Trial Outcomes & Findings for Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for Chronic Hand Dermatitis (NCT NCT00828464)

Results Overview

Proportion of Subjects with at least a 1-Grade Improvement from Baseline to Day 15 In Investigator's Static Global Assessment Score (ISGA) - Chronic Hand Dermatitis Please note that the proportion of participants is being reported as a percentage of participants. ISGA grades: Score = 0 (Clear) Score = 1 (Almost Clear) Score = 2 (Mild) Score = 3 (Moderate) Score = 4 (Severe)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

Baseline, Day 15

Results posted on

2012-10-03

Participant Flow

* Recruitment period: First Subject Enrolled October 2008, Last Subject Enrolled January 2009. * Type of location: Dermatology Research Center

1. Washout from use of systemic corticosteroid and/or other prohibited medications if used within 4 weeks of the baseline visit. 2. Washout from use of topical corticosteroid therapy and/or other prohibited topical medications if used within 2 weeks prior to the baseline visit

Participant milestones

Participant milestones
Measure	Clobetasol Propionate Foam All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Overall Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Clobetasol Propionate Foam All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for Chronic Hand Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clobetasol Propionate Foam n=30 Participants All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age Continuous	47.5 years STANDARD_DEVIATION 14.9 • n=93 Participants
Sex: Female, Male Female	16 Participants n=93 Participants
Sex: Female, Male Male	14 Participants n=93 Participants
Region of Enrollment United States	30 participants n=93 Participants
ISGA-Chronic Hand Dermatitis Mild	16 Participants n=93 Participants
ISGA-Chronic Hand Dermatitis Moderate	14 Participants n=93 Participants
Time since Diagnosis of Chronic Hand Dermatitis (years)	18.92 Years STANDARD_DEVIATION 15 • n=93 Participants
Total Hand Eczema Severity Index (HESI)	32.1 Units on a scale STANDARD_DEVIATION 17.0 • n=93 Participants

PRIMARY outcome

Timeframe: Baseline, Day 15

Population: Intent-to-treat (ITT).

Proportion of Subjects with at least a 1-Grade Improvement from Baseline to Day 15 In Investigator's Static Global Assessment Score (ISGA) - Chronic Hand Dermatitis Please note that the proportion of participants is being reported as a percentage of participants. ISGA grades: Score = 0 (Clear) Score = 1 (Almost Clear) Score = 2 (Mild) Score = 3 (Moderate) Score = 4 (Severe)

Outcome measures

Outcome measures
Measure	Clobetasol Propionate Foam n=30 Participants All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Proportion of Subjects With at Least 1-grade Improvement From Baseline to Day 15 in Investigator's Static Global Assessment Score (ISGA) Score	96.7 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Day 8

Population: ITT

Please note that the proportion of participants is being reported as a percentage of participants. Investigator's Static Global Assessment Score (ISGA) At least 1-grade improvement (%) at Day 8 ISGA grades: Score = 0 (Clear) Score = 1 (Almost Clear) Score = 2 (Mild) Score = 3 (Moderate) Score = 4 (Severe)

Outcome measures

Outcome measures
Measure	Clobetasol Propionate Foam n=30 Participants All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Proportion of Subjects Who Achieve at Least a 1-grade Improvement Based on the ISGA at Day 8.	76.7 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Day 8

Population: ITT. Twenty-nine of the 30 subjects enrolled on this study had results for this endpoint on day 8. Thirty of the 30 subjects enrolled had results for this same assessment at the day 15 visit.

Mean change in subject's visual analogue assessment scale from baseline to day 8. At each visit, the subject is requested to rate the changes in their skin on the hands on a 1 to 10 scale with 0 being poor and 10 being excellent.

Outcome measures

Outcome measures
Measure	Clobetasol Propionate Foam n=29 Participants All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Change in Subject's Visual Analogue Assessment Scale	1.46 Units on a scale Standard Deviation 2.25

SECONDARY outcome

Timeframe: Baseline, Day 15

Population: ITT

Proportion of subjects at day 15 with at least 1-Grade improvement in the Hand Eczema Severity Index Score (HESI) for all symptoms present at baseline - Finger Tips. The proportion of participants is being reported as a percentage of participants. Each hand was divided into five areas \[fingertips, fingers (except the tips), palms, back of hands and wrists\]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe.

