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Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis.

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT01323673
First received: March 24, 2011
Last updated: November 29, 2016
Last verified: November 2016
  Purpose
The purpose of this study is to determine how clobetasol proprionate foam works against a placebo foam in the treatment of hand dermatitis.

Condition Intervention Phase
Dermatitis, Chronic Drug: clobetasol propionate 0.05% Drug: Vehicle / Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline ( Stiefel, a GSK Company ):

Primary Outcome Measures:
  • Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) (Target Hand) Score From Baseline to Day 15 [ Time Frame: Baseline (Day 1) and Day 15 ]
    The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.


Secondary Outcome Measures:
  • Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15 [ Time Frame: Baseline (Day 1) and Day 15 ]
    The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.

  • Number of Participants With an Improvement of at Least 2 Grades in the ISGA (Target Hand) Score From Baseline to Day 3 and to Day 8 [ Time Frame: Baseline (Day 1), Day 3, and Day 8 ]
    The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.

  • Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 3 and and to Day 8 [ Time Frame: Baseline (Day 1), Day 3, and Day 8 ]
    The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.

  • Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 [ Time Frame: Days 3, 8, and 15 ]
    The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.

  • Number of Participants With an Improvement of at Least 1 Grade in the Subject Global Assessment (SGA) (Target Hand) Score From Baseline to Days 3, 8, and 15 [ Time Frame: Baseline (Day 1) and Days 3, 8, and 15 ]
    On Days 1, 3, 8, and 15 prior to the investigator assessment, participants rated chronic hand dermatitis of the target hand using the 5-point SGA: 0=skin is clear; 1=dermatitis in minimal, there may be a few light-pink areas; 2=dermatitis is mild, there may be occasional light-pink areas; 3=dermatitis is moderate, there may be easily noticeable pink-red areas; 4=dermatitis is severe, there may be deep or bright-red areas that may be warm to the touch.

  • Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 [ Time Frame: Days 3, 8, and 15 ]
    On Days 1, 3, 8, and 15 prior to the investigator assessment, participants rated chronic hand dermatitis of the target hand using the 5-point SGA: 0=skin is clear; 1=dermatitis in minimal, there may be a few light-pink areas; 2=dermatitis is mild, there may be occasional light-pink areas; 3=dermatitis is moderate, there may be easily noticeable pink-red areas; 4=dermatitis is severe, there may be deep or bright-red areas that may be warm to the touch.

  • Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 [ Time Frame: Baseline (Day 1) and Days 3, 8, and 15 ]
    On Days 1, 3, 8, and 15, participants assessed the pruritis (itching), stinging (piercing pain), burning, and pain of the target hand. Participants were instructed to assess the level/severity of the indicated symptoms over the previous 24 hours using a scale ranging from 0 (none) to 10 (unbearable). Percent change from baseline was calculated as value at Days 3, 8, and 15 minus the value at Baseline divided by the Baseline value * 100.


Enrollment: 125
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clobetasol Propionate 0.05% Drug: clobetasol propionate 0.05%
2 times a day, 14 total days study treatment
Placebo Comparator: Vehicle Drug: Vehicle / Placebo
2 times a day, 14 total days of study treatment

Detailed Description:
Topical corticosteroids have anti-inflammatory, immunosuppressive and antiproliferative properties. Clobetasol propionate foam 0.05% (Olux-E), a Class 1 corticosteroid, is formulated in an ethanol free petrolatum base that provides the benefits of a super-potent corticosteroid combined with moisturizing ingredients in the treatment of corticosteroid responsive dermatoses. The current study is designed to show efficacy and safety in the treatment of moderate to severe chronic hand dermatitis.
  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Capable of understanding and willing to provide signed informed consent
  • Male or female at least 12 years of age at time of consent and at time of first dose.
  • Able to complete the study and to comply with study instructions.
  • Moderate to severe hand dermatitis.
  • Chronic hand dermatitis diagnosis must be at least 6 months

Exclusion Criteria:

  • Female who is pregnant, trying to become pregnant, or breast feeding.
  • Currently diagnosed with allergic contact dermatitis.
  • Participated in a previous study of the same study product.
  • Had any major illness within 30 days before the screening/baseline visit.
  • Considered immunocompromised.
  • Has a clinically relevant history of or current evidence of abuse of alcohol or other drugs.
  • Considered unable or unlikely to attend the necessary visits.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323673

Locations
United States, California
GSK Investigational Site
San Diego, California, United States, 92123
United States, Florida
GSK Investigational Site
Boynton Beach, Florida, United States, 33437
GSK Investigational Site
West Palm Beach, Florida, United States, 33401
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40202
GSK Investigational Site
Louisville, Kentucky, United States, 40217
United States, New Jersey
GSK Investigational Site
Belleville, New Jersey, United States, 07109
GSK Investigational Site
Montclair, New Jersey, United States, 07042
United States, Tennessee
GSK Investigational Site
Knoxville, Tennessee, United States, 37922
GSK Investigational Site
Nashville, Tennessee, United States, 37215
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78759
Sponsors and Collaborators
Stiefel, a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 115054
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 115054
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 115054
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 115054
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 115054
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 115054
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 115054
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stiefel, a GSK Company
ClinicalTrials.gov Identifier: NCT01323673     History of Changes
Other Study ID Numbers: 115054
Study First Received: March 24, 2011
Results First Received: November 17, 2011
Last Updated: November 29, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Additional relevant MeSH terms:
Dermatitis
Skin Diseases
Ethanol
Clobetasol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 19, 2017