Ignite Creation Date:
2024-05-06 @ 1:50 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01905631
Status:
COMPLETED
Last Update Posted:
2022-10-24
First Post:
2013-07-19
Brief Title:
Blinded Randomized Study Evaluating Aurstat Versus Control in the Treatment of Atopic Dermatitis Associated Pruritus
Sponsor:
The Center for Clinical and Cosmetic Research
Organization:
The Center for Clinical and Cosmetic Research
Study Overview
Official Title:
A 3-Day Investigator Blinded Randomized Study Evaluating Aurstat Anti-Itch Hydrogel Versus Control in the Treatment of Atopic Dermatitis Associated Pruritus
Status:
COMPLETED
Status Verified Date:
2022-10
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:
AUR0613
Brief Summary:
To demonstrate the ability of Aurstat to reduce pruritus in subjects with mild to moderate atopic dermatitis Efficacy results will be based on subject assessment IGA and photographic evidence based on ordinal scales for tolerability
Detailed Description:
This 3-day study will enroll subjects with mild to moderate atopic dermatitis as defined by the Hanifin criteria
All subjects will be screened for study enrollment at the baseline visit Those meeting inclusionexclusion criteria will be fully consented or assented using an IRB-approved ICF Subjects will then be randomized to either the treatment or control study arm Those in the treatment arm will be instructed on product application technique and study instructions at baseline Subjects will apply Aurstat BID or as needed to determine frequency of use as a surrogate marker for duration of therapy effect to affected qualifying atopic dermatitis lesions
The investigator will assess treatment response using an ordinal scale for tolerability and an IGA scale for disease severity ratings Subjects will assess treatment response using a VAS to rate pruritus and an ordinal scale to assess tolerability Photography assessments will be obtained All adverse events will be captured
All subjects will be screened for study enrollment at the baseline visit Those meeting inclusionexclusion criteria will be fully consented or assented using an IRB-approved ICF Subjects will then be randomized to either the treatment or control study arm Those in the treatment arm will be instructed on product application technique and study instructions at baseline Subjects will apply Aurstat BID or as needed to determine frequency of use as a surrogate marker for duration of therapy effect to affected qualifying atopic dermatitis lesions
The investigator will assess treatment response using an ordinal scale for tolerability and an IGA scale for disease severity ratings Subjects will assess treatment response using a VAS to rate pruritus and an ordinal scale to assess tolerability Photography assessments will be obtained All adverse events will be captured
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