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

• ClinicalTrials.gov Identifier: NCT01323673
• Recruitment Status: Completed
• First Posted: March 25, 2011
• Results First Posted: December 21, 2011
• Last Update Posted: June 20, 2018
• Sponsor: Stiefel, a GSK Company
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline ( Stiefel, a GSK Company )

Study Description

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.

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

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 125 participants
• 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.
• Study Start Date: November 15, 2010
• Actual Primary Completion Date: March 1, 2011
• Actual Study Completion Date: March 29, 2011

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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 [ 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 :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• 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

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:

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

Study Data/Documents: Dataset Specification 

Identifier: 115054
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 115054
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 115054
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 115054
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 115054
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 115054
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

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):

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.

• Responsible Party: Stiefel, a GSK Company
• ClinicalTrials.gov Identifier: NCT01323673
• Other Study ID Numbers: 115054
• First Posted: March 25, 2011
• Results First Posted: December 21, 2011
• Last Update Posted: June 20, 2018
• Last Verified: June 2018

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; Clobetasol; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs