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

NCT01323673 | Completed Phase 4 Results

• 1 other identifier: 115054
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to determine how clobetasol proprionate foam works against a placebo foam in the treatment of hand dermatitis.

Conditions

Dermatitis, Chronic

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Baseline (Day 1) and Day 15

Secondary Outcomes (7)

• Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15

  Baseline (Day 1) and Day 15

• 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

  Baseline (Day 1), Day 3, and Day 8

• 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

  Baseline (Day 1), Day 3, and Day 8

• Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15

  Days 3, 8, and 15

• 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

  Baseline (Day 1) and Days 3, 8, and 15

Study Arms (2)

Clobetasol Propionate 0.05%

ACTIVE COMPARATOR

Drug: clobetasol propionate 0.05%

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle / Placebo

Interventions

clobetasol propionate 0.05% DRUG

2 times a day, 14 total days study treatment

Clobetasol Propionate 0.05%

Vehicle / Placebo DRUG

2 times a day, 14 total days of study treatment

Vehicle

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:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (10)

GSK Investigational Site

San Diego, California, 92123, United States

Location

GSK Investigational Site

Boynton Beach, Florida, 33437, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33401, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40202, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40217, United States

Location

GSK Investigational Site

Belleville, New Jersey, 07109, United States

Location

GSK Investigational Site

Montclair, New Jersey, 07042, United States

Location

GSK Investigational Site

Knoxville, Tennessee, 37922, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37215, United States

Location

GSK Investigational Site

Austin, Texas, 78759, United States

Location

Related Publications (1)

• Kircik LH, Eastman WJ, Gwazdauskas J. A randomized, double-blind phase 4 study of the efficacy and safety of ethanol-free clobetasol propionate foam, 0.05%, vs vehicle foam in the treatment of chronic hand dermatitis. J Drugs Dermatol. 2013 Mar;12(3):328-34.

  PMID: 23545917 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Dermatitis; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 25, 2011
• Study Start: November 15, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 29, 2011
• Last Updated: June 20, 2018
• Results First Posted: December 21, 2011

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

US (10)