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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: The purpose of the study is to assess the safety, efficacy and tolerability of Clobetasol propionate foam in subjects with chronic dermatitis.

Detailed Summary: 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.
Sponsor: Stiefel, a GSK Company

Current Primary Outcome: Proportion of Subjects With at Least 1-grade Improvement From Baseline to Day 15 in Investigator's Static Global Assessment Score (ISGA) Score [ Time Frame: Baseline, Day 15 ]

Original Primary Outcome: Proportion of subjects who achieve improvement based on the Investigator's assessment at day 15 [ Time Frame: All Visits ]

Current Secondary Outcome:

• Proportion of Subjects Who Achieve at Least a 1-grade Improvement Based on the ISGA at Day 8. [ Time Frame: Baseline, 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)

• Change in Subject's Visual Analogue Assessment Scale [ Time Frame: Baseline, Day 8 ]
  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.
• 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 [ Time Frame: Baseline, Day 15 ]

  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.

• 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 [ 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 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.

• 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 [ Time Frame: Baseline, Day 15 ]

  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.

• Proportion of Subjects With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers [ 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 - 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.

• 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 [ 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.

  The proportion of participants is being reported as a percentage of participants.

  Each hand
  
  

  Original Secondary Outcome: Proportion of subjects who achieve improvement based on the Investigator's assessment at day 8. Change in subject's visual analogue assessment scale [ Time Frame: All Visits ]
  
  Information By: GlaxoSmithKline
  

  Dates:
  Date Received: January 22, 2009
  Date Started: October 2008
  Date Completion:
  Last Updated: September 21, 2012
  Last Verified: September 2012
  

  

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