Last updated: 11/07/2018 08:31:56
Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis.
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis.
Trial description: The purpose of this study is to determine how clobetasol proprionate foam works against a placebo foam in the treatment of hand dermatitis.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
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
Timeframe: Baseline (Day 1) and Day 15
Secondary outcomes:
Number of participants with an improvement of at least 1 grade in the ISGA (target hand) score from Baseline to Day 15
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Baseline (Day 1) and Days 3, 8, and 15
Number of participants with an SGA (target hand) score of 0 or 1 at Days 3, 8, and 15
Timeframe: Days 3, 8, and 15
Percent change from Baseline in pruritus, stinging, burning, and pain scores (target hand) at Days 3, 8, and 15
Timeframe: Baseline (Day 1) and Days 3, 8, and 15
Interventions:
Drug: clobetasol propionate 0.05%
Drug: Vehicle / Placebo
Enrollment:
125
Observational study model:
Not applicable
Primary completion date:
2011-29-03
Time perspective:
Not applicable
Clinical publications:
Leon Kircik, MD, William J Eastman, MD, Jennifer Gwazdauskas. A randomized, double-blind, phase IV study of the efficacy and safety of clobetasol propionate foam, 0.05% versus vehicle foam in the treatment of chronic hand dermatitis.. J Drugs Dermatol. 2013;12(3):328-34.
Medical condition
Dermatitis, Chronic
Product
clobetasol
Collaborators
GSK
Study date(s)
November 2010 to March 2011
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- 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.
- Female who is pregnant, trying to become pregnant, or breast feeding.
- Currently diagnosed with allergic contact dermatitis.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Boynton Beach, Florida, United States, 33437
Status
Study Complete
Location
GSK Investigational Site
Montclair, New Jersey, United States, 07042
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40217
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37215
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40202
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33401
Status
Study Complete
Location
GSK Investigational Site
Belleville, New Jersey, United States, 07109
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37922
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2011-29-03
Actual study completion date
2011-29-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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