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Assessment of Clinical, Biological and Biometrological Paramaters in Adult Subjects Suffering From AD

Primary Purpose

Dermatitis, Atopic

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical and instrumental measurements
Sponsored by
Pierre Fabre Dermo Cosmetique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dermatitis, Atopic

Eligibility Criteria

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

Inclusion Criteria: Subject aged between 18 to 50 years included Subject suffering from Atopic Dermatitis according to the "U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis" (6) Subject with mild to moderate Atopic Dermatitis with 20 <= SCORAD <= 40 at inclusion Subject with flare frequency ≥ 4 on the target areas 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 with a target area with 22 <= target SCORAD signs <= 10 following: Erythema ≥ 1 Dryness ≥ 1 1 Subject with a control area, allowing the measurements, located on upper or lower limbs and defined as : A non- usual AD flare area according to the subject and the investigator A sufficient distance from the cutaneous target area according to the investigator Exclusion Criteria: Subject with a surinfected AD Subject having any other dermatologic condition other than AD or characteristics (e.g: tatoo) on the target area liable to interfere with the study assessments Subject with another dermatologic condition, acute or chronic or disease or history of disease considered by the investigator, liable to interfere with the study assessments, or hazardous for the subject or incompatible with the study according to the investigator Any surgical intervention on upper or lower limbs during the previous weeks or months liable to interfere with the study data according to the investigator Systemic immunosuppressive therapy (excepted systemic corticoids) within 3 months before the inclusion visit or ongoing at inclusion visit (except during flare period) Systemic corticoids taken within 4 weeks before the inclusion visit or ongoing at inclusion visit (except during flare period) Phototherapy performed within 4 weeks before the inclusion visit or ongoing at inclusion visit (except during flare period) Systemic antibiotics taken within 7 days before the inclusion visit or ongoing at inclusion visit (except during flare period) Moderate to high-potency topical corticosteroids applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit (except during flare period) Topical immunomodulators, applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit (except during flare period) Topical or oral treatment instaurated or modified before the inclusion visit or planned to be instaurated during the study or ongoing at inclusion visit, liable to interfere with the study, according to the investigator

Sites / Locations

  • Centre de Recherche sur la Peau

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All subject

Arm Description

Clinical and instrumental measurements

Outcomes

Primary Outcome Measures

Assessment of clinical parameters in Atopic Dermatitis during and outside flares-up
SCORAD (SCOring Atopic Dermatitis) and PO-SCORAD (Patient Oriented SCORing Atopic Dermatitis) are a scoring system based on the assessment of extent and intensity in a standardized manner 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
Colonization of microorganisms involved in Atopic Dermatitis flares-up from PCR analysis on a swab sample
Colonization of microorganisms will be expressed by percentage of each microorganism
Assessment of lipids profiles in Atopic Dermatitis by mass spectroscopy from swab samples
Each characteristic peak corresponding to specific lipid will be quantified by its mass intensity
Assessment of cutaneous hydratation in Atopic Dermatitis during and outside flares-up
Cutaneous hydration evaluated by humidity of the stratum corneum. The measurement is based on capacitance measurement of the stratum corneum.
Assessment of skin barrier condition in Atopic Dermatitis during and outside flares-up
The measurement is based on Trans-Epidermal Water Loss measurement
Assessment of pH in Atopic Dermatitis during and outside flares-up
pH evaluated by a pH-meters
Assessment of erythema in Atopic Dermatitis during and outside flares-up
Assessment the color of the surface of the skin

Secondary Outcome Measures

Full Information

First Posted
September 16, 2022
Last Updated
November 28, 2022
Sponsor
Pierre Fabre Dermo Cosmetique
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1. Study Identification

