NCT04553224

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

Collection of Clinical and Biometrological Data in Adult Subjects Suffering From Atopic Dermatitis (AD) During a Three-month Period

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
OTHER	Clinical evaluations	SCORAD and target SCORAD
OTHER	Non-invasive instrumental measurements	TEWL, cutaneous hydration, skin lipidic analysis, colorimetry, hydration index
OTHER	Subject's evaluations	PO-SCORAD, target PO-SCORAD and subject's questionnaire

Timeline

• Start date: 2019-11-12
• Primary completion: 2020-02-10
• Completion: 2020-02-10
• First posted: 2020-09-17
• Last updated: 2020-09-17

Locations

1 site across 1 country: France