Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam

NCT00842153 | Completed Phase 4 Results

• 1 other identifier: OEF0701
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis.

Conditions

Psoriasis

Keywords

Psoriasis; Plaque Type Psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4

  The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.

  Weeks 1, 2, and 4

Secondary Outcomes (16)

• Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4

  Weeks 1, 2, and 4

• Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2

  Week 2

• Number of Participants With an Erythema Score of 0 or 1 at Week 2

  Week 2

• Number of Participants With a Scaling Score of 0 or 1 at Week 2

  Week 2

• Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2

  Week 2

Study Arms (2)

Clobetasol Propionate Foam

EXPERIMENTAL

Topical foam formulation that includes clobetasol propionate (Steroid)

Drug: Clobetasol propionate foam

Vehicle Foam

PLACEBO COMPARATOR

Vehicle foam is the same as the clobetasol propionate foam except it does not include the active drug.

Drug: Vehicle foam

Interventions

Clobetasol propionate foam DRUG

Topical Clobetasol propionate foam

Also known as: Olux-E

Clobetasol Propionate Foam

Vehicle foam DRUG

Vehicle foam does not include the active drug.

Vehicle Foam

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient, male or female of any race, and at least 12 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
• Mild to moderate, plaque-type psoriasis
• Target lesion on the trunk or extremities (excluding palms/soles, elbows, or knees) with a score of 2 or 3 for each of erythema, scaling and plaque thickness
• Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization Forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.

You may not qualify if:

• Female subjects who are pregnant (positive urine pregnancy test) breast feeding or who are of childbearing potential and not practicing a reliable method of birth control
• Known allergy to clobetasol propionate or other topical corticosteroids; or to any component of the investigational formulations
• Subjects who have not complied with the proper wash-out periods for prohibited medications
• Medical condition that in the opinion of the investigator, contraindicates the subject's participation in the clinical study
• Skin disease/disorder that might interfere with the study related diagnosis or evaluations
• Evidence of recent alcohol or drug abuse
• History of poor cooperation, non-compliance with medical treatment or unreliability

Sponsors & Collaborators

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

Study Sites (2)

Center for Dermatology, Cosmetic and Laser

Fremont, California, 94538, United States

Location

Dermatology Specialists

Louisville, Kentucky, 40202, 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2009
• First Posted: February 12, 2009
• Study Start: November 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: January 1, 2008
• Last Updated: October 9, 2017
• Results First Posted: January 30, 2012

Record last verified: 2017-10

Locations

US (2)