Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04553224
Status:
COMPLETED
Last Update Posted:
2020-09-17
First Post:
2020-05-14
Brief Title:
Collection of Clinical and Instrumental Data in Adult Subjects Suffering From Atopic Dermatitis
Sponsor:
Pierre Fabre Dermo Cosmetique
Organization:
Pierre Fabre Dermo Cosmetique
Study Overview
Official Title:
Collection of Clinical and Biometrological Data in Adult Subjects Suffering From Atopic Dermatitis AD During a Three-month Period
Status:
COMPLETED
Status Verified Date:
2020-05
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 represents a real challenge in public health as it affects a large percentage of children and adults Affected individuals must cope with a significant psychosocial burden in addition to dealing with the medical aspects of the disease
The purpose of this exploratory study is to collect clinical severity AD data using PO-SCORAD self-assessment by the subjects SCORAD evolution instrumental measurements and treatment follow up of subjects
The future objective is to develop a personalised prediction model of AD flares in order to improve management of AD by more accurate severity evaluations by the subject and the physician Development of a method of early detection of flares will open new treatment pathways for AD management
The purpose of this exploratory study is to collect clinical severity AD data using PO-SCORAD self-assessment by the subjects SCORAD evolution instrumental measurements and treatment follow up of subjects
The future objective is to develop a personalised prediction model of AD flares in order to improve management of AD by more accurate severity evaluations by the subject and the physician Development of a method of early detection of flares will open new treatment pathways for AD management
Detailed Description:
This study will be conducted as a French monocentric exploratory study in adults with mild to moderate Atopic Dermatitis and will be conducted on a maximum 25 included subjects
The clinical study will include 4 study visits after inclusion visit and the maximum duration of the study for each subject will be 3 months Day 1 Day 29 Day 57 Day 85
In case of AD flare suspicion the investigator may recommend a complementary visit Any complementary visit will be confirmed by investigator according to the subjects information photographs and PO-SCORAD sent by the subject If visit is confirmed it will be scheduled as soon as possible
The objectives are
to collect clinical AD severity data in order to evaluate natural AD evolution with clinical and subjects scales during a three-month period
to collect non-invasive instrumental AD data on a target area and on adjacent area cutaneous hydration epidermal barrier conditions and colorimetric parameters on cutaneous erythema
to examine clinical and instrumental AD data
to collect illustrative photographs of AD lesions
The clinical study will include 4 study visits after inclusion visit and the maximum duration of the study for each subject will be 3 months Day 1 Day 29 Day 57 Day 85
In case of AD flare suspicion the investigator may recommend a complementary visit Any complementary visit will be confirmed by investigator according to the subjects information photographs and PO-SCORAD sent by the subject If visit is confirmed it will be scheduled as soon as possible
The objectives are
to collect clinical AD severity data in order to evaluate natural AD evolution with clinical and subjects scales during a three-month period
to collect non-invasive instrumental AD data on a target area and on adjacent area cutaneous hydration epidermal barrier conditions and colorimetric parameters on cutaneous erythema
to examine clinical and instrumental AD data
to collect illustrative photographs of AD lesions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None