Unique Protocol Identification Number
NCT05639738
Brief Title
Assessment of Clinical, Biological and Biometrological Paramaters in Adult Subjects Suffering From AD
Official Title
An Exploratory and Monocentric Study to Assess Clinical, Biological and Biometrological Paramaters in Adult Subjects With Mild to Moderate Atopic Dermatitis (AD)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulties
Study Start Date
March 8, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 15, 2022 (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
The aim of the study is to collect different parameters (clinical, biological and biometrological) of Atopic Dermatitis (AD) in order to identify which factors are modified during the flare-up phase.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
All subject
Arm Type
Other
Arm Description
Clinical and instrumental measurements
Intervention Type
Other
Intervention Name(s)
Clinical and instrumental measurements
Intervention Description
Clinical evaluations Non-invasive instrumental measurements Subject's evaluations
Primary Outcome Measure Information:
Title
Assessment of clinical parameters in Atopic Dermatitis during and outside flares-up
Description
SCORAD (SCOring Atopic Dermatitis) and PO-SCORAD (Patient Oriented SCORing Atopic Dermatitis) are a scoring system based on the assessment of extent and intensity in a standardized manner 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
Change from baseline to 3 months
Title
Colonization of microorganisms involved in Atopic Dermatitis flares-up from PCR analysis on a swab sample
Description
Colonization of microorganisms will be expressed by percentage of each microorganism
Time Frame
Change from baseline to 3 months
Title
Assessment of lipids profiles in Atopic Dermatitis by mass spectroscopy from swab samples
Description
Each characteristic peak corresponding to specific lipid will be quantified by its mass intensity
Time Frame
Change from baseline to 3 months
Title
Assessment of cutaneous hydratation in Atopic Dermatitis during and outside flares-up
Description
Cutaneous hydration evaluated by humidity of the stratum corneum. The measurement is based on capacitance measurement of the stratum corneum.
Time Frame
Change from baseline to 3 months
Title
Assessment of skin barrier condition in Atopic Dermatitis during and outside flares-up
Description
The measurement is based on Trans-Epidermal Water Loss measurement
Time Frame
Change from baseline to 3 months
Title
Assessment of pH in Atopic Dermatitis during and outside flares-up
Description
pH evaluated by a pH-meters
Time Frame
Change from baseline to 3 months
Title
Assessment of erythema in Atopic Dermatitis during and outside flares-up
Description
Assessment the color of the surface of the skin
Time Frame
Change from baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject aged between 18 to 50 years included Subject suffering from Atopic Dermatitis according to the "U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis" (6) Subject with mild to moderate Atopic Dermatitis with 20 <= SCORAD <= 40 at inclusion Subject with flare frequency ≥ 4 on the target areas 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 with a target area with 22 <= target SCORAD signs <= 10 following: Erythema ≥ 1 Dryness ≥ 1 1 Subject with a control area, allowing the measurements, located on upper or lower limbs and defined as : A non- usual AD flare area according to the subject and the investigator A sufficient distance from the cutaneous target area according to the investigator Exclusion Criteria: Subject with a surinfected AD Subject having any other dermatologic condition other than AD or characteristics (e.g: tatoo) on the target area liable to interfere with the study assessments Subject with another dermatologic condition, acute or chronic or disease or history of disease considered by the investigator, liable to interfere with the study assessments, or hazardous for the subject or incompatible with the study according to the investigator Any surgical intervention on upper or lower limbs during the previous weeks or months liable to interfere with the study data according to the investigator Systemic immunosuppressive therapy (excepted systemic corticoids) within 3 months before the inclusion visit or ongoing at inclusion visit (except during flare period) Systemic corticoids taken within 4 weeks before the inclusion visit or ongoing at inclusion visit (except during flare period) Phototherapy performed within 4 weeks before the inclusion visit or ongoing at inclusion visit (except during flare period) Systemic antibiotics taken within 7 days before the inclusion visit or ongoing at inclusion visit (except during flare period) Moderate to high-potency topical corticosteroids applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit (except during flare period) Topical immunomodulators, applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit (except during flare period) Topical or oral treatment instaurated or modified before the inclusion visit or planned to be instaurated during the study or ongoing at inclusion visit, liable to interfere with the study, according to the investigator
Facility Information:
Facility Name
Centre de Recherche sur la Peau
City
Toulouse
ZIP/Postal Code
31400
Country
France

12. IPD Sharing Statement

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Assessment of Clinical, Biological and Biometrological Paramaters in Adult Subjects Suffering From AD

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