Dermatitis, Chronic
Conditions
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.
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.
Interventions
2 times a day, 14 total days study treatment
2 times a day, 14 total days of study treatment
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 | 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 ISGA (Target Hand) Score From Baseline to Day 15 | 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 SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 | 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 | 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. |
| 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Olux-E Foam Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening \[BD\]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week | 62 |
| Vehicle Foam Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week | 63 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Vehicle Foam | Total | Olux-E Foam |
|---|---|---|---|
| Age, Continuous | 47.3 Years STANDARD_DEVIATION 14.3 | 49.4 Years STANDARD_DEVIATION 15.5 | 51.5 Years STANDARD_DEVIATION 16.4 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 participants | 4 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 2 participants | 3 participants | 1 participants |
| Race/Ethnicity, Customized Black | 7 participants | 16 participants | 9 participants |
| Race/Ethnicity, Customized Multiracial | 2 participants | 3 participants | 1 participants |
| Race/Ethnicity, Customized White | 50 participants | 99 participants | 49 participants |
| Sex: Female, Male Female | 29 Participants | 70 Participants | 41 Participants |
| Sex: Female, Male Male | 34 Participants | 55 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 62 | 5 / 63 |
| serious Total, serious adverse events | 0 / 62 | 0 / 63 |
Outcome results
Primary
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.
Time frame: Baseline (Day 1) and Day 15
Population: Intent-to-Treat (ITT) Population: all randomized participants who were dispensed study product. Missing values were imputed using last observation carried forward (LOCF, i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olux-E Foam | 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 | 26 participants |
| Vehicle Foam | 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 | 18 participants |
p-value: 0.151Cochran-Mantel-Haenszel
Secondary
Number of Participants With an Improvement of at Least 1 Grade in the 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.
Time frame: Baseline (Day 1) and Day 15
Population: ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olux-E Foam | Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15 | 45 participants |
| Vehicle Foam | Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15 | 38 participants |
Secondary
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
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.
Time frame: Baseline (Day 1), Day 3, and Day 8
Population: ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | 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 | Day 3 | 24 participants |
| Olux-E Foam | 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 | Day 8 | 36 participants |
| Vehicle Foam | 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 | Day 3 | 14 participants |
| Vehicle Foam | 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 | Day 8 | 32 participants |
Secondary
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
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.
Time frame: Baseline (Day 1) and Days 3, 8, and 15
Population: ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | 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 | Day 3 | 28 participants |
| Olux-E Foam | 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 | Day 8 | 44 participants |
| Olux-E Foam | 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 | Day 15 | 51 participants |
| Vehicle Foam | 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 | Day 3 | 25 participants |
| Vehicle Foam | 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 | Day 8 | 35 participants |
| Vehicle Foam | 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 | Day 15 | 33 participants |
Secondary
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
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.
Time frame: Baseline (Day 1), Day 3, and Day 8
Population: ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | 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 | Day 3 | 2 participants |
| Olux-E Foam | 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 | Day 15 | 12 participants |
| Vehicle Foam | 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 | Day 3 | 3 participants |
| Vehicle Foam | 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 | Day 15 | 11 participants |
Secondary
Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at 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.
Time frame: Days 3, 8, and 15
Population: ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 | Day 3 | 2 participants |
| Olux-E Foam | Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 | Day 8 | 11 participants |
| Olux-E Foam | Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 | Day 15 | 24 participants |
| Vehicle Foam | Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 | Day 3 | 2 participants |
| Vehicle Foam | Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 | Day 8 | 9 participants |
| Vehicle Foam | Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 | Day 15 | 17 participants |
Secondary
Number of Participants With an SGA (Target Hand) Score of 0 or 1 at 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.
Time frame: Days 3, 8, and 15
Population: ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olux-E Foam | Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 | Day 3 | 7 participants |
| Olux-E Foam | Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 | Day 8 | 16 participants |
| Olux-E Foam | Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 | Day 15 | 32 participants |
| Vehicle Foam | Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 | Day 3 | 4 participants |
| Vehicle Foam | Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 | Day 8 | 10 participants |
| Vehicle Foam | Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15 | Day 15 | 14 participants |
Secondary
Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at 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.
Time frame: Baseline (Day 1) and Days 3, 8, and 15
Population: ITT Population. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olux-E Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Pruritus, Day 15, n=60, 59 | -65.7 Percent change in scores on a scale | Standard Deviation 38.25 |
| Olux-E Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Stinging, Day 3, n=57, 60 | -27.8 Percent change in scores on a scale | Standard Deviation 37.86 |
| Olux-E Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Pain, Day 3, n=56, 58 | -22.9 Percent change in scores on a scale | Standard Deviation 54.8 |
| Olux-E Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Stinging, Day 8, n=56, 58 | -49.2 Percent change in scores on a scale | Standard Deviation 47.25 |
| Olux-E Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Pruritus, Day 8, n=57, 57 | -48.3 Percent change in scores on a scale | Standard Deviation 46.38 |
| Olux-E Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Stinging, Day 15, n=58, 59 | -63.1 Percent change in scores on a scale | Standard Deviation 40.63 |
| Olux-E Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Pain, Day 8, n=57, 56 | -40.2 Percent change in scores on a scale | Standard Deviation 52.25 |
| Olux-E Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Burning, Day 3, n=57, 59 | -26.4 Percent change in scores on a scale | Standard Deviation 40.77 |
| Olux-E Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Burning, Day 15, n=59, 60 | -63.2 Percent change in scores on a scale | Standard Deviation 45.46 |
| Olux-E Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Burning, Day 8, n=55, 58 | -49.7 Percent change in scores on a scale | Standard Deviation 49.87 |
| Olux-E Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Pain, Day 15, n=60, 59 | -60.6 Percent change in scores on a scale | Standard Deviation 41.76 |
| Olux-E Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Pruritus, Day 3, n=58, 58 | -29.4 Percent change in scores on a scale | Standard Deviation 38.66 |
| Vehicle Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Pain, Day 15, n=60, 59 | -35.5 Percent change in scores on a scale | Standard Deviation 57.54 |
| Vehicle Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Pruritus, Day 8, n=57, 57 | -20.3 Percent change in scores on a scale | Standard Deviation 62.98 |
| Vehicle Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Burning, Day 3, n=57, 59 | -10.4 Percent change in scores on a scale | Standard Deviation 84.39 |
| Vehicle Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Burning, Day 8, n=55, 58 | -26.1 Percent change in scores on a scale | Standard Deviation 61.75 |
| Vehicle Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Pain, Day 3, n=56, 58 | -21.0 Percent change in scores on a scale | Standard Deviation 81.02 |
| Vehicle Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Pain, Day 8, n=57, 56 | -21.5 Percent change in scores on a scale | Standard Deviation 76.75 |
| Vehicle Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Pruritus, Day 15, n=60, 59 | -25.3 Percent change in scores on a scale | Standard Deviation 58.18 |
| Vehicle Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Stinging, Day 3, n=57, 60 | -1.84 Percent change in scores on a scale | Standard Deviation 85.43 |
| Vehicle Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Stinging, Day 8, n=56, 58 | -22.9 Percent change in scores on a scale | Standard Deviation 59.17 |
| Vehicle Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Stinging, Day 15, n=58, 59 | -28.9 Percent change in scores on a scale | Standard Deviation 48.48 |
| Vehicle Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Burning, Day 15, n=59, 60 | -31.1 Percent change in scores on a scale | Standard Deviation 55.67 |
| Vehicle Foam | Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15 | Pruritus, Day 3, n=58, 58 | -11.5 Percent change in scores on a scale | Standard Deviation 52.76 |