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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00828464
First received: January 22, 2009
Last updated: September 21, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Hand Dermatosis
 Drug: clobetasol propionate
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for the Condition of Chronic Hand Dermatitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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)



Secondary Outcome Measures:
  • Proportion of Subjects Who Achieve at Least a 1-grade Improvement Based on the ISGA at Day 8. [ Time Frame: Baseline, Day 8 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.


  • 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 [ Time Frame: Baseline, Day 15 ] [ Designated as safety issue: No ]

    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.


  • 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 [ Time Frame: Baseline, Day 8 ] [ Designated as safety issue: No ]

    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.


  • 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 [ Time Frame: Baseline, Day 15 ] [ Designated as safety issue: No ]

    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.


  • 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 [ Time Frame: Baseline, Day 8 ] [ Designated as safety issue: No ]

    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.


  • 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 [ Time Frame: Baseline, Day 15 ] [ Designated as safety issue: No ]

    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.


  • Change in Subject's Visual Analogue Assessment Scale From Baseline to Day 15 [ Time Frame: Baseline, Day 15 ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: October 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: clobetasol propionate foam
All subjects receive clobetasol propionate
 Drug: clobetasol propionate
Clobetasol propionate. The study product will be applied topically twice a day (morning and evening) for 14 days of treatment.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828464

Locations
United States, Kentucky
Physicians Skin Care
Louisville, Kentucky, United States, 40217
Sponsors and Collaborators
Stiefel, a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00828464     History of Changes
Other Study ID Numbers: U0280-401
Study First Received: January 22, 2009
Results First Received: April 7, 2010
Last Updated: September 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Dermatosis, Dermatitis, Dry skin, Irritated skin

Additional relevant MeSH terms:
Dermatitis
Hand Dermatoses
Skin Diseases
Clobetasol
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013