Trial Outcomes & Findings for Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis. (NCT NCT01323673)
NCT ID: NCT01323673
Last Updated: 2018-06-20
Results Overview
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.
COMPLETED
PHASE4
125 participants
Baseline (Day 1) and Day 15
2018-06-20
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
63
|
|
Overall Study
COMPLETED
|
59
|
58
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
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
Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis.
Baseline characteristics by cohort
| Measure |
Olux-E Foam
n=62 Participants
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
|
Vehicle Foam
n=63 Participants
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
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.5 Years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
47.3 Years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
49.4 Years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
49 participants
n=5 Participants
|
50 participants
n=7 Participants
|
99 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Day 15Population: 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).
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.
Outcome measures
| Measure |
Olux-E Foam
n=62 Participants
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
|
Vehicle Foam
n=63 Participants
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
|
|---|---|---|
|
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
|
18 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 15Population: 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).
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.
Outcome measures
| Measure |
Olux-E Foam
n=62 Participants
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
|
Vehicle Foam
n=63 Participants
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
|
|---|---|---|
|
Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15
|
45 participants
|
38 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 3, and Day 8Population: 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).
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.
Outcome measures
| Measure |
Olux-E Foam
n=62 Participants
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
|
Vehicle Foam
n=63 Participants
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
|
|---|---|---|
|
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
|
3 participants
|
|
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
|
11 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 3, and Day 8Population: 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).
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.
Outcome measures
| Measure |
Olux-E Foam
n=62 Participants
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
|
Vehicle Foam
n=63 Participants
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
|
|---|---|---|
|
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
|
14 participants
|
|
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
|
32 participants
|
SECONDARY outcome
Timeframe: Days 3, 8, and 15Population: 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).
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.
Outcome measures
| Measure |
Olux-E Foam
n=62 Participants
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
|
Vehicle Foam
n=63 Participants
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
|
|---|---|---|
|
Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15
Day 3
|
2 participants
|
2 participants
|
|
Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15
Day 8
|
11 participants
|
9 participants
|
|
Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15
Day 15
|
24 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Days 3, 8, and 15Population: 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).
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.
Outcome measures
| Measure |
Olux-E Foam
n=62 Participants
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
|
Vehicle Foam
n=63 Participants
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
|
|---|---|---|
|
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
|
25 participants
|
|
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
|
35 participants
|
|
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
|
33 participants
|
SECONDARY outcome
Timeframe: Days 3, 8, and 15Population: 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).
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.
Outcome measures
| Measure |
Olux-E Foam
n=62 Participants
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
|
Vehicle Foam
n=63 Participants
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
|
|---|---|---|
|
Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15
Day 8
|
16 participants
|
10 participants
|
|
Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15
Day 15
|
32 participants
|
14 participants
|
|
Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15
Day 3
|
7 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Days 3, 8, and 15Population: ITT Population. Only those participants contributing data at the indicated time points were analyzed.
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.
Outcome measures
| Measure |
Olux-E Foam
n=60 Participants
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
|
Vehicle Foam
n=60 Participants
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
|
|---|---|---|
|
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
|
-11.5 Percent change in scores on a scale
Standard Deviation 52.76
|
|
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
|
-20.3 Percent change in scores on a scale
Standard Deviation 62.98
|
|
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
|
-25.3 Percent change in scores on a scale
Standard Deviation 58.18
|
|
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
|
-1.84 Percent change in scores on a scale
Standard Deviation 85.43
|
|
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
|
-22.9 Percent change in scores on a scale
Standard Deviation 59.17
|
|
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
|
-28.9 Percent change in scores on a scale
Standard Deviation 48.48
|
|
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
|
-10.4 Percent change in scores on a scale
Standard Deviation 84.39
|
|
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
|
-26.1 Percent change in scores on a scale
Standard Deviation 61.75
|
|
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
|
-31.1 Percent change in scores on a scale
Standard Deviation 55.67
|
|
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 54.80
|
-21.0 Percent change in scores on a scale
Standard Deviation 81.02
|
|
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
|
-21.5 Percent change in scores on a scale
Standard Deviation 76.75
|
|
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
|
-35.5 Percent change in scores on a scale
Standard Deviation 57.54
|
Adverse Events
Olux-E Foam
Vehicle Foam
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Olux-E Foam
n=62 participants at risk
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
|
Vehicle Foam
n=63 participants at risk
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
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
0.00%
0/62
|
1.6%
1/63
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.6%
1/62
|
0.00%
0/63
|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
1/62
|
0.00%
0/63
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/62
|
0.00%
0/63
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/62
|
0.00%
0/63
|
|
General disorders
Application Site Pruritus
|
1.6%
1/62
|
0.00%
0/63
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
3/62
|
1.6%
1/63
|
|
Infections and infestations
Sinusitis
|
1.6%
1/62
|
1.6%
1/63
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.6%
1/62
|
0.00%
0/63
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
1.6%
1/62
|
0.00%
0/63
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/62
|
0.00%
0/63
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.6%
1/62
|
0.00%
0/63
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/62
|
1.6%
1/63
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/62
|
1.6%
1/63
|
|
Skin and subcutaneous tissue disorders
Skin Burning Sensation
|
1.6%
1/62
|
0.00%
0/63
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
0.00%
0/62
|
1.6%
1/63
|
|
Vascular disorders
Flushing
|
1.6%
1/62
|
0.00%
0/63
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER