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Collection of Clinical and Instrumental Data in Adult Subjects Suffering From Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical evaluations
Non-invasive instrumental measurements
Subject's evaluations
Sponsored by
Pierre Fabre Dermo Cosmetique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Only most important inclusion and exclusion criteria are listed : those which are study specific.

Inclusion Criteria:

  • Subject suffering from Atopic Dermatitis according to the U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis (3).
  • Subject with mild to moderate Atopic Dermatitis with 20 <= SCORAD <= 40 at inclusion
  • Subject with flare frequency ≥ 4 over the last year
  • Subject with a cutaneous target area, allowing the measurements, located on upper or lower limbs and defined as a usual AD flare area according to the subject
  • Subject owning a smartphone suitable with the 5.0 downloaded version of PO-Scorad® app
  • Subject who agrees to use daily a free mobile app: PO-Scorad®

Exclusion Criteria:

  • Subject having received artificial UV exposure or excessive exposure to natural sunlight within the 2 weeks before the inclusion visit or planning to be exposed to excessive or prolonged natural sunlight or UV exposures for the duration of the study
  • Subject with a hirsute target area
  • Systemic immunosuppressive therapy (excepted systemic corticoids) within 3 months before the inclusion visit or ongoing at inclusion visit.
  • Systemic corticoids taken (whatever the number of intake) within 4 weeks before the inclusion visit or ongoing at inclusion visit.
  • Phototherapy performed within 4 weeks before the inclusion visit or ongoing at inclusion visit
  • Systemic antibiotics taken within 7 days before the inclusion visit or ongoing at inclusion visit.
  • Moderate to high-potency topical corticosteroids applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit
  • Topical immunomodulators (TIMs), applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit
  • Any topical treatment or product applied between the evening before the inclusion visit and the inclusion visit
  • Water applied on target area within 4 hours before the inclusion visit

Sites / Locations

  • Skin Research Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All Subjects

Arm Description

Clinical and instrumental measurements

Outcomes

Primary Outcome Measures

Change on clinical evaluation (investigator evaluation) : SCORAD
The SCORAD is a scoring system based on the assessment of extent and intensity in a standardized manner
Change on clinical evaluation (investigator evaluation) : Target SCORAD
Target SCORAD is the sum of all SCORAD objective signs scores: erythema, oedema/papulation, oozing/crusts, excoriation, lichenification and dryness evaluated on a target area
Change on instrumental measurement performed by investigational team : TEWL
TEWL: Transepidermal water loss. TEWL tracks the passage of water through the skin
Change on instrumental measurement performed by investigational team : Lipidic analysis
The proportion of lipids will be analysed on specific bands of infrared spectra by calculation of area under curve of the peaks
Change on instrumental measurement performed by investigational team : cutaneous hydration
Cutaneous hydration evaluated by humidity of the stratum corneum. The measurement is based on capacitance measurement of the stratum corneum.
Change on instrumental measurement performed by investigational team : colorimetric parameter of cutaneous erythema
Evaluation with objective assessment the color of the surface of the skin. Data output will be in the form of the L* a* b* color coordinate system. The a* values (red/ green) will be assessed for quantifying the degree of erythema.
Change on instrumental measurement by subject
hydration index : mean value measured by a measuring pen on the skin
Change on Subject's evaluations : subject evaluation
PO-SCORAD : a fully validated self-assessment of the AD severity adapted from the SCORAD index; it is available on mobile's phone application.
Change on Subject's evaluation : subject evaluation
target PO-SCORAD : The target PO-SCORAD is the sum of all PO-SCORAD objective signs scores: dryness of the skin without eczema, redness of the skin affected by eczema, swelling, oozing/ crust, scratching and thickening evaluated on the target area
Change on Subject's evaluation : subject evaluation
Subject's questionnaire on lifestyle modifications, as potential flare triggers.

Secondary Outcome Measures

Full Information

First Posted
May 14, 2020
Last Updated
September 11, 2020
Sponsor
Pierre Fabre Dermo Cosmetique
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1. Study Identification

Unique Protocol Identification Number
NCT04553224
Brief Title
Collection of Clinical and Instrumental Data in Adult Subjects Suffering From Atopic Dermatitis
Official Title
Collection of Clinical and Biometrological Data in Adult Subjects Suffering From Atopic Dermatitis (AD) During a Three-month Period
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
February 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Dermo Cosmetique

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 subject's 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 subject's 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Subjects
Arm Type
Other
Arm Description
Clinical and instrumental measurements
Intervention Type
Other
Intervention Name(s)
Clinical evaluations
Intervention Description
SCORAD and target SCORAD
Intervention Type
Other
Intervention Name(s)
Non-invasive instrumental measurements
Intervention Description
TEWL, cutaneous hydration, skin lipidic analysis, colorimetry, hydration index
Intervention Type
Other
Intervention Name(s)
Subject's evaluations
Intervention Description
PO-SCORAD, target PO-SCORAD and subject's questionnaire
Primary Outcome Measure Information:
Title
Change on clinical evaluation (investigator evaluation) : SCORAD
Description
The SCORAD is a scoring system based on the assessment of extent and intensity in a standardized manner
Time Frame
Day1, Day29, Day57 and Day85
Title
Change on clinical evaluation (investigator evaluation) : Target SCORAD
Description
Target SCORAD is the sum of all SCORAD objective signs scores: erythema, oedema/papulation, oozing/crusts, excoriation, lichenification and dryness evaluated on a target area
Time Frame
Day1, Day29, Day57 and Day85
Title
Change on instrumental measurement performed by investigational team : TEWL
Description
TEWL: Transepidermal water loss. TEWL tracks the passage of water through the skin
Time Frame
Day1, Day29, Day57 and Day85
Title
Change on instrumental measurement performed by investigational team : Lipidic analysis
Description
The proportion of lipids will be analysed on specific bands of infrared spectra by calculation of area under curve of the peaks
Time Frame
Day1, Day29, Day57 and Day85
Title
Change on instrumental measurement performed by investigational team : cutaneous hydration
Description
Cutaneous hydration evaluated by humidity of the stratum corneum. The measurement is based on capacitance measurement of the stratum corneum.
Time Frame
Day1, Day29, Day57 and Day85
Title
Change on instrumental measurement performed by investigational team : colorimetric parameter of cutaneous erythema
Description
Evaluation with objective assessment the color of the surface of the skin. Data output will be in the form of the L* a* b* color coordinate system. The a* values (red/ green) will be assessed for quantifying the degree of erythema.
Time Frame
Day1, Day29, Day57 and Day85
Title
Change on instrumental measurement by subject
Description
hydration index : mean value measured by a measuring pen on the skin
Time Frame
each day, during 3 months
Title
Change on Subject's evaluations : subject evaluation
Description
PO-SCORAD : a fully validated self-assessment of the AD severity adapted from the SCORAD index; it is available on mobile's phone application.
Time Frame
each day during 3 months
Title
Change on Subject's evaluation : subject evaluation
Description
target PO-SCORAD : The target PO-SCORAD is the sum of all PO-SCORAD objective signs scores: dryness of the skin without eczema, redness of the skin affected by eczema, swelling, oozing/ crust, scratching and thickening evaluated on the target area
Time Frame
on Day1, Day29, Day57 and Day85
Title
Change on Subject's evaluation : subject evaluation
Description
Subject's questionnaire on lifestyle modifications, as potential flare triggers.
Time Frame
once a month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Only most important inclusion and exclusion criteria are listed : those which are study specific. Inclusion Criteria: Subject suffering from Atopic Dermatitis according to the U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis (3). Subject with mild to moderate Atopic Dermatitis with 20 <= SCORAD <= 40 at inclusion Subject with flare frequency ≥ 4 over the last year Subject with a cutaneous target area, allowing the measurements, located on upper or lower limbs and defined as a usual AD flare area according to the subject Subject owning a smartphone suitable with the 5.0 downloaded version of PO-Scorad® app Subject who agrees to use daily a free mobile app: PO-Scorad® Exclusion Criteria: Subject having received artificial UV exposure or excessive exposure to natural sunlight within the 2 weeks before the inclusion visit or planning to be exposed to excessive or prolonged natural sunlight or UV exposures for the duration of the study Subject with a hirsute target area Systemic immunosuppressive therapy (excepted systemic corticoids) within 3 months before the inclusion visit or ongoing at inclusion visit. Systemic corticoids taken (whatever the number of intake) within 4 weeks before the inclusion visit or ongoing at inclusion visit. Phototherapy performed within 4 weeks before the inclusion visit or ongoing at inclusion visit Systemic antibiotics taken within 7 days before the inclusion visit or ongoing at inclusion visit. Moderate to high-potency topical corticosteroids applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit Topical immunomodulators (TIMs), applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit Any topical treatment or product applied between the evening before the inclusion visit and the inclusion visit Water applied on target area within 4 hours before the inclusion visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier COUSTOU, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skin Research Centre
City
Toulouse
ZIP/Postal Code
31300
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.poscorad.com/
Description
free mobile app: PO-Scorad®

Learn more about this trial

Collection of Clinical and Instrumental Data in Adult Subjects Suffering From Atopic Dermatitis

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