A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis

NCT00852761 | Completed Phase 4 Results

• 2 other identifiers: 114569U0280-402
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.

Conditions

Plaque-Type Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

• At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)

  Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.

  Baseline to day 15

Secondary Outcomes (18)

• At Least 1 Grade Improvement Psoriasis Grading Scale

  Baseline, days 3 and 8

• At Least a 2 Grade Improvement Psoriasis Grading Scale

  Baseline, days 3, 8, 15

• At Least a 3 Grade Improvement Psoriasis Grading Scale

  Baseline, days 3, 8, 15

• At Least 1 Grade Improvement in the Psoriasis Global Assessment

  Baseline, days 3, 8, 15

• At Least a 2 Grade Improvement in the Psoriasis Global Assessment

  Baseline, days 3, 8, 15

Study Arms (2)

Olux-E Foam

EXPERIMENTAL

Olux-E (clobetasol propionate 0.05%) foam

Drug: Olux-E Foam

Clobex lotion

ACTIVE COMPARATOR

Clobex (clobetasol propionate 0.05%) lotion.

Drug: Clobex lotion

Interventions

Olux-E Foam DRUG

Olux-E (clobetasol propionate 0.05%) foam. Starting at baseline, subjects were to apply twice daily Olux-E foam to the affected elbows and/or knees up to day 15.

Olux-E Foam

Clobex lotion DRUG

Clobetasol propionate 0.05% lotion. Starting at baseline, subjects were to apply twice daily Clobex lotion to the affected elbows and/or knees up to day 15

Also known as: clobetasol lotion, Clobex

Clobex lotion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body surface area (BSA) affected with psoriasis between 4% and 20% .
• Target lesion of at least 2 cm² on the elbow and/or knee, with a score of 2 or 3 on the Psoriasis Grading Scale for Target Lesion.
• Elbow and/or knee plaque-type psoriasis with a Psoriasis Global Assessment of mild or moderate (2 or 3).
• Definitive diagnosis of elbow and/or knee plaque-type psoriasis.
• Capable of understanding and willing to provide a signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed.
• Male or female, 18 years of age or older at the time that the consent form was signed.
• Able to complete the study and comply with study instructions.
• Female subjects of childbearing potential must have had a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception.

You may not qualify if:

• Use of any emollient applied to psoriasis plaques treated with the study medication during the study.
• Other serious skin disorder or any chronic medical condition that is not well controlled.
• Female subjects who are pregnant, trying to become pregnant or lactating.
• Any major illness within 30 days prior to the baseline visit.
• Received any investigational drug or treatment within 30 days of the baseline visit or who are scheduled to receive an investigational drug or treatment other than the study products during the study.

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Clobetasol

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 27, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 23, 2012
• Results First Posted: October 4, 2011

Record last verified: 2012-04

Locations

US (1)