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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of the study is to assess the safety, efficacy and tolerability of Clobetasol propionate foam in subjects with chronic dermatitis.
The study is being conducted in order to obtain safety, efficacy and tolerability data for Clobetasol propionate foam in the treatment of chronic dermatitis. The subjects must have mild to moderate disease based on the Investigator's assessment at baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clobetasol propionate foam | Experimental | All subjects receive clobetasol propionate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clobetasol propionate | Drug | Clobetasol propionate. The study product will be applied topically twice a day (morning and evening) for 14 days of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With at Least 1-grade Improvement From Baseline to Day 15 in Investigator's Static Global Assessment Score (ISGA) Score | 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) | Baseline, Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Achieve at Least a 1-grade Improvement Based on the ISGA at Day 8. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Skin Care | Louisville | Kentucky | 40217 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22134563 | Derived | Kircik LH, Tropmann C. Treatment of mild-to-moderate chronic hand dermatitis with clobetasol propionate 0.05% EF foam: results from an open-label study. J Drugs Dermatol. 2011 Dec;10(12):1398-402. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clobetasol Propionate Foam | All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Clobetasol Propionate Foam | All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Proportion of Subjects Who Achieve at Least a 1-grade Improvement Based on the ISGA at Day 8. | 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) | ITT | Posted | Number | Percentage of Participants | Baseline, Day 8 |
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15 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clobetasol Propionate Foam | All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site burning | General disorders | MedDRA (11.1) | Non-systematic Assessment |
Open label study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D006229 | Hand Dermatoses |
| D012871 | Skin Diseases |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D002990 | Clobetasol |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Baseline, Day 8 |
| Change in Subject's Visual Analogue Assessment Scale | 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. | Baseline, Day 8 |
| 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 | 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. | Baseline, Day 15 |
| 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 | 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. | Baseline, Day 8 |
| 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 | 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. | Baseline, Day 15 |
| Proportion of Subjects With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers | 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. | Baseline, Day 8 |
| 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 | 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. | Baseline, Day 8 |
| 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 | 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. | Baseline, Day 15 |
| 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 | 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. | Baseline, Day 8 |
| 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 | 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. | Baseline, Day 15 |
| 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 | 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. | Baseline, Day 8 |
| 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 | 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. | Baseline, Day 15 |
| Change in Subject's Visual Analogue Assessment Scale From Baseline to Day 15 | 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. | Baseline, Day 15 |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| ISGA-Chronic Hand Dermatitis | Investigators Static Global Assessment (ISGA)- Chronic Hand Dermatitis Score=2 mild Score=3 moderate These are the only scores that are permitted for entry on this study. | Number | Participants |
|
| Time since Diagnosis of Chronic Hand Dermatitis (years) | Time since Diagnosis of Chronic Hand Dermatitis, Allergic, Irritant or Contact Dermatitis (years) | Mean | Standard Deviation | Years |
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| Total Hand Eczema Severity Index (HESI) | Total Hand Eczema Severity Index (total HESI) Score 0 to 360 where 0 is the best and 360 is the worst score. | Mean | Standard Deviation | Units on a scale |
|
| Counts |
|---|
| Participants |
|
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| Primary | Proportion of Subjects With at Least 1-grade Improvement From Baseline to Day 15 in Investigator's Static Global Assessment Score (ISGA) Score | 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) | Intent-to-treat (ITT). | Posted | Number | Percentage of Participants | Baseline, Day 15 |
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| Secondary | Change in Subject's Visual Analogue Assessment Scale | 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 8 |
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| Secondary | 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 | 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. | ITT | Posted | Number | Percentage of Participants | Baseline, Day 15 |
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| Secondary | 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 | 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. | ITT | Posted | Number | Percentage of Participants | Baseline, Day 8 |
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| Secondary | 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 | 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. | ITT | Posted | Number | Percentage of Participants | Baseline, Day 15 |
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| Secondary | Proportion of Subjects With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers | 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. | ITT | Posted | Number | Percentage of Participants | Baseline, Day 8 |
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| Secondary | 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 | 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. | ITT | Posted | Number | Percentage of Participants | Baseline, Day 8 |
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| Secondary | 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 | 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. | ITT | Posted | Number | Percentage of Participants | Baseline, Day 15 |
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| Secondary | 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 | 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. | ITT | Posted | Number | Percentage of Participants | Baseline, Day 8 |
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| Secondary | 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 | 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. | ITT | Posted | Number | Percentage of Participants | Baseline, Day 15 |
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| Secondary | 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 | 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. | ITT | Posted | Number | Percentage of Participants | Baseline, Day 8 |
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| Secondary | 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 | 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. | ITT | Posted | Number | Percentage of Participants | Baseline, Day 15 |
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| Secondary | Change in Subject's Visual Analogue Assessment Scale From Baseline to Day 15 | 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. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 15 |
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| 1 |
| 30 |
| 4 |
| 30 |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
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| D011083 |
| Polycyclic Compounds |