Ignite Creation Date:
2025-12-18 @ 8:38 AM
Ignite Modification Date:
2025-12-23 @ 6:57 PM
Study NCT ID:
NCT01591785
Status:
None
Last Update Posted:
2020-12-03 00:00:00
First Post:
2012-04-30 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Staphylococcus Aureus Colonization in Hand Eczema
Sponsor:
None
Organization:
Study Overview
Official Title:
An Investigator-Initiated Study: Treatment of Staphylococcus Aureus Colonization in Hand Eczema Decreases Severity of Disease
Status:
None
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:
Primary Study Objectives:
1. To evaluate the efficacy of retapamulin 1% ointment with clobetasol propionate 0.05% foam versus vehicle ointment with clobetasol propionate 0.05% foam as a treatment regimen for hand or hand/foot atopic dermatitis.
2. To evaluate the incidence of intranasal and hand/foot S aureus carriage rates in subjects with hand/foot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the hand/foot dermatitis.
3. To evaluate the incidence of mupirocin-resistance and methicillin-resistance in S aureus isolates in subjects with hand/foot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the hand/foot 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 0.05% foam versus vehicle ointment with clobetasol propionate 0.05% foam as a treatment regimen for hand or hand/foot atopic dermatitis.
2. To evaluate the incidence of intranasal and hand/foot S aureus carriage rates in subjects with hand/foot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the hand/foot dermatitis.
3. To evaluate the incidence of mupirocin-resistance and methicillin-resistance in S aureus isolates in subjects with hand/foot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the hand/foot 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.
Detailed Description:
None
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?: