Elocon vs Fluticasone in Localized Psoriasis (P03197)

Psoriasis Clinical Trial

Official title:

Elocon vs Fluticasone in Localized Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763529
• Other study ID #: P03197
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2003
• Est. completion date: January 1, 2005

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: January 1, 2005
• Est. primary completion date: January 1, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Mometasone
Mometasone furoate cream 0.1% applied once daily
• Fluticasone
Fluticasone propionate cream 0.05% applied twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 4.		Day 4
Primary	Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 8.		Day 8
Primary	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
Primary	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	Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 15.		Day 15
Secondary	Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 22.		Day 22
Secondary	Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 29.		Day 29
Secondary	Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 15.		Day 15
Secondary	Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 22.		Day 22
Secondary	Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 29.		Day 29