NCT00828464

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

September 28, 2010

Completed
Last Updated

October 3, 2012

Status Verified

September 1, 2012

Enrollment Period

3 months

First QC Date

January 22, 2009

Results QC Date

April 7, 2010

Last Update Submit

September 21, 2012

Conditions

Hand Dermatosis

Keywords

Dermatosis, Dermatitis, Dry skin, Irritated skin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Proportion of Subjects Who Achieve at Least a 1-grade Improvement Based on the ISGA at Day 8.

    Baseline, Day 8

  • Change in Subject's Visual Analogue Assessment Scale

    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

    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

    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

    Baseline, Day 15

  • +8 more secondary outcomes

Study Arms (1)

clobetasol propionate foam

EXPERIMENTAL

All subjects receive clobetasol propionate

Drug: clobetasol propionate

Interventions

clobetasol propionateDRUG

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

clobetasol propionate foam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physicians Skin Care

Louisville, Kentucky, 40217, United States

Location

Related Publications (1)

  • 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.

    PMID: 22134563DERIVED

MeSH Terms

Conditions

Hand DermatosesSkin DiseasesDermatitis

Interventions

Clobetasol

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BetamethasoneSteroids, FluorinatedSteroidsFused-Ring CompoundsPolycyclic Compounds

Limitations and Caveats

Open label study

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 26, 2009

Study Start

October 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

October 3, 2012

Results First Posted

September 28, 2010

Record last verified: 2012-09

Locations

US(1)