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

Stiefel, a GSK Company30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hand Dermatosis

Interventions

clobetasol propionateDRUG

Clobetasol propionate. The study product will be applied topically twice a day (morning and evening) for 14 days of treatment.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Physicians Skin Care

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

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)

Time frame: Baseline, Day 15

Secondary Outcomes

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)

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, Day 15