Elocon vs Fluticasone in Localized Psoriasis (P03197)

Elocon vs Fluticasone in Localized Psoriasis

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Mometasone; Drug: Fluticasone

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1	Drug: Mometasone; Mometasone furoate cream 0.1% applied once daily; Other Names: SCH 32088; Elocon
ACTIVE_COMPARATOR: Arm 2	Drug: Fluticasone; Fluticasone propionate cream 0.05% applied twice daily; Other Names: Cutivate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 29.	Day 29

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2003
• Primary Completion (ACTUAL): January 1, 2005
• Study Completion (ACTUAL): January 1, 2005

Study Registration Dates

• First Submitted: September 29, 2008
• First Submitted That Met QC Criteria: September 29, 2008
• First Posted (ESTIMATE): October 1, 2008

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone; Mometasone Furoate
• Other Study ID Numbers: P03197

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis