Ignite Creation Date:
2024-05-06 @ 12:30 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01591785
Status:
COMPLETED
Last Update Posted:
2020-12-03
First Post:
2012-04-30
Brief Title:
Treatment of Staphylococcus Aureus Colonization in Hand Eczema
Sponsor:
Gary Goldenberg
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
An Investigator-Initiated Study Treatment of Staphylococcus Aureus Colonization in Hand Eczema Decreases Severity of Disease
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Atopic dermatitis is a chronic disease characterized by itching and eczematous lesions In adults eczema commonly localizes to the hands or feet Several studies have implicated bacterial contamination especially with Staphylococcus aureus S aureus to be a factor in atopic dermatitis as infection with this bacteria correlates with disease severity No trial to date has investigated how to treat S aureus infection in adults with hand or handfoot dermatitis Using retapamulin ointment in the nose and on the hands or handsfeet the investigators expect to have a significant clearance rate of s aureus infection The investigators believe that treating the bacterial infection along with treating the condition with a topical corticosteroid will significantly decrease the severity of handfoot dermatitis in our study population
Detailed Description:
Primary Study Objectives
1 To evaluate the efficacy of retapamulin 1 ointment with clobetasol propionate 005 foam versus vehicle ointment with clobetasol propionate 005 foam as a treatment regimen for hand or handfoot atopic dermatitis
2 To evaluate the incidence of intranasal and handfoot S aureus carriage rates in subjects with handfoot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the handfoot dermatitis
3 To evaluate the incidence of mupirocin-resistance and methicillin-resistance in S aureus isolates in subjects with handfoot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the handfoot dermatitis
Primary and secondary endpoints will be analyzed by appropriate statistical models by a qualified statistician Any results of this pilot study will be treated as exploratory and hypothesis generating
1 To evaluate the efficacy of retapamulin 1 ointment with clobetasol propionate 005 foam versus vehicle ointment with clobetasol propionate 005 foam as a treatment regimen for hand or handfoot atopic dermatitis
2 To evaluate the incidence of intranasal and handfoot S aureus carriage rates in subjects with handfoot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the handfoot dermatitis
3 To evaluate the incidence of mupirocin-resistance and methicillin-resistance in S aureus isolates in subjects with handfoot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the handfoot dermatitis
Primary and secondary endpoints will be analyzed by appropriate statistical models by a qualified statistician Any results of this pilot study will be treated as exploratory and hypothesis generating
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None