Skin Efficacy and Tolerability of a Cosmetic Product Combination Over 3 Months in Subjects With Atopic Eczema (AtoCare-OS)

Bionorica

Status

Active, not recruiting

Conditions

Atopic Dermatitis

Eczema-Prone Skin

Treatments

Other: Body Lotion and Intensive Care

Study type

Interventional

Funder types

Industry

Identifiers

NCT05790083

AtoCare-OS

Details and patient eligibility

About

The aim of this exploratory study is to investigate the short- and long-term efficacy and tolerability of a cosmetic product combination consisting of a body lotion and an intensive care product in subjects with atopic eczema over 3 months of use. Efficacy is assessed by instrumental measurements of skin condition (sub-panel), clinical examinations, and questionnaires.

Full description

The objective of this exploratory study is to investigate the short- and long-term efficacy and tolerability of a cosmetic product combination consisting of a body lotion and an intensive care product in subjects with atopic eczema over 3 months of use.

For efficacy and tolerability evaluation, an objective dermatological assessment will be performed, in addition to assessing efficacy, the severity of atopic eczema will be assessed using the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). Further, the effect of the test product combination on symptom severity, disease control (recap of atopic eczema (RECAP)), quality of life and well-being will be evaluated by the subjects or the subjects' parents/ legal guardians. The subjects or the subjects' parents/ legal guardians will also document the frequency of flare-ups, required physician visits and the use of cortisone administration as well as their/ their child's well-being in a diary.

Additionally, the influence of the test product combination on the skin barrier will be assessed in a sub-panel with dry legs by measuring the transepidermal water loss by Aquaflux and by sampling of biological material for analysis of skin lipids and corneocyte maturity before and after 3 months of product use.

Enrollment

100 patients

Sex

All

Ages

2 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Written Informed Consent of the subject to participate in the study, or, for underaged subjects of the parents/ legal guardians to let their child participate in the study
Willingness to actively participate in the study and to come to the scheduled visits or, for underaged subjects, willingness of the parents/ legal guardians to actively support their child's participation in the study and to come to the scheduled visits with their child
Female and/or male
Children from 2 to 17 years of age and adult subjects between 18 and 75 years of age
Eczema-prone skin and atopic dermatitis, diagnosed by the dermatologist

Exclusion criteria

Female subjects (only of childbearing age): Pregnancy or lactation
Drug addicts, alcoholics (only adults)
AIDS, HIV-positive or infectious hepatitis
Conditions which exclude a participation or might influence the test reaction/evaluation
Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
Insulin-dependent diabetes mellitus
One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases
Documented allergies to cosmetic products and/or ingredients, skin care and/ or skin cleansing products as well as to ingredients of the test products
Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids, cyclosporine, dupilumab) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study
Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac, ibuprofen), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study
Any topical medicinal products (e.g. topical corticosteroids, calcineurin inhibitors) at the test area within the last 5 days prior to the start of the study
Any topical medication at the test area throughout the entire course of the study (except the medication normally used for treatment of atopic eczema)