Outcome measures

Outcome measures
Measure	Clobetasol Propionate Foam n=30 Participants All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips	73.3 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Day 8

Population: ITT

Proportion of Subjects at day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips The proportion of participants is being reported as a percentage of participants. Each hand was divided into five areas \[fingertips, fingers (except the tips), palms, back of hands and wrists\]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe.

Outcome measures

Outcome measures
Measure	Clobetasol Propionate Foam n=30 Participants All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips	43.3 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Day 15

Population: ITT

Proportion of Subjects at day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers. The proportion of participants is being reported as a percentage of participants. Each hand was divided into five areas \[fingertips, fingers (except the tips), palms, back of hands and wrists\]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe.

Outcome measures

Outcome measures
Measure	Clobetasol Propionate Foam n=30 Participants All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Fingers	70 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Day 8

Population: ITT

Proportion of Subjects at day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Fingers The proportion of participants is being reported as a percentage of participants. Each hand was divided into five areas \[fingertips, fingers (except the tips), palms, back of hands and wrists\]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe.

Outcome measures

Outcome measures
Measure	Clobetasol Propionate Foam n=30 Participants All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Proportion of Subjects With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers	50 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Day 8

Population: ITT

Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Palm of Hands. The proportion of participants is being reported as a percentage of participants. Each hand was divided into five areas \[fingertips, fingers (except the tips), palms, back of hands and wrists\]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe.

Outcome measures

Outcome measures
Measure	Clobetasol Propionate Foam n=30 Participants All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands	56.7 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Day 15

Population: ITT

Proportion of Subjects at Day 15 with at least a 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands The proportion of participants is being reported as a percentage of participants. Each hand was divided into five areas \[fingertips, fingers (except the tips), palms, back of hands and wrists\]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe.

Outcome measures

Outcome measures
Measure	Clobetasol Propionate Foam n=30 Participants All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands	73.3 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Day 8

Population: ITT

Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands. The proportion of participants is being reported as a percentage of participants. Each hand was divided into five areas \[fingertips, fingers (except the tips), palms, back of hands and wrists\]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe.

Outcome measures

Outcome measures
Measure	Clobetasol Propionate Foam n=30 Participants All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands	33.3 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Day 15

Population: ITT

Proportion of Subjects at Day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands. The proportion of participants is being reported as a percentage of participants. Each hand was divided into five areas \[fingertips, fingers (except the tips), palms, back of hands and wrists\]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe.

Outcome measures

Outcome measures
Measure	Clobetasol Propionate Foam n=30 Participants All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands	66.7 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Day 8

Population: ITT

Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists. The proportion of participants is being reported as a percentage of participants. Each hand was divided into five areas \[fingertips, fingers (except the tips), palms, back of hands and wrists\]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe.

Outcome measures

Outcome measures
Measure	Clobetasol Propionate Foam n=30 Participants All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists	40 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Day 15

Population: ITT

Proportion of Subjects at Day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI)for All Symptoms Present at Baseline Wrists. The proportion of participants is being reported as a percentage of participants. Each hand was divided into five areas \[fingertips, fingers (except the tips), palms, back of hands and wrists\]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe.

Outcome measures

Outcome measures
Measure	Clobetasol Propionate Foam n=30 Participants All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists	40 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Day 15

Population: ITT

Mean change in subject's visual analogue assessment scale from baseline to day 15. At each visit, the subject is requested to rate the changes in their skin on the hands on a 1 to 10 scale with 0 being poor and 10 being excellent.

Outcome measures

Outcome measures
Measure	Clobetasol Propionate Foam n=30 Participants All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Change in Subject's Visual Analogue Assessment Scale From Baseline to Day 15	3.40 Units on a scale Standard Deviation 2.50

Adverse Events

Clobetasol Propionate Foam

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Clobetasol Propionate Foam n=30 participants at risk All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
Infections and infestations Skin infection	3.3% 1/30 • Number of events 1 • 15 days

Other adverse events

Other adverse events
Measure	Clobetasol Propionate Foam n=30 participants at risk All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
General disorders Application site burning	6.7% 2/30 • Number of events 2 • 15 days
Respiratory, thoracic and mediastinal disorders Sinus congestion	6.7% 2/30 • Number of events 2 • 15 days

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60