Back to resultsElocon vs Fluticasone in Localized Psoriasis (P03197)
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Mometasone
Fluticasone
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 4.
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on 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.
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.
Secondary Outcome Measures
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 15.
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 22.
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 29.
Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 15.
Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 22.
Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 29.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00763529
Brief Title
Elocon vs Fluticasone in Localized Psoriasis (P03197)
Official Title
Elocon vs Fluticasone in Localized Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2003 (Actual)
Primary Completion Date
January 1, 2005 (Actual)
Study Completion Date
January 1, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
245 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Mometasone
Other Intervention Name(s)
Elocon, SCH 32088
Intervention Description
Mometasone furoate cream 0.1% applied once daily
Intervention Type
Drug
Intervention Name(s)
Fluticasone
Other Intervention Name(s)
Cutivate
Intervention Description
Fluticasone propionate cream 0.05% applied twice daily
Primary Outcome Measure Information:
Title
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 4.
Time Frame
Day 4
Title
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 8.
Time Frame
Day 8
Title
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
Title
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 Measure Information:
Title
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 15.
Time Frame
Day 15
Title
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 22.
Time Frame
Day 22
Title
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 29.
Time Frame
Day 29
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Elocon vs Fluticasone in Localized Psoriasis (P03197)
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