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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open Label Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for the Condition of Chronic Hand Dermatitis

Conditions
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Hand Dermatosis

Intervention / Treatment
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* Drug: clobetasol propionate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects 18 years of age or older, with diagnosis of chronic dermatitis, able to complete the study and comply with study instructions. Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception Exclusion Criteria: Use of systemic corticosteroid and/or other prohibited medications within 4 weeks of the baseline visit. Use of topical corticosteroid therapy and/or other prohibited topical medications within 2 weeks prior to the baseline visit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clobetasol propionate foam<br>All subjects receive clobetasol propionate | Drug: clobetasol propionate<br>* Clobetasol propionate. The study product will be applied topically twice a day (morning and evening) for 14 days of treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermatosis, Dermatitis, Dry skin, Irritated skin