psoriasis

Interventions

Mometasone FuroateFluticasone

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAndrostadienesAndrostenesAndrostanes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2008

First Posted

October 1, 2008

Study Start

January 1, 2003

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

August 15, 2024

Record last verified: 2022-02